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.