Acid vs. Alkaline cleaners

Question:
What are the differences between acid cleaners and alkaline cleaners?

Answer:
Acidic cleaners are commonly used to brighten or etch metals and are effective at removing any mineral deposits or oxidation on surfaces. Generally, acidic cleaners are also ideal for removing ant starches, carbonates, and insoluble hydroxides. Since most soils are acidic, alkaline cleaners are very effective. Alkaline cleaners remove oils, fats, greases, proteins and an array of other soils. Most cleaning applications will involve an alkaline cleaner or a combination of an alkaline cleaner and an acidic cleaner. Alconox offers acidic and alkaline cleaners for pharmaceutical, medical device, manufacturing and various other industries. For information on all Alconox brands, visit www.alconox.com.

Phosphate Free Detergents

Question:
Which Alconox detergents are phosphate-free?

Answer:
Alconox supplies several phosphate-free detergents. Acid cleaners, Citranox ideal for ultrasonic and manual cleaning and low foaming Citrajet, which is recommended for machine washing and CIP cleaning are phosphate-free. Solujet, low foaming phosphate- free detergent is optimal for CIP cleaning on pharma process equipment and phosphate sensitive lab equipment. Tergajet, low foaming powdered detergent is phosphate free and is used in water testing labs. Liquinox, critical cleaning liquid detergent is a high emulsifying phosphate free detergent commonly used in medical device manufacturing and pharmaceutical processes.

To discuss which phosphate free cleaner is best suited for your cleaning application, speak to an Alconox critical cleaning expert. Also consult with Alconox about cleaning validation support. Call 914.948.4040 or email cleaning@alconox.com.

Detergent Selection Guide

Question:
Does Alconox provide any literature on how to select the correct detergent for various applications?

Answer:
Yes! The Alconox Guide to Critical Cleaning contains a detergent selection guide as well as industry specific cleaning information for Medical Device Manufacturing, the Pharmaceutical industry, Laboratory, the Environmental industry, and various other industries. The guide provides critical cleaning procedures which includes directions for Alconox detergents, cleaning method instructions for Ultrasonic, CIP, and various other methods.

To request The Guide to Critical Cleaning visit please visit here.

Soak Cleaning for removal of blood and body fluid

Question:
Which Alconox cleaner would be recommended for soak cleaning stainless steel instruments soiled by blood and body fluids?

Answer:
For removal for blood and body fluids, Alconox recommends using Tergazyme, Enzyme Active Powdered Detergent. Tergazyme is USDA authorized for use in federally inspected meat and poultry plants and is FDA certified.
Read more about Tergazyme here.

Ideal Temperature for Cleaning

Question:
What is the ideal temperature for cleaning ultrasonically and spray washing?

Answer:
The Aqueous Cleaning Handbook, written by the technical support team at Alconox, discusses heat and cleaning applications on page 23.

In general, higher-temperature cleaning solutions result in better cleaning. In practice, there is typically an optimum temperature for a given combination of cleaning variables. Many soak, manual, and ultrasonic cleaning methods work best, for example, at 50°C to 55°C. Many spray washing techniques work best at 60°C to 70°C.

To request a copy of The Aqueous Cleaning Handbook, please visit this page.

pH of Tergazyme

Question:
Can you lower the pH of Tergazyme using Citric acid or vinegar?

Answer:
Yes. To adjust the pH of a 1% Tergazyme solution from pH 9.5 to about pH 8.5 add 0.1 grams of 99% anhydrous citric acid for each 5 grams of Tergazyme. To get to pH 8.0 add 0.2 oz of citric acid. White table vinegar that is typically 5-8% active by weight, use roughly 2 ounces of vinegar added to 4 gallons of 1% Tergazyme solution that has 5 ounces of Tergazyme in it to get about a pH 8.5 solution, and use roughly 4 ounces of vinegar to get a pH 8.0 solution. Use a calibrated pH meter with stirring to monitor additions.

To view the technical bulletin for Tergazyme, please download this PDF.

Defining Free Rinsing

Question:
What does free rinsing mean?

Answer:
Free rinsing means it will rinse away very easily or freely. It does not mean that you do not have to rinse. For example a non-free rinsing cleaner might contain fragrances that were designed to deposit and leave a fresh scent, or it might contain corrosion inhibitors that are designed to deposit and leave behind an anti-corrosion film. Alconox, Inc, cleaners are free rinsing and do not leave deposits on substrates after rinsing. More information on Alconox cleaners can be found by visiting www.alconox.com.

Removing Polishing Compound

Question:
What Alconox product is ideal for manual removal of polishing compound from aluminum?

Answer:
For manual cleaning use a warm 2% Citranox solution to remove the polishing compound. Citranox will not harm the mirror finish on the aluminum. Rinse thoroughly after washing.

For more information on Citranox, visit the Alconox website.

Rinsing

Question:
What is the proper way to rinse after using Alconox detergents?

Answer:
Running water rinse for at least 10 seconds on each surface is desirable. If that is not practical, use a series of three or more agitated soak rinse tanks or at least two counter-flow cascade rinse tanks. The quality of the rinse water is important for medical device and pharmaceutical cleaning applications. Tap water contains varying degrees of organic microbes, particulates, and hardness (calcium and magnesium salts). Rinsing with tap water and evaporating dry can deposit these contaminants leaving water spots. Using high purity water such as distilled water, deionized water, or RO (reverse osmosis) water are ideal for use.

To read more about rinsing, the Alconox Guide to Critical Cleaning is available in pdf format.

Cleaning Lidocaine and Dextrose

Question:
What Alconox brand cleaner would be best for cleaning Lidocaine and Dextrose?

Answer:
Lidocaine and Dextrose are water soluble 4100 mg/L, pKa 8.01. They would be best cleaned by Liquinox. Also, Citranox would also work.

Trace Analysis for Alconox, Powdered Precision Cleaner

Question:
Is there a trace of bromine in Alconox?

Answer:
There is a typical trace content of 35 ppm bromine. Most if not all of that bromine is in the form of bromide.

Downloadable Trace Analysis Certificates are available from www.alconox.com for all Alconox brand products.

Cleaning Narrow Neck Flasks

Question:
What is the proper way to clean narrow neck flasks?

Answer:
Narrow neck flasks are best cleaned in labware washers with special attachments that have a spray nozzle that goes up inside the flask. It is very hard to successfully clean narrow neck flasks in a simple home dishwasher or a lab washer that does not have special narrow neck flask racks. The only way to do this is to presoak the narrow neck flasks completely submerged with all the air let out in a 1% Alconox or Liquinox solution prior to "washing" in the machine. Even this can fail if the other glassware cleaned at the same time has a large amount of residue on it which can redeposit on the narrow neck flasks and not be prevented from staying there by the anti-redeposition agents because there can be inadequate amounts of wash solution getting in to the narrow neck flasks without the special wash spindles.

Residue Acceptance Criteria

Question:
Do you have to set residue acceptance criteria for cleaners?

Answer:
Yes. For pharmaceutical and medical device manufacturing it is required that there be set residue acceptance levels for potential residues such as the active drug, excipients, degradation products, cleaning agents, bioburden and endotoxins. These levels are determined based on potential pharmacological, safety, toxicity, stability, and contamination effects on the next product using that surface or equipment. Limits are typically set for visual, chemical, and microbiological residues.

For more information on residue acceptance criteria, visit http://www.alconox.com/static/section_top/gen_cleanval.asp.

Alconox Cleaning Validation Literature

Question:
Does Alconox offer literature on cleaning validation?

Answer:
Yes! Alconox, Inc, Critical Cleaning Experts, provide a variety of cleaning validation information, which includes validation literature. The Aqueous Cleaning Handbook, written by the Technical Support Team at Alconox, has a chapter dedicated to Cleaning Validation (Chapter8). For more information on The Aqueous Cleaning Handbook visit, http://www.alconox.com/section_customer/book_info.asp.

Residue Detection by UV/Vis

Question:
Does Alconox provide information on cleaner residue detection by UV/Vis?

Answer:
Yes. In The Aqueous Cleaning Handbook, written by the Alconox technical support team, cleaner residue detection methods are given for each Alconox detergent. Citranox and Citrajet residues can be detected with citric acid by UV/Vis. More information can be found on the Alconox website at http://www.alconox.com/static/section_top/gen_cleanval.asp.

Ordering Samples from Alconox

Question:
How can I order samples from Alconox?

Answer:
If you wish to order samples of Alconox products please visit this page and fill out the form. You will also receive a complementary copy of The Aqueous Cleaning Handbook, a guide to critical-cleaning procedures, techniques, and validation!

Downloading Tech Bulletins

Question:
How do I download Technical Bulletins via the internet?

Answer:
Alconox provides a technical bulletin for each product. Tech bulletins are filled with information on the types of soil removed, cleaning methods, surfaces cleaned, convenient sizes, physical data, chemical description, cleaning validation methods and health and safety information.

To download technical bulletins, please visit www.alconox.com.

Bleach and Alconox Brand Products

Question:
What is the effect of adding bleach to Alconox products?

Answer:
Many of the Alconox brands including Alconox, Liquinox, Alcojet, Detojet, Detergent 8, Luminox, Solujet and Tergajet can be mixed with bleach hypochlorite for enhanced disinfection, bleaching or oxidizing properties. Alcojet and Detojet already contain an active chlorine compound. Tergajet already contains an active oxygen compound that gives peroxide oxidation performance. It may not be necessary to add hypochlorite to Alcojet, Detojet, or Tergajet.

There are other Alconox brands whose cleaning ability is negatively impacted if bleach is added. For example, adding bleach to Tergazyme will denature the enzyme and render it inactive, in fact the enzyme in Tergazyme will be inactivated within seconds to exposure of 300 ppm hypochlorite, and within 2 minutes to exposure of 3.5 ppm hypochlorite at 100 deg F (37 deg C). Thus, it is not recommended to add bleach to Tergazyme.

Citranox and Citrajet are acid cleaners and should not be mixed with hypochlorite because in sufficient quantities the mixture can form toxic chlorine gas, as they can acidify the bleach solution to below pH 7. It is not recommended to add hypochlorite to Citranox or Citrajet.

Alcotabs, Tablet Pipet Detergent, is another brand that is negatively impacted by the high pH of most bleach solutions. Adding bleach to Alcotabs can cause the pH of the solution to rise above pH 7 and prevent the effervescent - bubbling action of Alcotabs. It is not recommended to add bleach to Alcotabs.

Cleaning Brass with Citranox, Acid Cleaner and Detergent

Question:
What effect will Citranox have on brass?

Answer:
Citranox will brighten brass by removing dark copper oxides from the surface and leave a brighter, more yellow surface.

For more information on Citranox, visit here.

Alconox, Powdered Precision Cleaner Bath Life

Question:
Is it possible to prolong the bath life of Alconox?

Answer:
Yes. Start out with a stronger Alconox concentration. If using a 1% solution, use a 2% or possibly even 3% solution. After 1.5 weeks, add another 1.5% Alconox to the bath, especially if there has been make-up water added because of drag-out and evaporation. This regimen should allow successful cleaning for up to 3 weeks. It is not recommended trying to run an Alconox bath beyond 3 weeks, as these baths are prone to starting to grow microbes. Keep the bath covered when not in use and change out the bath every 3 weeks.

To view the technical bulletin and MSDS for Alconox, please visit www.alconox.com.

Critical Cleaning Applications in Medical Device Manufacturing

Question:
What product does Alconox recommend for removing oils and fingerprints from med dev surfaces prior to critical bonding operations?

Answer:
Cleaning of this kind can be accomplished by using a warm (50 deg) 1% solution of Liquinox in an ultrasonic bath followed by a purified water rinse. Detailed information about cleaning in Medical Device Manufacturing can be found in The Aqueous Cleaning Handbook 4th Edition. This 182 page book is a guide to critical cleaning procedures, techniques, and validation.

Copies of The Aqueous Cleaning Handbook 4th Edition can be obtained by visiting the Alconox website at http://www.alconox.com/static/section_customer/book.asp.

To speak to a technical representative about cleaning validation, call 914-948-4040 for Malcolm McLaughlin (x160) or email mmclaughlin@alconox.com.

Ask Alconox

Question:
How do I ask Alconox a question via the internet?

Answer:
Have questions for Alconox? We’ve got answers! Please ask our technical support team! Using the internet, visit http://www.alconox.com/section_top/m_ask.asp and you may fill out the form for specific questions or click the link to cleaning@alconox.com to e-mail general questions.

Manual Amikacin Sulphate residue removal

Question:
Which Alconox cleaners can manually remove Amikacin Sulphate?

Answer:
Amikacin Sulphate is soluble to 1.85X10E5 mg/L, contains amine functional groups and glycoside linkages therefore it is best cleaned by acid. Citranox would be the first choice. It contains glycosides links, it can probably also be cleaned by Liquinox.

Find out more about Citranox and Liquinox at www.alconox.com.

Residue Removal with Alconox brand detergents

Question:
Which Alconox brand cleaners are suitable for the removal of iron sucrose?

Answer:
Iron Sucrose is water soluble therefore it can be cleaned by either Citranox or Liquinox.

Find out more about Citranox and Liquinox at www.alconox.com.

Cleaning Eudragit L 100 -55 with Solujet in a CSP Tank (Solution Preparation Tank)

Question:
What is the correct temperature needed to successfully clean Eudragit L 100-55 with Solujet in a CSP tank (Solution Preparation Tank)?

Answer:
It is recommended to clean with 1% Solujet at 40 deg C for 20 minutes. However, if only normal temperature (20 deg C) water is available, then theoretically it will take 4 times longer because every 10 deg C you go down in temperature doubles the cleaning time needed. If at all possible, it is preferred that cleaning be done with 40 deg C solutions. It is certainly worth trying to clean longer if using hotter solution is not possible. Raising the concentration of Solujet to 2% might help a little bit, but it should not be required.

Detojet Cleaning Duration

Question:
What is the cleaning duration in a horizontal glass washer with 1% Detojet at 50 deg C?

Answer:
In house lab data that shows that one minute of contact time on a small soiled coupon of glass was completely cleaned with ~49 deg C 1% Detojet. There are machines that clean 30 to 96 inches of glass per minute. It is possible that Detojet can successfully clean at speeds on the order of 60 inches per minute. This might equate to something like 30 seconds of contact time before getting to a rinse station depending on the design of the horizontal conveyorized washer.

Chlorine added to Alconox Powdered Precision Cleaner

Question:
Will adding chlorine increase the cleaning power of Alconox Powdered Precision Cleaner?

Answer:
There is no harm in adding chlorine bleach to solutions of Alconox Powdered Precision Cleaner. Adding bleach will add oxidizing capability to the resulting solution. If the residues being removed are affected by oxidizing, then adding bleach will enhance the cleaning effectiveness. If the residues are not affected by oxidizing, then adding bleach has no effect. Adding bleach will offer some disinfecting in addition to cleaning. Note that if the full disinfection power of bleach is needed, the correct way to use it is to clean first with Alconox to remove all residues that would shield the pathogens from the bleach, and then do a second disinfection with bleach for the correct length of time in order to be sure that the pathogens have been exposed to the correct solution for the correct length of time. If you try to do these two steps together at the same time, then it is difficult to determine if the pathogens have been exposed long enough because you never know how long it takes to remove any residues that have pathogens hiding behind them.

For more information on Alconox, Powdered Precision Cleaner please visit our Technical Bulletin.

Cleaning Aluminum

Question:
How is galvanic corrosion prevented when cleaning aluminum?

Answer:
Aluminum is an active metal that is somewhat high on the "anodic index" of the galvanic series. If aluminum is cleaned with other metals present, you can create a battery and get galvanic corrosion. Aluminum should not be cleaned in the presence of metals that are significantly higher or lower on the anodic series; higher on the anodic scale such as zinc, magnesium or beryllium metals and lower on the anodic scale such as tin, brass, bronze, copper, silver, nickel and rhodium. Galvanic corrosion is facilitated between aluminum and other metals that may be dissolved in the cleaning bath from prior cleaning, or present in the cleaning bath during the time of cleaning. The corrosion can take the form of a dark grey film or deposit, a brown film or deposit, and with more exotic metals, other colors are possible. Certain cast alloys of aluminum can have galvanic corrosion problems with cast iron, carbon steel and low alloy steels. Note that intact and properly passivated stainless steel does not have a problem with galvanic corrosion on aluminum during normal cleaning.

The Alconox brand cleaners recommended for cleaning aluminum are Alconox, Liquinox, Tergazyme, Alcojet, Alcotabs, Detojet, Citranox, Luminox, Citrajet, Solujet and Tergajet. Detergent 8 is not recommended for cleaning aluminum. Aluminum that has been exposed to the environment often forms a characteristic dull grey surface oxide. None of the recommended cleaners will remove this and brighten the aluminum again. The recommended cleaners are intended for use in removing residues, not surface oxides that are bound in to the aluminum matrix. To clean this type of aluminum, there are very hazardous strong acid cleaners that can sometimes be effective. Alternatively, there are mild abrasive cleaners that can be used to polish the dark coating off the aluminum surface. Alconox does not make any of these kinds of cleaners.

Aluminum Compatibility with Alconox Cleaners

Question:
Which Alconox cleaners can be used on Aluminum?

Answer:
The Alconox brand cleaners recommended for cleaning aluminum are Alconox, Liquinox, Tergazyme, Alcojet, Alcotabs, Detojet, Citranox, Luminox, Citrajet, Solujet and Tergajet. Detergent 8 is not recommended for cleaning aluminum.

Aluminum forms a natural passive layer in air that allows it to be successfully cleaned without adverse reactions with cleaner. A passive layer forms in under an hour, provided there is no oily film present. Once the passive layer is formed, the recommended Alconox brand cleaners can be used to clean the aluminum at concentrations of less than 5% at 90 deg C or less for up to one hour. All the recommended high pH cleaners: Alcojet, Detojet, Solujet and Tergajet contain silicate corrosion inhibitors to protect the aluminum during high pH cleaning. Cleaning aluminum with a high pH cleaner above about pH 10 without a corrosion inhibitor would result in dark aluminum oxide corrosion. The protection conferred by the silicate corrosion inhibitor is a blocking of any active sites on the aluminum. These Alumino-silicates do not leave a filmy residue on the surface, whereas other types of corrosion inhibitors such as filming amines do leave behind a filmy residue. These spot alumino-silicates do not particularly change the appearance, electrical, mechanical or bonding properties of the aluminum. In the case where the aluminum did not form a passive layer, the aluminum can be attacked by cleaners. If that is the case, then it would be safest to use an acid cleaner such as Citranox or Citrajet; or a light duty neutral cleaner such as Luminox to clean the aluminum.

Pharma TOC Residue Detection Method

Question:
What is TOC and is TOC an acceptable residue detection method for Alconox Brand Aqueous Cleaners?

Answer:
Total organic carbon (TOC) is the amount of carbon bound in an organic compound and is often used as a non-specific indicator of water quality or cleanliness of pharmaceutical manufacturing equipment. A typical analysis for TOC measures both the total carbon present as well as the inorganic carbon. Subtracting the inorganic carbon from the total carbon yields TOC. The United States Pharmacopoeia recognizes TOC as a required test for purified water and water for injection. For this reason, TOC has found acceptance as a process control attribute in the biotechnology industry to monitor the performance of unit operations comprising purification and distribution systems. As many of these biotechnology operations include the preparation of medicines, FDA enacts numerous regulations to protect the health of the public and ensure the product quality is maintained. To make sure there is no cross contamination between product runs of different drugs various cleaning procedures are performed. TOC concentration levels are used to track the success of these cleaning validation procedures especially clean-in-place (CIP).

TOC analysis has been reported to detect the organic surfactants present in ALCONOX (11% w/w), LIQUI-NOX (21% w/w), TERG-A-ZYME (11% w/w), ALCOJET (1.5% w/w), ALCOTABS (20% w/w), DETERGENT 8 (38% w/w), LUMINOX (26% w/w) CITRANOX (17% w/w), CITRAJET (14% w/w), TERGAJET (10.5% w/w) and SOLUJET (6% w/w). You must go through the acid neutralization step or use the inorganic carbon channel on the TOC analyzer to account for inorganic carbon.

For more information, Ask the Alconox Critical Cleaning Experts! Visit here to ask a questions.

Validation Support

Question:
Does Alconox provide cleaning validation tech support?

Answer:
Alconox, Inc Technical Support welcomes the opportunity to assist our customers in validating Alconox brand cleaners. In fact, Alconox Technical Support has written Cleaning Validation References specifically to help with residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, methods validation and recovery studies, and writing a procedure and training operators. A downloadable version of the Cleaning Validation References is available here.

Cleaning validation literature can also be requested through postal mail by visiting here.

Also, if you have a specific question concerning cleaning validation "Ask Alconox" by visiting here.

To speak with a cleaning validation expert directly, call 914-948-4040 extension 160 for Malcolm McLaughlin or email at mmclaughlin@alconox.com

Pharma Critical Cleaning and 21 CFR 211.67

Question:
Why is critical cleaning necessary for the pharmaceutical industry? Are Alconox brand cleaners formulated to be used in the pharmaceutical industry?

Answer:
All pharmaceutical products, prescription and over-the-counter, available for use in the U.S. must be produced according to the FDA's cGMP regulations. These guidelines are in accordance with Finished Pharmaceuticals (human and animal products): Title 21 CFR 210 and 21 CFR 211.

§ 211.67 Equipment cleaning and maintenance.

a) Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

(b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following:

(1) Assignment of responsibility for cleaning and maintaining equipment;

(2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules;

(3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance;

(4) Removal or obliteration of previous batch identification;

(5) Protection of clean equipment from contamination prior to use;

(6) Inspection of equipment for cleanliness immediately before use.

(c) Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in §211.180 and §211.182.

Alconox offers a range of pharmaceutical grade critical cleaners.

Alconox brand cleaners are widely used in the pharmaceutical industry because they easy to validate, leave no interfering residues on hard surfaces, are biodegradable and readily disposable. Moreover, a multi-product pharmaceutical manufacturing plant with multi-cleaning needs can often find a single Alconox brand aqueous cleaner for all needs, resulting in reduced cost. All Alconox brands are GMP compliant and have downloadable lot specific Certificate of Analysis (COA), MSDS, Technical Bulletins, Trace Analysis. Alconox Critical Cleaning Experts have written Pharmaceutical Cleaning Validation References that includes a Directory of Cleaner Residue Detection Methods for each Alconox Detergent. To download your free copy please visit here.

Medical Device Cleaning

Question:
What classes of medical devices are Alconox brand cleaners formulated to clean?

Answer:
Alconox brand cleaners are formulated to clean Class I, II, and III medical devices. For further information please visit the Alconox website at http://www.alconox.com/static/section_customer/ind_meddev.asp.

According to www.fda.gov, the FDA classifies medical devices into three categories. Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user. Class II are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. Special controls may include special labeling requirements, mandatory performance standards and post market surveillance. Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

ISO Certification

Question:
What is ISO 9000? Can Alconox brand cleaners be used by companies with ISO 9000 certification?

Answer:
ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies.

Alconox brand cleaners are GMP compliant and are often used by companies with ISO 9000 certification.

GHTF

Question:
What is the GHTF?

Answer:
Directly taken from www.GHTF.org, The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework. The purpose of the GHTF is to encourage convergence in regulatory practices related to ensuring the safety, effectiveness, performance and quality of medical devices, as well as promoting technological innovation and facilitating international trade. The primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices.

In this regard, Alconox aqueous cleaners are formulated to scrupulously clean medical devices to help manufacturer meet specified regulations, for more information please visit http://www.alconox.com/static/section_customer/ind_meddev.asp.

ICH

Question:
What is the objective of the ICH?

Answer:
According to www.ICH.org, The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

The objective of ICH is to increase international harmonisation of technical requirements to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost-effective manner. These activities have been undertaken to promote public health, prevent unnecessary duplication of clinical trials in humans, and minimize the use of animal testing without compromising safety and effectiveness.

In this regard, keeping manufacturing equipment clean is necessary to avoid cross contamination. To ensure safety requirements are met and to maintain a high standard of quality for products, many pharmaceutical manufacturers use Alconox brand products for critical cleaning. Learn more about Alconox aqueous cleaners and validation support offered by Alconox critical cleaning experts! Visit www.alconox.com for more information.

Cleaning Validation Information

Question:
What is a definition of cleaning validation? Does Alconox provide cleaning validation support for Alconox brand cleaners?

Answer:
Cleaning Validation - Documented evidence with a high degree of certainty that a cleaning process will consistently produce product meeting its predetermined quality attributes. Quality attributes are typically those related to potentially contaminating residues.

Alconox, Inc provides validation support on all Alconox brand cleaners to assist in meeting cGMP guidelines. In fact, Alconox, Inc technical team has written The Aqueous Cleaning Handbook, and has dedicated chapters to Cleaning Validation (Chapter 8) and to Measuring Cleanliness (Chapter 10). For more information or get your free copy of The Aqueous Cleaning Handbook visit, http://www.alconox.com/section_customer/book_info.asp.

Calculating Cleaning Agent Safety Based Limits

Question:
Does Alconox provide information on calculating cleaning agent safety based limits?

Answer:
Alconox, Inc Pharmaceutical Cleaning Validation Method References has an entire section dedicated to cleaning agent safety based limits. Please visit here for more information: http://www.alconox.com/static/section_top/gen_cleanval.asp.

Cleaning agent safety based limits are typically calculated from a safety factor of an acceptable daily intake (ADI), a (1/1000 or more) reduction of an LD50 preferably by the same route of administration, or reproductive hazard levels. If the calculated limit is found to be higher than a less than 10 ppm carryover to the next batch, then the limit can be set to the more stringent 10 ppm carryover level for the safety based limit.

For additional information, the Alconox Technical Team has also written The Aqueous Cleaning Handbook, which in Chapter 10 discusses Measuring Cleanliness. For more information on the Handbook visit http://www.alconox.com/section_customer/book_info.asp.

Electronics Cleaning with no Hazardous Chemicals or Volatile Solvents

Question:
Why is it beneficial to use Detergent 8 when cleaning circuit boards and electronic components?

Answer:
Detergent 8 contains no conductive metal cations, and therefore it cannot leave conductive residues. Its coupling ability keeps soils suspended in the cleaning solution, not on the circuit boards. If the solution is promptly washed away with deionized water, boards will meet the omega-meter or ionograph standards of cleanliness. Detergent 8 can be used in a variety of electronic applications, such as, cleaning glass substrate before dichloric coating of electronic parts, cleaning during manufacturing and assembly, cleaning electronic contacts and leads as well as ceramic insulators and components.

Detergent 8 can be used manually, soak or spray. For more information please visit http://www.alconox.com/downloads/pdf/techbull_detergent8.pdf.

For more on cleaning electronics, please visit Alconox website at http://www.alconox.com/static/section_customer/ind_electronics.asp.

ar Reactor Cavity and Equipment Decontamination

Question:
What cleaner does Alconox recommend for the decontamination of nuclear reactor cavities and related equipment?

Answer:
Alconox recommends Detergent 8, a non-ionic, phosphate-free homogeneous blend of an alkanolamine, glycol ethers and an alkoxylated fatty alcohol for decontaminating nuclear reactors and related equipment including pipes, tools, and protective equipment. It contains no chelating agents or halides, or conductive metal cations. It is imperative to avoid detergents containing chelating agents as they can bond chemically to radioisotopes. Also it is important to avoid detergents containing fluorides, chlorides, or sulfur ingredients which might cause surface corrosion or intergranular stress corrosion of stainless components.

If the key concern is avoiding waste interference, then Detergent 8 is the brand to use. Detergent 8 can be used manually, soak or spray. For more information please click here.

Use Alconox brand products in the nuclear industry! Visit our website.

Alconox Brands for Ultrasonic Tank Cleaning

Question:
What is ultrasonic tank cleaning? Which industries commonly employ the method? What Alconox, Inc brands would be ideal for ultrasonic tank cleaning?

Answer:
Ultrasonic Tank cleaning works best on objects or part that are made of stainless steel, mild steel, aluminum, copper, brass, other alloys, plastic or rubber. The object to be cleaned is placed in a chamber containing a suitable ultrasound conducting fluid such as an aqueous cleaner depending on the application. Aqueous cleaners typically contain surfactants that reduce the surface tension of the water. An ultrasound generating transducer is built into the chamber, or may be lowered into the fluid. It is electronically activated to produce ultrasonic waves in the fluid. The main mechanism of cleaning action is by energy released from the creation and collapse of microscopic cavitation bubbles, which break up and lift off dirt and contaminants from the surface to be cleaned. The higher the frequency, the smaller the nodes between the cavitation points which allows for more precise cleaning.

Industrial ultrasonic cleaners are used in the automotive, printing, marine, medical instruments, medical device manufacturing, electroplating, and weapons industries.

Liquinox, critical cleaning liquid detergent, is a high emulsifying cleaner that is an excellent product for use in soak and ultrasonic cleaning. Citranox, acid cleaner and detergent, is also a high-emulsifying cleaner ideal for metal oxides and deposits.

Technical Bulletins and MSDS for each are downloadable from www.alconox.com or

• Liquinox Tech Bulletin: http://www.alconox.com/downloads/pdf/techbull_liquinox.pdf


• Liquinox MSDS: http://www.alconox.com/static/msds/msds_liquinox.asp


• Citranox Tech Bulletin: http://www.alconox.com/downloads/pdf/techbull_citranox.pdf


• Citranox MSDS: http://www.alconox.com/static/msds/msds_citranox.asp

Alconox Brands for Clean-In-Place (CIP) Systems

Question:
What Alconox brand cleaners are recommended for Clean-In-Place (CIP) systems? What information does Alconox offer to assist in validating CIP cleaners?

Answer:

It is desirable to use a low foaming cleaner that rinses freely in a CIP system. Selecting the appropriate CIP cleaner will be determined by the type of soil being removed as well as the hard surface being cleaned. Alconox, Inc manufacturers' several low foaming liquid cleaners that work well in CIP, including Solujet, an alkaline cleaner, and Citrajet, an acidic cleaner. An alkaline cleaner best removes oils, fats, grease and an acidic cleaner works best to remove insoluble hydroxides and metal oxides. Both Solujet and Citrajet are suitable to use on stainless steel manufacturing surfaces.

• Technical Bulletins and MSDS for each are downloadable from www.alconox.com
  
• Solujet Technical Bulletin: http://www.alconox.com/downloads/pdf/techbull_solujet.pdf
• Solujet MSDS: http://www.alconox.com/static/msds/msds_solujet.asp
• Citrajet Technical Bulletin: http://www.alconox.com/downloads/pdf/techbull_citrajet.pdf
• Citrajet MSDS: http://www.alconox.com/static/msds/msds_citrajet.asp

Alconox, Inc provides assistance to validate cleaners for CIP systems. Information on residue detection methods for Solujet and Citrajet can be found at http://www.alconox.com/static/section_top/gen_cleanval.asp.

Pharma Clean In Place (CIP) and Standard Operating Procedures (SOPs)

Question:
What is clean in place (CIP)? What are four reasons the pharmaceutical industry commonly employs clean in place (CIP) systems? Does Alconox, Inc have information on CIP Standard Operation Procedures (SOPs)?

Answer:
CIP stands for Clean-In-Place and is a method of cleaning the interior surfaces of closed systems and process equipment without dismantling the equipment. There are different types of CIP including, single pass systems and recirculation system.
The pharmaceutical industry heavily relies on clean in place (CIP) system because operators are not required to enter plant to clean, difficult to access areas can be cleaned, production time between production runs is minimized, and recycling the cleaner can reduce cost. Equipment used in pharmaceutical manufacturing must be cleaned before each use, and the cleaning procedure used must be in accordance with good manufacturing practices (GMPs). Alconox provides support to meet cGMP regulations. In fact, Alconox, Inc technical team has written The Aqueous Cleaning Handbook, where Standard Operating Procedures for CIP systems are discussed (see Chapter 7). For more information or get your free copy of The Aqueous Cleaning Handbook visit, http://www.alconox.com/section_customer/book_info.asp.

Alconox, Inc Provides Pharma Cleaning Validation Support

Question:
What is pharmaceutical cleaning validation? What information can Alconox, Inc provide to support pharmaceutical cleaning validation?

Answer:
Cleaning validation is the methodology used to assure that a cleaning process removes any residues of the active pharmaceutical ingredients (API) of the product manufactured, as well as any residual cleaning agent utilized in the cleaning process and any microbial contaminants on the surface of the manufacturing equipment or utensil. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product.

Alconox, Inc provides validation support to help meet pharmaceutical cGMP requirements. Alconox, Inc Technical Team has written Pharmaceutical Cleaning Validation References that includes a directory of cleaner residue detection methods for each Alconox brand. Also to help comply with cGMP regulations all cleaner brands have traceable lot specific certificate of analysis (COA), Technical Bulletins and MSDS.

Alconox, Inc Support Pharma Manufacturers with CFR-Part 211.67

Question:
What is 21 CFR-Part 211.67? How can Alconox, Inc help pharmaceutical manufacturers meet these requirements?

Answer:
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published by the Government Printing Office (GPO) in the Federal Register (FR) by the Executive departments and agencies of the Federal Government. The FDA regulatory guidelines specifically for Title 21 CFR-Part 211.67 details the FDA clean standards on Equipment Cleaning and Maintenance. For more details visit, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67.

The Alconox technical support team has developed a guide for cleaning validation to help the pharmaceutical manufacturer meet these standards. The cleaning validation involves residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, methods validation and recovery studies, and finally writing a procedure and training operators. This procedure is used to document acceptable residues three or more times and then establish a rational monitoring program that verifies that the validated state is being maintained. For more information please visit the Alconox website at www.alconox.com/static/section_top/gen_cleanval.asp.

MD&M East 2008, Alconox Booth #2266

Question:
Will Alconox, Inc attend the MD&M East Show in 2008?

Answer:
Alconox, Inc will be attending the MD&M East Show at the Jacob Javits Center New York City, NY on June 3-5. Stop by our booth #2266 for your free copy the Guide to Critical Cleaning or Aqueous Cleaning Handbook!

You'll want to visit Alconox, Inc booth #2266 at MD&M EAST because...

Alconox, Inc is The Leader in Critical Cleaning Detergents with sixty years of experience getting medical equipment critically clean for use in demanding human or veterinary health applications, and in the manufacturing of medical devices - such as titanium prosthetic hip joints - we understand how to clean to implantable standards. Whether the product is designed for in vitro or in vivo use, is biomechanical or electronic, you'll find an Alconox cleaner expressly formulated to get products scrupulously clean without leaving interfering residues.

You'll meet the Alconox, Inc technical experts who are ready to discuss your cleaning validation needs!

MD&M is the recognized resource since 1983 for everything you need to design and manufacture medical devices and equipment for today's increasingly competitive healthcare marketplace. For more information please visit this website: http://www.devicelink.com/expo/east07/.

Interphex2008, Alconox Booth #107

Question:
Will Alconox, Inc attend the INTERPHEX2008 Pharmaceutical Manufacturing Conference and Exhibition?

Answer:
Alconox, Inc will be attending the INTERPHEX2008 Pharmaceutical Manufacturing Conference and Exhibition at the Pennsylvania Convention Center - Philadelphia, PA March 26-28, 2008. Stop by our booth #107 for your free copy the Guide to Critical Cleaning or Aqueous Cleaning Handbook! Great opportunity to "Ask Alconox" and get experts advice about your industrial cleaning needs! Mark your calendars for INTERPHEX2008 Pharmaceutical Manufacturing Conference and Exhibition!

INTERPHEX is the world's most trusted source for leading-edge technology, education, and sourcing of the products and services that drive scientific innovation for Life Sciences manufacturing from drug development to market - accelerating regulated products for patient care globally.

INTERPHEX is the only Life Sciences event that represents a true cross-section of the pharmaceutical and biopharmaceutical industries. Industry-leading professionals worldwide make INTERPHEX the industry's annual focal point for driving change and efficiencies for the global pharmaceutical and biopharmaceutical market.
INTERPHEX will once again feature the co-location of PharmaMedDevice, the only comprehensive event to focus on the convergence of medical device, pharmaceutical, and biologic industries.

For more information about INTERPHEX, please click here.

Interphex Puerto Rico 2008, Alconox Booth #39

Question:
Will Alconox, Inc attend the INTERPHEX Puerto Rico 2008 Pharmaceutical Manufacturing Conference and Exhibition?

Answer:
Alconox, Inc will be attending the INTERPHEX Puerto Rico 2008 Pharmaceutical Manufacturing Conference and Exhibition at the Puerto Rico Convention Center, San Juan on February 14-15, 2008. Stop by our booth #39 for your free copy the Guide to Critical Cleaning or Aqueous Cleaning Handbook! Great opportunity to "Ask Alconox" and get expert advice about your industrial cleaning needs! Mark your calendars for INTERPHEX Puerto Rico 2008 Pharmaceutical Manufacturing Conference and Exhibition!

INTERPHEX Puerto Rico is the pharmaceutical industry's respected source of innovation, education, and professional advancement for a globally important center of drug manufacturing, from process development through delivery to market. Networking essential to business success is as important here as the exploration of new products and services that enhance human life and health.

For more information on INTERPHEX, please click here.

Sustainable, Safe, and Reduced Wasted Cleaning Processes

Question:
Is it possible in today's manufacturing environments to use safe, clean, reduced wasted cleaning processes that are ultimately sustainable?

Answer:
Yes it is possible in today's manufacturing environments to employ sustainable, safe, clean, and reduced wasted cleaning processes! The first step in evaluating the environmental health and safety of an aqueous cleaner is to secure the material safety data sheet and technical bulletins for the cleaners you plan to test or use, and to assemble as much information as you can about the soils you will be removing. A review of this information should disclose important environmental and health hazards as well as regulations.

When performing an initial review of regulations for an aqueous cleaner, it is important to consider Occupational Safety and Health Administration (OSHA) regulations, National Pollutant Discharge Elimination System (NPDES) discharge permits, Department of Environmental Protection (DEP) sewer connection/extension permits, and any Resource Conservation and Reclamation Act (RCRA) hazardous waste class or Clean Water Act regulations. State and local environmental regulations should also be considered.

It is wise to conduct a full scale environmental audit no matter what type of cleaning system you are using. Such an audit may result in changes in the way you currently manufacture and clean. In fact, after conducting a full-scale environmental audit many companies turn to aqueous cleaning achieve regulatory compliance easily and safely. A program of regular re-auditing can assure continued regulatory compliance.

Compared to hazardous nonaqueous and semiaqueous cleaners-particularly, those containing ozone-depleting fluorocarbon solvents, carcinogenic organic solvents, and/or flammable components-aqueous cleaners are good choices for safe, environmentally sound cleaning. By choosing high quality, environmentally sound aqueous cleaners, most cleaning problems can be solved without endangering workers or the environment.

Safety Issues in Aqueous Cleaning

Question:
What are the safety issues involved in aqueous cleaning?

Answer:
Worker safety issues, for aqueous cleaners, involve skin exposure, eye exposure, ingestion, inhalation, and chronic systemic exposure. Consult the label and material safety data sheet on the cleaner for warnings and safety precautions.

When cleaning by hand, it is always good practice to wear protective gloves. Even the mildest cleaners can sometimes cause "dishpan-hands". Gloves also provide protection and comfort when working, by hand, with hot solutions. In fact, many highly acidic or alkaline cleaners require the use of chemical-resistant gloves for worker safety. Eye exposure is also a concern with many aqueous cleaners.

Eye tissue is particularly vulnerable to attack by chemically active aqueous solutions. Accordingly, it is also considered good industrial practice to wear safety glasses or other eye protection when working with aqueous-cleaning solutions. Particularly hazardous aqueous cleaners should have warnings and recommended eye protection on the label.

In addition, there may be inhalation hazards with some aqueous cleaners. Because aqueous cleaners generally do not have volatile solvent ingredients, it is somewhat unusual to find the need for respiratory protection with such cleaners. However, it is considered good industrial practice to have some respiratory protection when working with sprays and mists in open-spray cleaning. Any special ventilation required should be noted on the material safety data sheet. Some semiaqueous cleaners may contain volatile solvents that require special ventilation and possibly even flammability controls.

While it is relatively unusual for an aqueous cleaner to contain any carcinogenic ingredients, the cleaner's material safety data sheet should disclose any long-term chronic exposure concerns relating to carcinogenicity.

Physical safety issues with aqueous cleaners, generally, concern storage and handling to avoid any hazardous reactions with other industrial chemicals. Good industrial practice usually involves storing acid and alkaline chemicals separately to avoid any reactions between them in the event of accidental spills. Some aqueous cleaners contain bleaches or other oxidizing agents that should be stored away from reactive chemicals that might undergo hazardous oxidation reactions. As previously mentioned, most completely aqueous cleaners are not flammable. However, some aqueous cleaners contain ingredients that form hazardous chemicals when burned. (It is considered good practice to wear respiratory protection when fighting any fire involving industrial chemicals.)

Cleaning Machined Plastic Implants

Question:
After machining plastic implants, what is the recommendation for an in process cleaning using a small ultrasonic tank?

Answer:
The recommendation would be to use 1% Liquinox (a mild alkaline, emulsifying and dispersing cleaner) at a temperature well within the temperature tolerance of the plastic. Warm solutions clean faster than ambient temperature ones, so if some heat is an option, use it. Liquinox would not harm plastics other than possibly stressed polycarbonate where there is potential for stress cracking. Stressed polycarbonate in the presence of heat and low surface tension solution (like a solvent or a detergent) will undergo stress cracking (fogging or crazing). Very dilute (0.25%) solutions of Liquinox used without heat can usually safely clean even stressed polycarbonate without problems - of course hopefully the polycarbonate is not that dirty because of course a 0.25% solution does not clean as well as the typical 1% solution.

Aqueous Cleaning and Environmental Issues

Question:
What are environmental issues are involved with aqueous cleaning?

Answer:
Generally, the environmental issues involved in aqueous cleaning have to do with the ingredients used and their ultimate discharge into the environment. Taking a larger view, it is also important to consider the energy and resources consumed in making and using the cleaner.

There are several important factors concerning discharge of spent cleaning solutions into the environment: biodegradability, aquatic toxicity and eutrophication acceleration. Early detergent formulations contained poorly biodegradable surfactants
that often caused foaming of lake and river surfaces after spent solutions were discharged to drain. All modern detergent formulations use biodegradable surfactants that do no buildup or persist in the environment causing foaming problems.

Aquatic toxicity can come from very high or very low pH or from toxic ingredients. Where extreme pH cleaning is required, it is advisable to neutralize or discharge spent solutions in small enough quantities to avoid problems. The surfactants in aqueous cleaners may be a source of aquatic toxicity. The use of biodegradable surfactants and the discharge of limited quantities of cleaning solutions generally results in safe concentrations of surfactants on water surfaces. Older, more highly toxic surfactants are rarely used in aqueous cleaner formulations.

Eutrophication involves cleaners that contain phosphates. Phosphorus is an essential nutrient for algae. When significant amounts of phosphorus are discharged into surface water, vigorous algae blooms may result. The algae die and settle to the bottom filling lakes and ponds with silt and organic matter more rapidly that normal. Although eutrophication is a normal, natural process, the acceleration of this process by phosphates is undesirable. The main source of phosphorous in surface waters is agricultural run-off from farming. There are no national regulations restricting the use of phosphates in cleaners, however, many states and municipalities have enacted legislation that restricts the use of phosphates in household cleaners. There are currently no restrictions on the use of phosphate containing cleaners in industrial cleaning applications.

Aqueous Cleaning Environmental Health and Safety Issues

Question:
What are the environmental health and safety issues that need to be considered when developing an aqueous cleaning process?

Answer:
Aqueous cleaners, by definition, use water for cleaning and rinsing. This has both advantages and disadvantages. Water is an inherently environmentally sound and substantially safe chemical to work with. It is a recyclable natural resource. Yet, as populations grow, clean surface water will become increasingly scarce. Water can also be a transport medium for various polluting or hazardous chemicals that may derive from the use of aqueous cleaning in specific instances.

One way to look at the environmental health and safety of a cleaning process is to consider:

• How hazardous is the cleaning process?
• How hazardous is the effluent resulting from the cleaning process?
• How sustainable-in terms of energy and resources-is the process?

All critical cleaning falls within a safety continuum. At one end are the polluting, hazardous processes; at the other, those that are to clean and safe processes; clean, safe, sustainable and produce little waste. Aqueous cleaning may fall anywhere along this continuum.

Of course, some aqueous cleaners do contain hazardous ingredients that may be used to clean hazardous soils, which may produce hazardous and polluting waste. But by the same token, industrial cleaning may involve the use of an aqueous cleaner with no hazardous ingredients used to clean the same hazardous soil, resulting in a clean and relatively safe process.

Improvement in safety can be achieved by eliminating the source of the hazardous soil in the process. Going a step further, waste can be reduced by integrating soil recycling, cleaning solution recycling and/or rinse water recycling into the cleaning process. It is possible to design a so-called "zero-discharge" system with no fluid effluent, limited volatile effluent and reduced solid waste by recycling cleaning and rinsing solutions using filters. In order to move toward a clean, safe and sustainable process, however, one would need to eliminate the hazardous soil and replace it with a non hazardous biodegradable soil. Then, after the water used in the cleaning and rinsing process has been recycled sufficiently, for energy efficiency, the now nonhazardous soil in the effluent would not pose no environment threat. Any water released could safely be incorporated into the natural water cycle (surface water evaporates to form clouds, which later precipitate as rain, and return as surface water).

It is, generally much more difficult to clean safely and sustainably using nonaqueous cleaning methods. Many nonaqueous cleaners are themselves health hazards, water pollutants, or air pollutants. Certainly not all nonaqueous cleaners are hazards and/or pollutants, but most lack a basic natural means, such as the water-cycle, of purifying and/or recycling key ingredients. Of course, this is an oversimplification. Given enough time, almost anything can complete a natural cycle of synthesis and decay. However, here, we are considering processes achievable in the course of a human lifetime.

One might argue that the carbon cycle, the nitrogen cycle, the oxygen cycle and other elemental cycles are involved in the decomposition and purification of ingredients used in nonaqueous cleaners. In fact, some of these cycles are also involved in the purification of ingredients found in aqueous cleaners but to a lesser degree. All of the cycles, noted above, involve multiple chemical transformations. They are slow processes in which chemicals may remain in one state for many years before degrading to a purer form. For example, during the nitrogen cycle, nitrogen remains in the air typically for years. Likewise, carbon takes the form of geological carbonates for extensive periods of time during the course of the carbon cycle, in some cases for millennia. Oxygen also remains tied up in the form of geological carbonates. These elements simply do not cycle rapidly, to a pure state, the way water does.

Cleaning Salicylic Acid

Question:
What can be used to manually clean lotions, creames, emulsions containing salicylic acid from manufacturing equipment?

Answer:
In general salicylic acid is best cleaned by sodium phosphate or alkali citrate salt containing cleaners. Creams and lotions are often best cleaned by high alkaline cleaners. Alconox powder is moderately alkaline sodium phosphate containing cleaner that is somewhat safer for manual use than some high alkaline cleaners. Alconox is a powder and some companies may much prefer a liquid. Alconox would work well here and would be better than Liquinox for this application. If the customer prefers a liquid, I would recommend either Detojet or Solujet. Note that Detojet and Solujet are both hazardous corrosive liquids that require skin and eye protection for handling. Solujet and Detojet must ship on non-passenger aircraft and can only be air shipped in the 5 gallon (19 L) size.

Cleaning Agent Environmental Considerations

Question:
What are some environmental considerations when selecting a cleaning agent?

Answer:
Environmental considerations include concern over volatile solvents with ozone-depleting potential and volatile-organic compound content that is regulated by The Clean Air Act Amendments. Any detergent chosen should be biodegradable and readily disposable, and contain no RCRA Hazard Classification or EPA Priority Pollutants.

Surfactants are not generally viewed as a menace to the environment. Nonetheless, their impact on the environment often receives as much attention as their technical properties and economic aspects. One reason may be that the mental image most people have of foaming streams and rivers, formed over three decades ago, has not faded entirely. This foam resulted from non or poorly biodegradable surfactants which are no longer used in modern aqueous cleaner formulations.

Then too, public environmental awareness has increased markedly in recent years. Some might say that, environmentalism has transcended its position as a mere social attitude to become a moral imperative. Many of us want to "do the right thing," environmentally speaking. To this end, regulations are enacted and new products designed and marketed. In the age of environmental marketing and awareness, we form perceptions regarding effects of new products on the environment, often, without complete scientific evidence. More comprehensive consideration of the total cost of environmentally negative practices, can lead to a realization that the most environmental choice can also be the best choice from an economic standpoint. When sustainable, environmental practices and choices of cleaning agents and cleaning techniques are integrated into normal practices without having to be specially labeled as environmental practices, but rather as best practices, they will be most successful.

Clean a Microfiltration Membrane System

Question:
Can Tergazyme be used to clean a microfiltration membrane system? Can Tergazyme be a supplement to bleach cleaning.

Answer:
Tergazyme can be an excellent pre-cleaning procedure prior to bleaching. Tergazyme can break down hydrophobic biofilms and other residues that can interfere with bleach performance.

Health and Safety Considerations with Cleaning Agents

Question:
What are health and safety considerations when selecting and using a cleaning agent?

Answer:
Human health and safety considerations include detergent toxicity, corrosivity, reactivity, and flammability. These considerations can be evaluated by reviewing a Material Safety Data Sheet for the solvent, chemical, or detergent with which you intend to clean. The detergent(s) you choose for your application preferably should:

• be formulated to minimize health-safety concerns while still offering outstanding cleaning performance
• not contain any hazardous ingredients listed on the OSHA standard and Hazardous Substance List 29CFR1910 subpart Z
• not have flash points or stability hazards.

Many detergents strong enough to remove fingerprints can remove oils from skin and, therefore, have the potential to dry out skin and cause "dishpan hands." This is especially true of detergents designed for machine spray washing which, in order to perform in the limited contact time afforded during spray cleaning, are considered to be aggressive cleaners.

Protective neoprene, butyl, rubber, or vinyl gloves are recommended for any extensive manual cleaning operation. In addition, many detergents are potential eye irritants, and should not be used without eye protection.

Alconox, Inc has downloadable MSDS at www.alconox.com for each brand of cleaner.

Aqueous Cleaning Consideration Questions

Question:
What are important questions to consider when selecting an aqueous cleaner?

Answer:
Today's aqueous critical-cleaning detergents are blended for specific applications-substrate, degree of soil load, and cleaning process-these, are all important considerations when selecting a detergent. Here are a few questions to ask about a detergent brand to ensure that it meets your specific cleaning needs:

1. Does it have good detergency on the types of soils that you need to remove? A broad range of organic and inorganic soils are readily removed by mild-alkaline cleaners that contain a blend of surfactants and sequestering agents. Metallic and inorganic soils are often readily solubilized by acid cleaners. Proteinaceous soils are effectively digested by protease enzyme cleaners.

2. Is it free-rinsing? Will it rinse away without leaving interfering detergent residue? A properly formulated detergent will contain rinse aids to help the rinse water remove the detergent and soil solution. Rinsing is a critical part of high-performance cleaning. The detergent usually loosens all the soil from the surface and then the rinse water sweeps it away. Use a non depositing nonionic rinse aid. Many rinse aids are cationic positively charged compounds that are attracted to a surfaces that repel the water, this can leave a surface covered with the water repelling rinse aid.

3. Is the detergent recommended for the desired cleaning method? Use low foam cleaners for high agitation cleaning (pressure spray wash, dishwasher, etc. ). Use high foam cleaners for immersion or soaking (manual, ultrasonic, etc.).

4. How hazardous is it? For example, is it highly alkaline or acidic, presenting a personal health hazard? Is it corrosive? Does it present a reactivity hazard with soils? Is it a flammable or volatile solvent? These considerations can be evaluated by reviewing a Material Safety Data Sheet for the agent. Preferably, it should not contain any hazardous ingredients listed on the OSHA standard and Hazardous Substance List 29CFR 1910 subpart Z.

5. Can it be disposed of easily? Any detergent chosen should be readily disposable and biodegradable, containing no RCRA Hazard Classification or EPA Priority.

6. Is it environmentally friendly? Considerations include ozone depletion potential and volatile organic compound (VOC) content regulated by the Clean Air Act Amendments. Approval under anticipated future restrictions should be weighed as well.

7. How economical is it? The detergent should be widely available and affordable. For optimal economy, a concentrated detergent is typically used at 1:100 dilutions.
In choosing an appropriate detergent, one must consider the equipment being cleaned, the cleaning method, the degree of cleanliness and residue removal that are necessary and the performance of the detergent. Key questions to ask about selecting a cleaner are:

- Does it have fillers? There are a number of ways to tell whether the powder or liquid brand you're considering contains excess fillers or is optimally concentrated.

- What are the ingredients?

Powders: When selecting a powdered brand, look at the label, technical bulletins, and MSDS to see if it contains any sodium chloride or sodium sulfate compounds which do not perform a useful cleaning function but merely add to volume and weight (and shipping costs).

Liquids: With liquid detergents, the most common filler is water. It is important, however, that no more water is used than necessary to ensure a good solution, maintain stability, and prolong shelf life.

- What is the concentration?
Powders: It is rare that a detergent will require more than a 1 percent solution of detergent to water (1:100) for good detergency. For long bath life, in some cases higher concentrations up to 3 or 4 percent are acceptable.

Liquids: Typically, an alkaline cleaner will not require a dilution greater than one percent (1:100). Whereas, a semi aqueous or solvent-containing cleaner may require a dilution of two percent (2:100) or more. Again, for long bath life, higher concentrations are acceptable.

- What are the operating costs? Operating costs for aqueous cleaners are generally low since these cleaners are usually concentrated-typically using only one to five percent of cleaner solution to water. In addition, aqueous cleaning baths last a relatively long time without recycling.

Strong acid cleaners generally require constant system maintenance since their aggressive chemistry can attack tank walls, pump components, and other system parts as well as the materials to be cleaned. (Inhibitors can be used to reduce such attack.) Another disadvantage of strong acid cleaners stems from soil loading-particularly metal loading-which requires frequent decanting and bath dumping, leading to relatively high operating costs compared with alkaline cleaners.
In contrast, alkaline cleaners are often more economical compared to acid chemistries, because they do not cause excessive maintenance problems.

Cleaning Semiconductors

Question:
Which cleaner is best for removing alcohol and other outgassing residue from storage of semiconductors and related high purity components in plastic bags?

Answer:
Semiconductors and related high purity precision manufacturing components are sometimes stored in bags during processing. Those bags can sometimes have plasticizers, plasticizer residues, or residues of cleaners used to clean the bags. To remove those residues you need either a good high emulsifying cleaner or a good solvating cleaner. For immersion cleaning, it is more efficient to use an emulsifying cleaner if that cleaner is compatible with your semiconductor substrate. Many emulsifying cleaners contain metal salts, particularly sodium salts that would be incompatible with many silicon semiconductors. If you are cleaning less sodium sensitive semiconductors then you can use a high emulsifying cleaner like Liquinox to remove organic residues such as alcohols and alcohol derivatives such as cleaner or plasticizer residues from plastic bags. Typically you might ues a warm 1% solution of Liquinox in a soak or ultrasonic tank. If you cannot tolerate sodium residues, then you would use a cleaner that relies on solvation like Detergent 8. Detergent 8 does not contain sodium. Of course since solvation is a less efficient process than emulsifying, you have to use higher concentrations of Detergent 8 to achieve cleaning. Typically you would use a 3-5% concentration of Detergent 8 to soak or ultrasonic clean with.

Aquatic Toxicity

Question:
What is the aquatic toxicity of the surfactant in Liquinox?

Answer:
In order to evaluate proper disposal in compliance with some local regulations, you sometimes need to know the aquatic toxicity of detergents that you might wish to dispose of in to a locally regulated sewerage treatment plant. Liquinox, Alconox, Tergazyme, Citranox, and Alcotabs all contain roughly 5-20% sodium dodecylbenzene sulfonate surfactant. The aquatic toxicity for sodium dodecylbenzene sulfonate for Phoxinus phoxinus minnow is an LC50 of 5,633 ug/L (lethal concentration for 50% of the population). Using this information, knowing how much detergent you plan to discharge you can determine the concentration of surfactant and what the contribution to aquatic toxicity from the surfactant will be and if it meets the local discharge limits. Typically with normal amounts of detergent discharge, you will find that it is acceptable to discharge the detergent in accordance with your local regulations.

Total Organic Carbon

Question:
How much Total Organic Carbon (TOC) is in Alcojet and Citrajet?

Answer:
Alcojet contains 1.5% (w/w) Total Organic Carbon. This means that in 100 g of Alcojet there is 1.5 grams of TOC. In terms of concentration, this means that a 1% solution of Alcojet (10 g Alcojet/L) would contain 0.15 g TOC/L (10 g Alcojet * 0.015 g TOC/g Alcojet). Note that there is substantial IC content in Alcojet (just roughly estimating in my head without calculating precicely, there is around 10% IC in Alcojet). This means you must adequately acidify the sample to drive off the IC to avoid IC interference in your TOC reading.

Citrajet contains 14% (w/w) Total Organic Carbon (and no inorganic carbon). This means that 100 g of Citrajet contains 14 g of TOC. In terms of concentration this means that a 1% solution of Citrajet (10 g Citrajet/L) contains 1.4 g TOC/L (10 g Citrajet * 0.14 g TOC/g Citrajet).

You can derive any concentration information regarding TOC in Alcojet and Citrajet from the relationships given in these examples of how to do the calculation.

In the Alconox, Inc Cleaning Validation References it states:
Total Organic Carbon (TOC) analysis has been reported to detect the organic surfactants present in ALCONOX®(11% w/w), LIQUI-NOX®(21% w/w), (TERG-A-ZYME® 11% w/w), ALCOJET®(1.5% w/w), ALCOTABS®(20% w/w), DETERGENT 8®(38% w/w), LUMINOXtm(26% w/w) CITRANOX®(17% w/w) and CITRAJET® (14% w/w). You must go through the acid neutralization step or use the inorganic carbon channel on the TOC analyzer to account for inorganic carbon.

Need cleaning validation assistance? Ask the Critical Cleaning Experts at Alconox.

Detergent Last to Rinse

Question:
What does "detergent is the last to leave the equipment surface" after rinsing mean? This seems like a broad statement, can it be supported by literature/documentation?

Answer:
The only source of "detergent last to rinse" that I am aware of is based on the physical behavior of surface active agents and the interchangeable use of the word detergent and surfactant in common usage. More properly you should say the surfactant is the last to rinse. Surfactants or surface active agents are made of molecules that have one end that is hydrophilic (water loving) and the other end is hydrophobic (water hating). Surface active agents in aqueous solutions are attracted to solution surface interfaces because the hydrophobic end of the surfactant molecule is repelled from the bulk water solution while the hydrophilic end of the molecule is attracted to the water solution.

In theory the surfactant is most stable when arranged in a film. The film's structure is made up of one side where the hydrophobic tails are facing outwards towards the solution/surface interface and the hydrophilic ends of the molecules are facing inward towards the water solution. By increasing the concentration of surfactants by adding detergent to a water, a monolayer surfactant film will form in the solution until a critical micelle concentration is achieved (micelles are balls of surfactants arranged with their hydrophobic ends facing inwards and their hydrophilic ends facing outwards - micelles are responsible for emulsifying because the inner regions of micelle can hold hydrophobic oily molecules emulsified in the water solution). Cleaning is typically done with surfactant concentrations above the critical micelle concentration. As the cleaning solution is rinsed away, you drop below the critical micelle concentration of surfactant, promoting mass displacement of the micelles as well as the remaining surfactant molecules (either individual or monolayer) by rinsing. Continued rinsing further dilutes the monolayer and removal of the surfactants, thereby essentially being the last molecules from the cleaning system to rinse away.

As a practical matter with the limits of quantitation in the analytical methods used for cleaning validation studies and crude successive rinse studies, Alconox, Inc technical support has never heard of detecting different rates of rinsing among highly water soluble detergent ingredients. As a practical matter with highly water soluble detergent ingredients, all ingredients seem to rinse at the same rate in dip rinsing studies. Over 4 rinses, in the 3rd rinse all ingredients were detected, and by the 4th rinse they were all gone. Successive rinse methods were not fine enough to detect the subtle effect of the last to rinse away surfactant.

Need help selecting a cleaner for you manufacturing equipments? Ask the Critical Cleaning Experts at Alconox, Inc.

Ingredients in Alconox Brand Cleaners

Question:
In addition to surfactants, what other types of ingredients can be found in Alconox brand cleaners?

Answer:
Dispersant-This is a cleaner ingredient that helps disperse or suspend solid particles in solution. Dispersants include water-soluble surfactants or water-soluble polymers (long-chain organic molecules) that are electrostatically attracted to particulates, creating a bridge between the water and the water insoluble solid particulate (in some cases even repelling the solid surface to help lift the particles into suspension).

Emulsifiers-These cleaner ingredients help emulsify water insoluble oils into solution by helping to create a liquid-liquid mixture. Surfactants that use their hydrophobic (water-hating or repelling) or oleophilic (oil-loving) end of their molecule to mix with water-insoluble oils and their hydrophilic (water-loving) end to mix with water create a bridge to emulsify water insoluble oils into solution. The specific structure of the bridge is called a micelle that can be thought of as a hollow, oil-filled round ball with a skin made of surfactants with their hydrophilic ends facing out in contact with the water solution and the hydrophobic ends facing in to the oil-filled ball.

Wetting agents-These are surfactants that lower the surface tension of water and allow the cleaning solution to wet surfaces and penetrate into, under and around soils and surface crevices. They create a bridge between the water and any hydrophobic (water-hating or repelling) surface. You can think of a wetting agent as having one end of the molecule attracted to the surface while pulling the water solution towards the otherwise water-repelling surface, allowing the water solution to be in contact with more of the surface that needs to be cleaned. You might say that wetting agents make water wetter.

Builders-These cleaner ingredients react with interfering calcium, magnesium, or iron ions that may be present in the water solution. They stop them from reacting with soils and other detergent ingredients to form water insoluble and difficult-to-clean calcium, magnesium, or iron salts. These metals are present to varying degrees in all water, particularly tap water. Builders are usually alkaline salts, chelating agents, and/or sequestering agents.

Alkaline salt builders-These are inorganic salts such as sodium carbonate or sodium phosphates. They react with calcium, magnesium, or iron to form water soluble or water dispersible compounds that tie up the calcium, magnesium, and iron.

Chelating agents-These are negatively charged or oxygen containing molecules that react with positively charged metal ions to form a stable complex. They have multiple locations in the molecule to react with multiple positive charges that may be present on multivalent metal ions that have more than one positive charge on them. An example of a chelating agent is EDTA, ethylene diamine tetraacetic acid. EDTA has four acetic acid groups giving it a potential for four negatively charged acetates to bond with up to four positively charged sites on metal ions with multiple positive charges, such as calcium which has two (2) positive charges associated with it.

Trying to validate a pharmaceutical cleaning process, ask the Critical Cleaning Experts at Alconox.

Types of Surfactants

Question:
What are the different types of surfactants?

Answer:
Anionic surfactants - These have a negatively charged end of the molecule that gives it the hydrophilic part of the molecule. These negatively charged parts of the molecules are usually sulfonates, sulfates, or carboxylates that are usually neutralized by positively charged metal cations such as sodium or potassium. Examples include sodium alkylbenzene sulfonates, sodium stearate (a soap), and potassium alcohol sulfates. Anionic surfactants are ionic and are made up of two ions—a positively charged, usually metal, ion and a negatively charged organic ion.


Nonionic surfactants - These are surfactants that have no ions. They derive their polarity from having an oxygen--rich portion of the molecule at one end and a large organic molecule at the other end. The oxygen component is usually derived from short polymers of ethylene oxide or propylene oxide. Just as in water chemistry, the oxygen is a dense electron-rich atom that gives the entire molecule a partial net-negative charge which makes the whole molecule polar and able to participate in hydrogen bonding with water (as discussed in the first chapter). Examples of nonionic surfactants are alcohol ethoxylates, nonylphenoxy polyethylenoxy alcohols, and ethylene oxide/propylene oxide block copolymers.

Cationic surfactants - These are positively charged molecules usually derived from nitrogen compounds. They are not commonly used as cleaning agents in hard-surface cleaners because of the tendency of the cationic positively charged molecule to be attracted to hard surfaces (that usually have a netnegative charge). Many cationic surfactants have bacteriacidal or other sanitizing properties that are useful in creating disinfectants that leave a cationic disinfectant film on the surface.

Cationic surfactants are usually incompatible with anionic surfactants, because they will react with the negatively charged anionic surfactant to form an insoluble or ineffective compound.

Amphoteric surfactants - Those surfactants that change their charge with pH. They can be anionic, nonionic, or cationic depending on pH. Usually, any one amphoteric can be any two of the three charge states.

Need help with Cleaning Validation? Ask the Critical Cleaning Experts at Alconox.

Surfactants

Question:
What is a surfactant?

Answer:
Surfactant is short for “surface active agent,” it is an organic molecule with a hydrophobic (water-hating/oil-loving) end and a hydrophilic (water-loving) end. Surfactants are often emulsifiers, wetting agents, and dispersants (see other definitions).

The most common surfactant is sodium Linear Alkylbenzene Sulfonate (called LAS for short). The alkylbenzene portion of the molecule is the hydrophobic/oleophilic end of this surfactant and the negatively charged sulfonate molecule is the hydrophilic end of the molecule. Surfactants are typically classified as anionic, nonionic, and cationic. The class of surfactant determines the class of the cleaner.

Water-based Cleaner

Question:
Is a water-based cleaner the same as an aqueous cleaner?

Answer:
Yes! Aqueous means water. A water-based or aqueous cleaner is a cleaner that increases the ability of water to clean. An aqueous cleaner uses blends of detergent compounds with surface active agents together with other cleaning chemicals that use detergency to lift soil from a surface by displacing it with surface active materials that have a greater affinity for the surface than for the soil.

Water, considered by many to be the "universal solvent," is an important component of aqueous cleaners because it dissolves many types of soils. Water-municipal tap water, deionized or distilled water depending upon the cleaning application-also functions as a carrying medium for detergent compounds. But, while water is capable of dissolving many inorganic and some organic contaminants, not all residues dissolve readily in water. For this reason, aqueous detergent cleaners are complex mixtures specifically formulated to create greater chemical and mechanical cleaning action.
Water is a polar solvent. Being polar is the characteristic that makes it good at dissolving a wide range of polar residues, contaminants and/or soils. Water has a unique V shaped structure with two hydrogen atoms at the top of the V and an oxygen at the bottom. One can think of the oxygen as being a large, dense electron rich atom.

This gives the entire water molecule an overall net negative, electron-rich end at the base of the V (d-) and an electron poor positive end (d+) of the molecule towards the hydrogen top of the V. This directional net-negative charge towards the base of the V is called a dipole moment. Polar molecules such as water have a dipole moment.
Alconox, Inc manufacturers a full line of aqueous cleaners widely used in a range of industries, including pharmaceutical and medical device.

Aqueous Cleaners

Question:
What is an Aqueous Cleaner?

Answer:
Alconox, Inc manufacturers a full line of aqueous cleaners widely used in a range of industries, including pharmaceutical and medical device. An aqueous cleaner is a blend of ingredients designed to enhance the cleaning ability of water. Typically an aqueous cleaner contains a surface active agent (surfactant) and builders to help the surfactant. The surfactant acts as a wetting agent to allow the cleaning solutions to penetrate into crevices and around and under soils. The surfactant will usually also act as an emulsifier to help form emulsions with water in soluble oils. The builders usually react with dissolved metal ions in the water to help stop them from interfering with cleaning.

Inhibited Cleaner for Aluminum

Question:
Specifications for indicate that "Solujet is inhibited for Aluminum. Corrosion testing is advisable." What does this mean?

Answer:
Solujet contains sodium metasilicate which acts as a corrosion inhibitor to stop alkaline attack on aluminum. Solujet would not cause alkaline attack on aluminum as long as the bath is not overused and the metasilicate depleted.

There are galvanic (forming a battery) attacks on aluminum that involve interactions with other metals that may be dissolved in the cleaning solution from prior use, or that may be present as metal in the tank or part being cleaned, and this form of attack will happen with just about any detergent solution including Solujet. Ideally you should not clean other metals in baths used to clean aluminum and should not have other metals that have significantly different galvanic potential than aluminum present in the cleaning solution. If there is any concern that there may be other metals involved, then some testing may be advisable. If the aluminum parts being cleaned are very high value parts, then some testing would be advisable.

Certainly Solujet is designed to clean aluminum safely. Aluminum is a reactive metal, especially if it has been recently machined, cut or tooled so that there is exposed, freshly cut aluminum that has not had a chance to form a protective passive layer of alumninum oxide, which happens naturally with exposure to air. If the protective passive layer is not formed then you can get all sorts of strange galvanic reactions that are not technically corrosion, but which will result in discoloration due to deposits of whatever the other metal or metal oxide on the surface of the aluminum.

Alkylphenol Ethoxylates and Phosphates

Question:
Which Alconox detergents contain alkylphenol ethoxylates and which ones contain phosphates?

Answer:
Liquinox and Citranox contain alkylphenol ethoxylates. Alconox, Tergazyme, Alcojet, Alcotabs, and Detojet contain phosphate. Detergent 8, Luminox, Citrajet, Solujet and Tergajet contain no alkylphenol ethoxylates and no phosphates.

Plastic Container for Soak Solutions

Question:
What kind of plastic container can I use to hold a detergent soak solution?

Answer:
You can use any container that is robust enough to hold typical aqueous solutions of chemicals. A polypropylene or other chemical resistant plastic container such as HDPE (just about anything but polycarbonate or polyurethane) will work just fine for cleaning. If you have specific residue concerns, you should consider the possibility of certain metals or monomers leaching out of the plastic. For general purpose laboratory and medical cleaning this is typically not a concern because the anti-redeposition properties of the detergent are sufficient to stop anything that leaches out of the container from depositing on the substrate being cleaned.

Cleaning Filters with Tergazyme

Question:
What kind of cleaning can I expect from Tergazyme when cleaning filters with wine residues?

Answer:
We would expect Tergazyme to work very well on biofilms or microbial contamination from filters that had been repeatedly used to filter wine. It will do quite well on assorted organic residues from various components of wine. The one cleaning mechanism that Tergazyme does not have is oxidation or bleaching. This means it would not be unusual if some trace color was left of some difficult to hyrdrolyze condensed tannins or other coloring agents from the wine. Certainly Tergazyme would do something on these residues, but it would not be as dramatic as using bleach or peroxide to oxidize or even possibly metabisulfite to reduce these residues. Of course if there is a biofilm , neither bleach, peroxide, or metabisulfite will be as effective as Tergazyme.

Detergent Testing

Question:
What kinds of test soils are used in detergent testing?

Answer:
Synthetic soils are often applied to coupons to use in testing detergents. Typically a soil will be made from some kind of binding natural oil such as vegetable oil or vegetable shortening combined with a protein such as whey powder or egg powder. Additionally there may be motor oil or used motor oil; vacuum cleaner bag dust; carbon black; and clay soils. Sometimes these mixtures would have synthetic hard water such as 150 ppm hardness (2/1:Ca+2/Mg+2) mixed in. In general you want your synthetic soil to mimic the type of residue that you are trying to develop a detergent or cleaning process to clean.

Posted Inhibitory Residue Tests

Question:
How many years are the IRTs posted?

Answer:
Three years, so currently 2007, 2006 and 2005 Inhibitory Residue Tests are posted. If IRTs from years earlier than that are needed, please contact Alconox directly.

Inhibitory Residue Test

Question:
How do I get an IRT?

Answer:
To get a lot number specific inhibitory residue test to comply with accreditation guidelines requiring lot specific or annual testing, get a certificate of analysis (COA) for the detergent you have. These COA’s can be found at http://www.alconox.com/section_dealers/certif_coa.asp

Lot numbers that you will need to get your COA are found at the top of 4 lb boxes (milk cartons), above the label on bottle, and on the side of the corrugated box for larger sizes and cases. These lot numbers are a "sub lot" of a specific master lot. Once the master lot number is identified on the COA, the inhibitory residue test data can be downloaded at www.alconox.com.

Master lot numbers change in the unusual event of a significant change in raw materials or manufacturing. Master lot numbers change such that each lot can be traced to a Master lot that was tested within one year.

Inhibitory residue tests are performed for each year's worth of sub lot numbers.

IRTs for Alconox Brands

Question:
Does Alconox, Inc have IRTs for each brand?

Answer:
Yes, annually Alconox, Inc has each brand tested through an independent laboratory. Brands include Alconox, Alcotabs, Alcojet, Citranox, Citrajet, Detojet, Detergent 8, Liquinox, Luminox, Solujet, Tergajet, Tergazyme.

Inhibitory Residue Test

Question:
What is an Inhibitory Residue Test?

Answer:
The inhibitory residue test is a test of suitability of glassware for microbiology testing. It was important when labs were using phosphate detergents, but is less so now that use of phosphate is being phased out. The test is described in SM 9020B3a (Editions 18, 19) or SM 9020B4a (Editions 20, 21).

Standard Methods says to do the test "as necessary." You might ask your regulator how they interpret that.

First and foremost, it tests the detergents/soaps used for washing glassware in the microbiology section of a lab to make sure that they do not have bacteriostatic or inhibitory qualities that may affect the microbiological test that you perform (such as multiple tube fermentation technique...). Secondly, it also "checks" your washing procedure to make sure that if there are any inhibitory/bacteriostatic substances present in your soap, the cleaning process that you employ washes out any of these inhibitory substances.

Labs that are certified for drinking water microbiology have to perform the inhibitory residue test as well as the distilled water suitability test ANNUALLY. Another source of information about these tests is in EPA's "Manual for the Certification of Laboratories Analyzing Drinking Water". The most current is the 5th Edition published in 2005.

Bath Life Extension

Question:
What is the best way to monitor for bath life extension?

Answer:
To avoid potential for cross contamination, only freshly made up cleaning solutions should be used for the highest levels of critical cleaning. For industrial critical cleaning applications, high levels of cleaning can also be achieved with extended bath life. In general, a pH change of 1 unit towards neutral indicates an exhausted cleaning solution. Bath life can be extended by physical filtration of particulates, cooling and settling of sludge and skimming of oils. Bath life can also be extended by adding one half as much detergent, of the initial load, after partially depleting the cleaning life of the bath. With frequent daily use, detergent solutions can rarely be used longer than a week even with these bath life extension techniques. Conductivity, pH and % solids, by refractometer, can be used to control bath detergent concentration.

Free alkalinity titration can be used to control bath life of alkaline cleaners where the soil being cleaned depletes free alkalinity-as is often the case with oily soils. The process:

1. Titrate a new solution to determine free alkalinity.
2. Titrate the used solution to determine the percent drop in free alkalinity.
3. Add more detergent to the bath to bring the free alkalinity back to the level of the new solution. (For example if the initial solution is made up with 100 ml of cleaner concentrate and a 25% drop in free alkalinity is observed, try adding 25 ml of cleaner concentrate to recharge your solution.)

Perform a new free-alkalinity titration to confirm the recharge the first few times this recharging method is used. This is to ensure that the detergent being used is linear with respect to free alkalinity depletion. This form of bath life extension cannot run indefinitely, sludge will eventually form. Fresh solutions must be made up periodically. Bath lives can also be extended using conductivity.

Most cleaners contain conductive salts which can be detected using conductivity. Once the conductivity response of the detergent is determined, the depletion of those conductive salts can be measured. Typically, this kind of measure the bath and recharge with detergent process can be done 2-3 times before a new bath is needed.