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.