Alkaline and Degreaser Cleaning of Aluminum

Question:
Can aluminum be safely cleaned with alkaline cleaners and degreasers?

Answer:
Typical alkaline cleaners and degreasers attack aluminum. Use of corrosion inhibited alkaline cleaners such as Alcojet or Detojet that contain proper ratios of silicates to form aluminosilicate at activated sites on the aluminum surface prevent aluminum oxide formation or corrosion during alkaline cleaning. It is always safer use lower temperatures to retard corrosion. Alternatively, cleaners that are below pH 9.5 such as Alconox or Liquinox can be used at temperatures (below 140 deg F) with limited contact time (under an hour) to reduce corrosion.

To learn more about Alconox brands, visit our homepage.

Alconox Booth #1428 at INTERPHEX Puerto Rico 2009

Question:
Will Alconox, Inc attend the INTERPHEX Puerto Rico 2009 Pharmaceutical Manufacturing Conference and Exhibition?

Answer:
YES! Alconox, Inc booth #1428 at INTERPHEX Puerto Rico 2009 Pharmaceutical Manufacturing Conference and Exhibition at the Puerto Rico Convention Center, San Juan on January 29-30.

Visit the Critical Cleaning Experts at Alconox, Inc at booth #1428 for safe, effective, easy to-validate aqueous cleaners for manual, machine wash and clean-in-place applications - even for removing titanium dioxide, petrolatum, and tablet coating residues! All brands are free rinsing, biodegradable and readily disposable.

Get your FREE Hardcover Handbook - 187 pages!
&
DEMO new Calculator for Residue Limits!

Great opportunity to "Ask Alconox" and get expert advice about your industrial cleaning needs!

Mark your calendars for INTERPHEX Puerto Rico 2009 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.

Questions about Medical Device Cleaning Validation

Question:
Does Alconox, Inc. answer questions about med dev cleaning validation?

Answer:
Yes, the Alconox, Inc. Critical Cleaning Experts are available to assist in medical device cleaning validations. We provide a comprehensive directory of residue detection methods for all Alconox brands, residue sampling methods, and assistance in calculating acceptance criteria.

If you require assistance with a med dev cleaning validation, contact us! We can be reached by email at cleaning@alconox.com or by phone at 914-948-4040!

Static and Dynamic Spray Balls in CIP

Question:
What are the differences between Static and Dynamic spray balls in CIP machines?

Answer:
The typical considerations in using either static or dynamic spray balls are that static spray balls can be placed strategically within a mixer to try to assure spray contact with all sides of various mixing apparatus inside the tank. Static spray balls typically rely on a high-volume, low-flow cascading cleaning action wherein much of the mechanical energy comes from the sprayed on solution running down the sides and surfaces of the tank being cleaned. Dynamic spray balls have low-volume, high-pressure spray with the spray nozzle spinning around while simultaneously rotating to direct a jet of spray to all interior surfaces of the tank. Dynamic spray balls have more mechanical energy applied during cleaning. There are concerns with the possibility that dynamic spray balls can jam up and stop rotating or stop spinning during a cleaning cycle. Dynamic spray ball manufacturers are developing sensors that monitor the performance of the spinning and rotating to be able to document and verify correct performance. When designed and installed properly, both kinds of spray balls can provide reliable cleaning. When using CIP systems with either static or dynamic spray balls in large tanks and mixers, Alconox, Inc recommends using low foaming detergents such as alkaline Solujet or acidic Citrajet.

For more information about the use, validation and selection of detergents for pharmaceutical, biotechnology and cosmeticeutical cleaning, please click here.

pH and dissolved oxygen probe cleaning

Question:
Which Alconox brand cleaner is well suited for cleaning pH and dissolved oxygen probes?

Answer:
Dissolved oxygen and pH probes used in fermentation vessels can get buildup from the fermentation media that degrades the probe performance and increases the likelihood of batch to batch contamination. Even CIP systems cannot always reliably clean the port crevices and o-rings. This is a particular problem with proteins found in pharmaceutical, biotech, cheese and brewery manufacturing. Use a 1% Tergazyme solution that does not exceed 130 deg F (55 deg C), preferably around 120 deg F (50 deg C). Clean manually with a small brush. Rinse thoroughly with water of suitable purity for your industry. O-Rings and other removable parts can be soaked in a warm (120 deg F, 50 deg C) solution for 20 minutes prior to final brushing and rinsing.

To view the technical bulletin for Tergazyme, Enzyme Active Cleaner, please click here.

Mold Release and Silicon or Polysilane Oil Removal

Question:
How do you remove silicon mold releases and polysilane oils from stainless steel, plastic and glass?

Answer:
Silicon mold releases and polysilane oils are very difficult to remove filmy residues. Mold release agents on glass act as a protective film on the glass attempting to clean them off with very aggressive acid or alkaline cleaners, the cleaning agent etches around the edges of the mold release agent and the un-coated sections of the glass, leaving behind a shadow of where the mold release was or had been. Even if the cleaner does eventually remove the mold release, there is a permanent shadow of where it had been due to the etching that occurred where the mold release had been. This same effect has also been with fingerprints on glass. If there is a silicon mold release agent on the glass, remove it with ultrasonic cleaning with extremely hot (over 170 deg F or over 77 deg C) 2% Alconox followed by a thorough rinse. Ideally, make sure the first rinse is with extremely hot water. Typically 10-20 minutes in ultrasonics is adequate to remove the residue. Alconox is a mild cleaner and will not etch the glass under normal cleaning conditions. On plastic first make sure your plastic is compatible with exposure to these temperatures. As we best understand it, many polysilanes have a softening point at somewhere in the 160-170 deg F (72-77 deg C) range. Above that softening point, the polysilanes can be more readily emulsified by a strong emulsifier. A 2% Alconox solution is a strong emulsifier and has been successfully used to remove difficult silicon oil residues. Once the polysilane is emulsified, you want to rinse it with hot water so that cold rinse water does not break the emulsion and redeposit the silicon oil before it has a chance to be rinsed away. The cleaning temperature is critical here. If this is a smooth, cleanable and easily rinsed surface, you can often get away without having to use a very hot water rinse. If there are crevices, blind holes or other features to the glass that would slow down the rinsing, then the very hot first rinse is critical tool Once you have done an initial static or running water initial very hot rinse, then subsequent rinses can be usually be done with ambient temperature water. Note that if extremely high purity deionized or reverse-osmosis water is used for the first very hot rinse, this water can etch glass; although at least it should be a uniform etch because there should no longer be a mold release mask on the glass. To avoid this, use tap water for the first very hot rinse, followed by cooler or ambient temperature higher purity water if a high purity water rinse is required to avoid water spots or other tap water residues. Note that as far as removing the mold release is concerned, tap water rinses will work just fine. The reason to use any higher purity water rinse is to avoid water spots or other tap water residues. These tap water residues can also be minimized by physically removing the tap water and not allowing it to evaporate and deposit - this can be done by blowing off the rinse water, wiping it off, or removing it using a drying solvent like isopropyl alcohol.

To view the technical bulletin for Alconox, Powdered Precision Cleaner, please download this PDF.

Cleaning Lab Glassware Exposed to Sea Water

Question:
What is the proper way to clean lab glassware that has been exposed to sea water?

Answer:
Sea water contains a large and variable quantity of salts, biological and organic residues. Lab glassware needs to be free of any of these residues to avoid interference in research involving sea water. Sea water would not particularly present challenges beyond the normal array of residues that lab glassware sees in the wide variety of types of lab glassware that Alconox, Inc. laboratory detergents are used to clean. A standard cleaning protocol, see the users manual at the top right hand corner of this web page, will work fine. For typical manual cleaning wash with 1% Alconox or Liquinox in warm water followed by a thorough rinse in water of suitable purity) for standard laboratory cleaning requirements. If you are doing some extremely sensitive analytical procedure with the glassware (beyond ppm analytical detections), then you will want to pay particular attention to your rinsing technique and the quality of your rinse water. In general use deionized water for inorganic analysis rinsing and distilled water for organic analysis rinsing. Carbon filtered or reverse osmosis water can be used in place of distilled water typically. Rinse more than the standard three time rinse for more critical analytical glassware. In the event of glassware used for extreme low level inorganic analysis, an intermediate acid wash step after cleaning with the Alconox or Liquinox will improve cleaning. For manual cleaning use a warm 2% Citranox for the acid cleaning step prior to the final thorough rinse.

To learn more about Alconox brand detergents, ask the experts at cleaning@alconox.com.

Optic Cable Cleaning

Question:
Which Alconox brand cleaner would be best suited to clean fiber optic surfaces at the glass joint to assure efficient light transmission?

Answer:
The use of a 1% Alconox heated 130 deg F ultrasonic bath followed by a deionized water rinse gives a suitable surface for bonding optical fibers.

More information about Alconox, Powdered Precision Cleaner, can be downloaded by clicking here.

Lens Cleaning

Question:
How do you clean wax marks on optical lenses which are difficult to remove?

Answer:
Use either 1% Alconox or Liquinox in a heated 160 deg F ultrasonic bath followed by a deionized water rinse to clean optical lenses during manufacturing.

To learn more about Alconox, Powdered Precision Cleaner and Liquinox, Critical Cleaning Liquid Detergent, please visit Alconox.com.

Cleaning Nylon 6

Question:
Can Nylon 6 be successfully cleaned with high alkaline cleaners?

Answer:
Nylon 6 is generally labile to acids and oxidizing agents. Nylon 6 would be fine with an alkaline cleaner like Solujet. Nylon 6 is labile to strong oxidizing agents. Alcojet and Detojet contain small amounts of active chlorine oxidizing agents. At the high pH of these cleaners, the oxidizing agent is pretty stable and is not that strong an oxidizer, so do not expect rapid attack on Nylon 6, but given sufficient time and temperature, expect to eventually see some effect from Alcojet and Detojet.

To learn more about alkaline cleaners, visit Alconox.com.

PMMA alkaline cleaning

Question:
Is PMMA (Poly methylmethacrylate acrylate) compatible with Alconox brand high pH alkaline detergents?

Answer:
Poly methylmethacrylate acrylate (PMMA) is compatible with alkaline detergents like Solujet. PMMA is labile to strong oxidizing agents. Alcojet and Detojet contain small amounts of active chlorine oxidizing agents. At the high pH of these cleaners, the oxidizing agent is pretty stable and is not that strong an oxidizer, so a rapid attack is not expected on PMMA, but given sufficient time and temperature, expect to eventually see some effect from Alcojet and Detojet on PMMA.

To learn more about alkaline detergents, visit Alconox.com.

Neutralizing Solujet using Citric Acid

Question:
How much Citric Acid is needed to neutralize 100 gallons of Solujet below pH 7?

Answer:
100 gallons of 1% Solujet solution is 833.3 pounds. 833.3 pounds of 1% Solujet solution
contains 8.3 pounds of Solujet. The amount of citric acid needed to neutralize the solution below pH 7 is 1.67 pounds of citric acid.

For more information on Solujet, please download our PDF.

Citric Acid vs. Citranox

Question:
Is Citranox comparable to citric acid?

Answer:
Yes, 1% Citranox can be used to replace the kind of cleaning achievable from 1% citric acid. Citranox formulation is approximately 1/3 citric and other organic acids by weight, but there are also wetting and penetrating agents that enhance the performance of the acids, so that although to really get a roughly equivalent amount of acid you would need to use a 3% Citranox solution. Silica and other residues that the 1% Citric acid is designed to remove could also be removed by a 1% Citranox solution. Extremely heavy scale buildup can be removed by a 1% solution of Citranox. The solution will eventually become exhausted - an exhausted solution will typically be very heavily discolored and the pH will have risen to higher than a pH of 5.5. Instead, a 1.5% or 2% solution of Citranox can be used.

For more information on Citranox, download our PDF.

Detojet, Low-Foaming Liquid Detergent

Question:
What industries commonly use Detojet and what residues does Detojet remove?

Answer:
Detojet, Low-Foaming Liquid Detergent is used in a variety of industries such as Healthcare, Laboratory, Precision Manufacturing and Metalworking and Food & Dairy. Detojet is an alkaline non-ionic cleaner that would remove soil, tares, resins, grease, blood, tissue, oils, particulates, chemicals, and solvents.

For more information on Detojet, please see the technical bulletin.

General and Current Good Manufacturing Practice for Finished Pharmaceuticals

Question:
What part of the FDA Code of Federal Regulations applies to cleaning equipment?

Answer:
The FDA Code of Federal Regulations 21 CFR 211.67 applies to equipment cleaning and maintenance. If you are cleaning pharmaceutical equipment with Alconox brand cleaners, our team of experts can assist you in your cleaning validation. For more information on how the Alconox team of validation consultants can assist in your pharma cleaning validation, e-mail us at cleaning@alconox.com or call us at 914.948.4040. If you need pharmaceutical cleaning validation information, visit our website to view the Alconox Pharmaceutical Cleaning Validation References.

Chemistry Bath-life extension and control

Question:
How can bath-life be monitored?

Answer:
Some very simple, yet effective, techniques can be used to monitor bath life, including:

• Conductivity—When you are using detergents with high ionic content, measurement of the ionic content of the cleaning solution, using electrodes connected to a conductivity meter, helps determine when to add more detergent to the cleaning solution. Detergents high in salt content, for example, potassium hydroxide or sodium metasilicate, generally, have high ionic content. Conductivity will drop as soils react with the salts. This is not a useful technique for monitoring high emulsifying cleaners that rely heavily on surfactants.
• Refractometry—This is the indirect measure of the concentration of dissolved components which influence the refractive index of a sample of solution. The measurement may be taken using a simple handheld refractometer. Refractometry can also be used to monitor the build up of soils and concentration of a solution as a result of water evaporation. Empirical observations of cleaning solutions may be compared with recorded measurements to determine appropriate times to recharge or discard solutions.
• Foam Height—The foam height and foam stability, in a sample of cleaning solution in a vigorously-agitated, stoppered test tube will decrease as oils accumulate. When foam height decreases, recharge or discard cleaning solutions. Observations must be made at consistent temperatures.
• pH—This is the measurement of the acidity or alkalinity of a solution on a scale of 0–14. It is expressed as the negative log of the hydrogen ion concentration, which is measured using electrodes dipped in the solution connected to a pH meter. Note that pH paper should not be used with surfactant-containing cleaners, because they commonly hamper accurate reading. A given brand of detergent will have a typical pH. If the soils are acidic, inorganic, or saponifiable natural oils, the pH will drop as the cleaning solution is used up. Typically, when pH drops 0.5 pH units, the detergent should be recharged. Then the solution can be used to exhaustion as it drops one full pH unit. The technique chosen to monitor bath life will depend on the both the type of detergent you are using and the soil or residue you are removing. For example, when cleaning with an ionic detergent, use conductivity to monitor dilution, dragout, and loss of detergent. Whereas, when using a highemulsifying or dispersing detergent to remove oils or particulate soils, refractometry is an effective means of measurement and control. Foam height observation is most effective when cleaners contain foaming surfactants that rely on emulsification to remove oily soils. When using an alkaline cleaner to remove a soil that is either acidic or neutralizing in character (as most soils are), pH can be used as a control measure.

- The Aqueous Cleaning Handbook, 4th Ed. p 127-128

To request a FREE copy of The Aqueous Cleaning Handbook, 4th Ed., please click here.

Cleaning Ceramic Aluminum Oxide and Polysulfone

Question:
Is Detojet, Low-Foaming Liquid Detergent, compatible with ceramic aluminum oxide and polysulfone?

Answer:
Detojet solutions are compatible with aluminum oxide ceramics. There is need to be concerned about polysulfone. Alconox, Inc. has some data that indicates that polysulfone reverse osmosis membranes will have the permeability of the membrane reduced by exposure to oxidizing agents such as sodium hypochlorite. Detojet contains sodium hypochlorite. Detojet also has a very high pH and contains potassium hydroxide. A high pH from the potassium hydroxide reduces the oxidizing activity of sodium hyprochlorite, so there is some compatibility between polysulfone reverse osmosis membranes and Detojet, but probably not continuous long term exposure compatibility.

Alconox, Inc. recommends stability testing for a polysulfone cleaning application and intended type of contact to determine if the Detojet is compatible. For single pass initial cleaning, the polysulfone would be fine. For repeated or extended Detojet contact, depending on the intended purpose of the polysulfone, there might be problems.

For more information on Detojet, please download this PDF.

Ultrasonic Cleaning with Alconox brand cleaners

Question:
Which Alconox brand cleaners can be used in an ultrasonic machine?

Answer:
All Alconox brands can be used in ultrasonic machines. Alconox powder brands or liquid brands can be used in ultrasonic machines and the choice can be based on convenience. Alconox, Inc. generally recommends using high emulsifying detergents. For example, Tattoo companies use Alconox, Powdered Precision Cleaner or Tergazyme, Enzyme-Active Powdered Detergent in ultrasonic machines for cleaning equipment with blood residues. Medical Device Manufacturing companies use Liquinox, Critical Cleaning Liquid Detergent to clean small stainless steel parts in ultrasonic machines. Alconox low-foam cleaners, such as Solujet and Alcojet can be used in ultrasonic machines as they are formulated to have superior detergency. It is important to remember to follow safety precautions when cleaning ultrasonically. Wear proper eye, hand, and body protection.

To learn more about ultrasonic cleaning with Alconox brand detergents, please visit Alconox.com.

Pharma Cleaning Validation – Swab Limit Calculations

Question:
How do you calculate the swab limit, once it has been extracted in solution?

Answer:
In general the calculations go as follows:

swab limit (ug residue/swab) = acceptance criteria (ug residue/cm2) X swab area (cm2) X swab recovery (%)

acceptance criteria = ug residue/cm2 of a given residue
swab area = cm2 of area swabbed
swab recovery = the percent actually detected compared to a spiked surface area of known amount of residue (amount detected/amount swabbed X 100)

To convert swab limits to test result limits by converting ug residue/swab to ug residue/mL based on the extraction volume that is used to extract the swab for analysis.

The general equation is:

test result limit (ug residue/mL) = swab limit (ug residue/swab) / mL of extraction solution.

If you need help calculating swab limits for pharmaceutical cleaning validation, contact the experts at cleaning@alconox.com.

Disposal of Citranox

Question:
What is the proper way to dispose of Citranox?

Answer:
By US federal standards, Citranox can be disposed of to drain as is. It is non-hazardous waste by federal RCRA standards. Local waste treatment standards could be more stringent and might require neutralization prior to discharge. The Citranox will have a pH of between 2.1 and 2.5 as is and it is possible this would be too acidic to discharge without neutralization according to local standards. A single gallon is unlikely to be that much of a concern, but if local standards are not known be extra cautious and neutralize the Citranox using any weak base such as baking soda (sodium bicarbonate) or washing soda (sodium carbonate). It takes 14 lbs. of baking soda or 2.3 lbs of washing soda to neutralize 1 gallon of Citranox to near pH 7.

To view a technical bulletin for Citranox, please read this PDF.

Detergent Residue Testing - Conductivity for Alcotabs

Question:
Does Alconox have any information on using conductivity to test for residue of Alcotabs detergent?

Answer:
Yes, if you are testing for ALCOTABS detergent, please adapt the procedure to use a conductivity meter and deionized water that is sensitive to ionic detergent residue.

To read more about the procedure, please download this pdf.

Copper Cleaning

Question:
Which Alconox brand cleaner can be used to remove metal oxides from small Copper parts with attached plastic components?

Answer:
The emulsifiers and surfactants in Citranox, Acid Cleaner and Rinse, are ideal for the removal of metal oxides. Citranox is also ideal for soak and manual cleaning and can be used on soft metals such as copper. Start with a 2% solution of Citranox for the soak in warm water. Make sure to rinse thoroughly.

To read more about Citranox please download this pdf.

Med Dev Validation Info

Question:
What med dev information is in the Medical Device Cleaning Validation References?

Answer:
The Medical Device Cleaning Validation References for Alconox Detergents contains information about identifying residues, selecting a residue detection method, selecting a sampling method, setting residue acceptance criteria, and more. Also included is a directory of cleaner residue detection methods for each Alconox detergent. Also available is the Alconox team of experts who provide validation support. To get a copy of the Alconox Medical Device Cleaning Validation References or to speak with a cleaning validation expert email cleaning@alconox.com or call 914-948-4040.

MedDev Cleaning Validation Consultant

Question:
Does Alconox, Inc. offer validation consultants to provide validation tech support?

Answer:
Yes, Alconox can provide valuable consulting and information to medical device manufacturers. Our critical cleaning experts can discuss validation concerns such as techniques for determining acceptable residual levels and analytical methods for residue quantitation.

Alconox, Inc. supplies detergents to medical device manufacturing companies that require exacting levels of quality control and technical service. Alconox, Inc. provides support for regulatory-compliant cleaning validations which includes lot number traceability of all cleaners and ingredients, cleaner toxicity and reactivity/degradation information, shelf-life testing, residue sampling, detection methods and written cleaning procedures.

Discuss worst case critical cleaning issues with the experts. 'Ask Alconox' at cleaning@alconox.com.

Pharma Cleaning Validation - Residue Detection Method Selection

Question:
What are the residue detection methods that can be used for cleaners? Does Alconox provide pharmaceutical validation information?

Answer:
A pharmaceutical cleaning validation involves residue detection method selection. Residue detection method selection for cleaners can involve specific methods for specific cleaner ingredients such as; high performance liquid chromatography (HPLC), ion selective electrodes, flame photometry, derivative UV spectroscopy, enzymatic detection and titration, or it can involve non-specific methods that detect the presence of a blend of ingredients such as: total organic carbon, pH, and conductivity. The FDA prefers specific methods, but will accept non-specific methods with adequate rationales for their use. For investigations of failures or action levels, a specific method is usually preferable. The later section of this document lists references to several methods for each cleaner brand.

Yes, Alconox, Inc. has compiled a directory of residue detection methods for all Alconox brand detergents and pharmaceutical cleaning validation information. To access this information, visit http://www.alconox.com/static/section_top/gen_cleanval.asp.

Corrosion Inhibition

Question:
Does Alconox provide any information on corrosion inhibition in Alconox brand cleaners?

Answer:
Yes! Corrosion during cleaning is accelerated by the same things that accelerate cleaning: heat, aggressive chemicals, time, and agitation. In approximate order of importance, to reduce metal corrosion concerns, use less heat, lower pH detergents, shorter cleaning time, and less agitation. In general use the mildest pH detergent to limit metal corrosion. Higher pH detergents such as SOLUJET or DETO-JET have special corrosion inhibitors that allow their use with aluminum. SOLUJET and CITRAJET have inhibitors that allow their use on a broad range of sensitive metals without leaving filming amine residues. In approximate order of importance, in general to reduce plastic corrosion, use less aggressive cleaners that have less solvent or surfactant character or use lower concentrations of those cleaners, use lower cleaning temperatures, use less contact time, and finally use less agitation.

To read more, please visit this page.

Solar Module Manufacturing

Question:
Which Alconox detergents can best clean glass or metal that has a photovoltaic surface?

Answer:
Thin film solar module manufacturing requires scrupulously clean substrates in order to optimize the yield of efficient photovoltaic surface. By optimizing yield, the cost of producing solar electricity can be reduced so that it can reach parity with the cost of producing electricity on the grid as other forms of energy rise cost. Thin film photovoltaic cells are made by vapor deposition of silicon (Si) or Cadmium/Telluride (CdTe) layers on transparent metal oxide coated glass superstrates; or by vapor deposition of copper, indium, gallium selenide (CIGS) on thin metal film. In either case, the glass or metal must be clean and free of particulates and oils that will interfere with proper film deposition and electrically isolated solar cell formation. When glass superstrates are laser scribed to form isolated cells, any particulates on the bare glass or oxide coatings can result in poorly formed scribe barriers that cause short circuits and inefficient performance of the resulting cell. Substrates must be clean before and after laser scribing. Detojet detergent is recommended for use in cleaning glass and coated glass substrates before or after laser etching. Large conveyorized spray and roller brush washing units are used. Citrajet is recommended for metal substrate cleaning. Detojet and Citrajet are available from the global distribution network of Alconox, Inc. dealers.

To read more about Detojet and Citrajet, visit www.alconox.com.

Types of Aqueous Cleaners

Question:
What are the different types of aqueous cleaners?

Answer:
There are mineral-acid cleaners that range in pH from 0-2 which remove heavy scales. Mild acid cleaners that range in pH from 2 – 5 ½ , remove inorganic salts, water, and soluble metal complexes. Neutral cleaners range in pH from 5 ½ 0 8 ½ and remove light oils and small particles. Mild alkaline cleaners range in pH from 8 ½ - 11 and remove oils, particulates and films. Alkaline cleaners range in pH from 11 – 12 ½ and remove oils, fats, and proteins. Corrosive alkaline cleaners that range in pH from 12 ½ - 14 remove heavy grease and soils. The Aqueous Cleaning Handbook p 17

Alconox, Inc. manufactures acid, neutral, mild alkaline and corrosive alkaline cleaners for use in various critical cleaning applications. To read more about Alconox brand cleaners, visit www.alconox.com.

Food contact surface cleaners

Question:
What are two Alconox brand cleaners are low foaming and USDA approved for cleaning food contact surfaces?

Answer:
Alconox, Inc. manufactures cleaners for food contact surfaces with no interfering residues. Citrajet, Low-foaming Liquid Acid Cleaner and Alcojet, Low- Foaming Powdered Detergent are designed for cleaning food contact surfaces.

To learn more about Citrajet, please visit http://www.alconox.com/downloads/pdf/techbull_citrajet.pdf.

To learn more about Alcojet, please visit
http://www.alconox.com/downloads/pdf/techbull_alcojet.pdf.

Cleaning Aluminum with Alconox, Powdered Precision Cleaner

Question:
What are the concerns when cleaning aluminum with Alconox?

Answer:
Alconox is widely used to clean aluminum, however we are aware that on extended contact time (typically measured in days) at elevated temperature, a chelate blush can form on aluminum. A chelate blush is a white crusty irregular deposit of aluminum edetate, a reaction between the aluminum and the chelating agent in Alconox.
When cleaning aluminum, it is assumed that the aluminum has been exposed to air and has formed the typical aluminum oxide layer prior to cleaning. If the aluminum has been recently machined and has oils that protect it from the air, then you can have a very active surface under the oil that will form a dark oxidation with Alconox or just about any uninhibited cleaner when the oil is removed under immersion without any air present to form the more passive aluminum oxide surface before being exposed to the cleaner.
If recently machined aluminum must be cleaned and it cannot be allowed to air passivate, then a cleaner that contains appropriate metasilicate inhibitors such as Solujet, Detojet, Alcojet or Tergajet must be used. With the use of these kinds of cleaners, on machined aluminum that does not have the oxide layer formed yet, you get points of aluminosilicate formed only at active sites on the aluminum surface. You do not get a film of any kind and this does not change the electrical, structural or bonding characteristics of the aluminum and is not generally considered to be a problem.

To learn about Alconox brand cleaners, visit www.alconox.com.

Alcotabs

Question:
What is the shelf life of Alcotabs?

Answer:
The shelf life of ALCOTABS Tablet Pipet Detergent (Mfr. Cat. Nos. 1500-1, 1500) has been increased from 730 days (2 years) to 1095 days (3 years) effective as of May14, 2008. Shelf life extension studies determined that the functionality of the ALCOTABS is consistent for a period in excess of 3 years.

To view the updated technical bulletin, download our PDF.

Safety Issues in Aqueous Cleaning

Question:
What are the safety issues involved when using aqueous cleaners?

Answer:
Worker safety issues with aqueous cleaners involve skin exposure, eye exposure, ingestion, and chronic systemic exposure. It is always necessary to consult the label and MSDS on the cleaner for warnings and safety precautions. Physical safety issues include storage and handling.

All Alconox, Inc. brands are biodegradable, technical bulletins and MSDS are downloadable via www.alconox.com.

To read more about safety issues and aqueous cleaning, the experts at Alconox, Inc have written The Aqueous Cleaning Handbook. To request your copy, visit this page.

Acidic Cleaners

Question:
What is the definition of an acidic cleaner?

Answer:
"An acidic cleaner is defined as an aqueous cleaner that has a pH significantly below 7, typically below a pH of 5.5. Acid cleaners contain acids and often other cleaning ingredients, such as surfactants. Acid cleaners use a mechanism known as "acid stabilization" in which an acid reacts with a soil molecule to create a water soluble molecule and "acid hydrolysis" in which an acid reacts with a soil molecule and breaks it into a smaller water soluble soil." The Aqueous Cleaning Handbook p. 157

Request your copy of the Aqueous Cleaning Handbook here.

Active Ingredients in Detergents

Question:
Do Alconox brand detergents contain active ingredients that may cause health concerns?

Answer:
From a pharmaceutical standpoint, there are no active ingredients in Alconox, Inc. brand detergents. Alconox, Inc. makes no health claims about our cleaners and so there are no active ingredients that have to be disclosed that are responsible for our health claims.

Certainly these are detergents, and all the ingredients used contribute to detergency and so the detergents have 100% active ingredients. This basically means there are no fillers, fragrances, or dyes that do not have detergent functionality. The usage of the word active ingredient here is not a pharmaceutical health claim usage.

For more information about Alconox brand detergents, visit www.alconox.com.

Ultra High Vacuum Compatible Cleaning

Question:
Can Liquinox be used to remove residues from stainless steel for ultra high vacuum compatible cleaning?

Answer:
Yes, Liquinox has been used for cleaning ultra high vacuum equipment as the detergent cleaning step. Use a 1% (10 mL/L) solution in water with such heat as is practical, ideally 40-50 deg C. Rinse very thoroughly with purified water. The key to good ultra high vacuum cleaning is thorough rinsing. If cleaning a small container fill and empty it 6X with high purity rinse water. If there is a running water rinse, expose each are of flooded surface to at least 30 seconds of flooding water. Rinse is a way that allows foam to flow off of the surfaces being rinsed and do not allow foam to congregate if possible. If due to the geometry of the parts being cleaned, foam during rinsing cannot be avoided, then at least rinse until all the foam is gone, and then rinse some more. It may take a while.

For more information on Liquinox, please download our PDF.

Cleaning Validation

Question:
What is involved in a cleaning validation? Does Alconox provide information or support for validation?

Answer:
A cleaning validation is a documented guarantee that cleaning can be performed reliably and repeatedly to meet a predetermined level of cleanliness. It involves testing for acceptable residues on manufacturing surfaces. Cleaning validation is becoming a requirement in the pharmaceutical industry and other industries that adhere to Good Manufacturing Practice (GMP) and Quality Systems Regulations (QSR). Other industries include bio-pharmaceutical, bulk- pharmaceutical, medical device, cosmeceutical, and clinical-diagnostic manufacturing. The validation is specific to detergent and method used for cleaning. -The Aqueous Cleaning Handbook Fourth Ed. p. 105

Yes, the experts at Alconox have written The Aqueous Cleaning Handbook with detailed information about cleaning validations. Copies of the Handbook can be obtained by visiting Alconox.com. Technical Support is also available to assist in cleaning validations.

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

Food Contact Surface Cleaning with Solujet

Question:
Can Solujet be used to clean food contact services?

Answer:
Yes, Solujet is USDA authorized category A1 for use in food contact surface cleaning. Solujet is recommended for cleaning stainless steel, glass, Teflon® and ceramic surfaces. Solujet is a low-foaming detergent which can be used in machine washing, spray washers, ultrasonic machines, and can be used manually if proper skin and eye protection are used.

For more information on Solujet, Low-Foaming Phosphate-Free Liquid Detergent download the Solujet technical bulletin by clicking here.

Cleaning BOD bottles

Question:
Which Alconox cleaners can be used to clean BOD bottles?

Answer:
Alconox manufactures several phosphate-free detergents ideal for cleaning BOD bottles. For manual and ultrasonic cleaning use Liquinox, Critical Cleaning Liquid Detergent. Environmental labs often use EPA standard operating procedure manuals in the course of analyzing environmental samples. Many of these procedures call for a phosphate-free laboratory detergent such as Liquinox. For machine washing, use Solujet, Low Foaming Phosphate-Free Liquid or Tergajet, Low-Foaming Phosphate Free Powder.

To order samples and get more information on phosphate-free detergents, visit www.alconox.com.

Residues best cleaned by acidic cleaners

Question:
What types of residues are best cleaned by acidic cleaners and does Alconox manufacture any acidic cleaners?

Answer:
Amines, alkaloids, amphoteric proteins, starches, carbonates and bicarbonates, metal oxides, and insoluble hydroxides are generally best cleaned by acidic cleaners. Alconox manufactures two acidic cleaners. Citranox, Liquid Acid Cleaner and Detergent, a high emulsifying cleaner, can be used ultrasonically or manually. Citrajet, Low-Foam Liquid Acid Cleaner/Rinse is ideal for spray, CIP, or machine washing.

To learn more about Citranox and Citrajet, please visit www.alconox.com.

Detergent Selection

Question:
What are the key considerations when selecting an aqueous cleaning detergent?

Answer:
Critical cleaning requires careful selection of cleaning chemistry and methods to ensure adequate performance without sacrificing either work safety or benign environmental impact. Key considerations include: Type of substrate, Type of soil, part complexity, level of cleanliness required, manufacturing process, cleaning efficiency, environmental consideration. – The Aqueous Cleaning Handbook Fourth Edition pp 31-33.

Request your copy of the Aqueous Cleaning Handbook here.

Tergajet Ion Chromatography

Question:
Can Ion Chromatography detection method be used for Tergajet?

Answer:
Sodium Ion specific electrodes can be used to detect Tergajet, however very good deionized water must be used and there can be no other significant source of sodium in your system. There is about 28% sodium by weight in Tergajet. Given that sodium is commonly found in fingerprints and many other compounds, this may not be the best method to use. If the substrates are cleaned in a way that would not tend to get outside sources of sodium on them, then this method will certainly work. There is plenty of sodium in Tergajet. Note that there is no potassium in Tergajet. There is almost 30% sodium citrate dihydrate present in Tergajet. This is a good marker for Tergajet.

Please visit http://www.alconox.com/static/section_top/gen_cleanval.asp for a list of residue detection methods.

Undissolved Alconox

Question:
Can using tap water to make a 1% solution of Alconox cause there to be some undissolved Alconox particles?

Answer:
Yes, it is possible that the tap water is very hard water and the undissolved Alconox particles being observed are actually white precipitates of calcium and magnesium carbonate. In extremely hard water (water that is very high in calcium and magnesium content) it would even be recommended to use as high as a 1.3% concentration. This would assure that there is sufficient chelating agent present to tie up the calcium and magnesium to avoid formation of insoluble precipitates of calcium and magnesium. If the problem is hard water, then Alconox recommends using a 1.3% solution of Alconox (390 grams of Alconox +/- 15 grams of Alconox) in 30 L. It may take more than 2 minutes to dissolve, because first the insoluble carbonates are formed, and then the chelating and sequestering agents work on these to react with the calcium and magnesium and eventually the carbonates go back in to solution. It could take as much as 4 minutes. Another solution would be to use softened water, purified water, or to simply dilute the hard water 50/50 with softened or purified water instead of using just hard tap water for the 30 L solution.

To view the technical bulletin for Alconox, Powdered Precision Cleaner please visit http://www.alconox.com/downloads/pdf/techbull_alconox.pdf.

Pharmaceutical Cleaning

Question:
What cleaners does Alconox recommend for cleaning pharmaceutical manufacturing equipment and utensils?

Answer:
Alconox recommends using Solujet, Low foaming phosphate free Liquid or Citrajet, Low Foaming Liquid Acid Cleaner/Rinse. These cleaners are excellent for CIP systems and work at low concentrations. They remove soils such as titanium dioxide, tablet coatings, and petrolatum.

To learn more about Solujet and Citrajet, please visit www.alconox.com.

Medical Device Cleaning

Question:
What are the recommended cleaners for ultrasonic cleaning medical devices?

Answer:
Alconox manufactures high emulsifying cleaners ideal for removing difficult soils from surfaces such as elastomers, plastics, and stainless steel. Alconox recommends using Liquinox, Critical Cleaning Liquid Detergent and Citranox, Liquid Acid Cleaner and Rinse, in a two step ultrasonic process which will remove hydrophobic organic residue, alkaline liable particles and inorganic residues.

For more information on Liquinox and Citranox, please visit www.alconox.com.

IRT

Question:
Are lot traceable Inhibitory Residue Test data available via the internet?

Answer:
Yes. Have the COA for the specific lot on hand, and visit www.alconox.com. If you do not have the COA on hand, you can print it out from the website as well. In the top header, select the product with the right pull down arrow and Inhibitory Residue Test with the left pull down arrow. Follow the instructions and you can print out the IRT data.

Nuclear Cleaning with Alconox, Powdered Precision Cleaner

Question:
Does Alconox decontaminate stainless steel from radioactive contamination?

Answer:Yes, Alconox powder can decontaminate stainless steel of radioactive contamination. The phosphates and chelating agents combined with the wetting agents in Alconox are known to be effective at decontamination. We recommend use of a warm (if practical, otherwise ambient temperature solutions, it just takes longer) 1% (10 g/L or 1.25 oz/gal) solution of Alconox detergent in water for manual or soak cleaning. Do not use any kind of pressure spray or automated cleaning equipment as Alconox is a high foamer. Note that Alconox will bind with radioisotopes and will inhibit separation and waste treatment of the spent cleaning solutions by ion exchange columns. It is better to treat spent cleaning solutions by evaporation than by ion exchange. Sometimes it is necessary to use an anti-foamer in the evaporator depending on the evaporator design and the volume of solution being treated with what other types of waste streams if any.

For more information on Alconox, Powdered Precision Cleaner please read this document.

Cleaning Metaxalene

Question:
Which Alconox detergents would successfully clean Metaxalene?

Answer:
Metaxalene containes amide, ester and ether groups. The solubility is unknown. Alconox recommends using Liquinox or Citranox.

For more information about Liquinox and Citranox, please visit www.alconox.com.

Oil Cleaning with Liquinox

Question:
Does Liquinox have the same oil removing power of Dawn detergent? Will Liquinox remove glycol ether residue?

Answer:
Yes, Liquinox and Dawn contain a blend of nonionic and anionic surfactants. Certain oils are best cleaned by detergents that have mixed micelles of anionic and nonionic surfactants. Using Liquinox in sonication will produce results similar to that of Dawn for oil removal. Liquinox should certainly be able to remove glycol ether residues. Be sure to rinse thoroughly to remove the Liquinox and all other residues.

For information on Liquinox, Crtical Cleaning Liquid Deteregent, please visit http://www.alconox.com/downloads/pdf/techbull_liquinox.pdf.

Cosmetics Cleaning

Question:
What are some cleaning concerns for the Cosmetic industry?

Answer:
Cosmetic manufacturing involves many oils, pigments, emollients, and "waterproof" ingredients. Difficult-to-clean residues include titanium dioxide and silicone oil emollients. For help selecting an appropriate cleaner, request a copy of Alconox Guide to Critical Cleaning at http://www.alconox.com/section_top/m_literature.asp.

How to Use and Restore a pail of solidified Alconox Powdered Precision Cleaner

Question:
Is there any way to restore a pail of Alconox to its original form after it has become solid like a rock?

Answer:
Regretfully, once solidified, the phosphates in Alconox have been hydrolyzed by exposure to water or humidity and then have re-condensed and hydrated to form a phosphate cement. It is certainly possible to scrape and pound to break it up in to chunks and release powder and use these chunks for general purpose cleaning. It is not recommended to use the chunks for critical cleaning. Once the phosphates have hydrolyzed, they are chemically different than the original chemical and will not perform all of the dispersing, chelating and sequestering functions as well as the original formula did. Certainly the hydrolyzed phosphates still have significant detergency, but for the most critical cleaning, do not use the solidified and scraped Alconox.

Alconox should be stored is a closed container in a cool dry place (60 - 90 deg F). Alconox is actually fairly robust and can tolerate a fair amount of excess humidity and moisture, although eventually it will harden.

To view the technical bulletin for Alconox, Powdered Precision Cleaner, click the link http://www.alconox.com/downloads/pdf/techbull_alconox.pdf.

Removal of Tannin from Stainless Steel Equipment

Question:
Which Alconox detergent will clean the red staining of wine (tannin) from stainless steel equipment?

Answer:
The best way to remove tannin is to oxidize it with bleach or an oxidizing agent. There are three Alconox brands that could effectively remove tannin including Detojet, which contains sodium hypochlorite bleach, Alcojet which contains an active chlorine compound that releases hypochlorite when dissovled in water, and Tergajet which contains active oxygen compound that releases peroxide when dissolved in water.

For information on Detojet, Low Foaming Liquid Detergent, Alcojet, Low Foaming Powdered Detergent, or Tergajet, Low-Foaming Phosphate-Free Powder please visit www.alconox.com.

Cleaning Time

Question:
Are there other cleaning variables, besides increasing cleaning time, which would allow for a more thorough cleaning process?

Answer:
At Alconox, Inc we recognize that “While manual cleaning may take minutes, and spray cleaning seconds: soaking may take hours, possibly overnight, to achieve comparable cleanliness.” The Aqueous Cleaning Handbook p 22-23

Yes, cleaning time can be accelerated by increasing temperature, increasing agitation and by the use of a more aggressive detergent. Of course if none of these variables can be changed, perhaps because the substrate is too delicate or the proper equipment unavailable, then be prepared for longer cleaning times. For more information see Chapter 3 of The Aqueous Cleaning Handbook.
To request a free copy of The Aqueous Cleaning Handbook, visit http://www.alconox.com/static/section_customer/book.asp
Or call 914-948-4040 extension 155 to request your free copy!

Cleaning Olanzapine

Question:
Which detergent should be used for manual & CIP cleaning of Olanzapine?

Answer:
Olanzapine has a predicted water solubility of 0.5 mg/mL making is very slightly soluble in water. There are n-heterocyclic groups which means it can be cleaned by either an acid or an alkali, possibly slightly better by an alkali. This is a medium small molecule that is slightly polar and should be emulsifiable. Use Solujet for spray CIP cleaning. Solujet can also be used for manual cleaning (operators have to wear protective gloves & eyewear when handling), although Liquinox would also work for manual cleaning.

To view technical bulletins for Solujet, Low-foaming Phosphate-Free Liquid and Liquinox, Critical- Cleaning Liquid Detergent visit www.alconox.com.

Cleaning with Tergazyme

Question:
How long will the enzyme in a 1% solution of Tergazyme remain active?

Answer:
A 1% Tergazyme solution is designed to give good reliable cleaning performance for 8 hours at 120 deg F. This is designed to correspond to an 8 hour work shift in a hospital. We are confident that after 8 hours there will still be good enzymatic activity as long as you have not exceeded 130 deg F temperatures, so if by chance the Tergazyme solution is not changed or made fresh at the beginning of a shift, it should still provide some cleaning efficiency. We do not recommend routinely using a solution for 16 hours.

For more information about Tergazyme, Enzyme-Active Powdered Detergent, please visit www.alconox.com.

Detergent 8 vs. Alconox, Powdered Precision Cleaner

Question:
What are some differences between using Alconox or using Detergent 8 to remove oily residues from aluminum?

Answer:
Detergent 8 is slightly better at removing oily organic residues, natural ester oils and rosins. However, Alconox is better on particulates and inorganic residues than Detergent 8. Alconox is also effective on oily residues and will work better in hard water than Detergent 8. Use caution when cleaning aluminum. Detergent 8 has a pH of 11.5 which will attack most bare aluminum that has not been anodized or protected. Aluminum can be cleaned safely without attack in pH 9.5 Alconox, however Alconox will very slowly attack aluminum in extended contact time.

To read more about Alconox, powdered precision cleaner and Detergent 8, low foaming Ion-free Detergent visit www.alconox.com and view technical bulletins.

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.