Critical Cleaning - Alconox, Inc.: October 2008

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General Cleaner Info: Pharmaceutical Cleaning Validation CAP Residue Detection Methods
Catalog	Users Manual

Thursday, October 30, 2008
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.

(Detojet, Low-Foaming Liquid Detergent)

Tuesday, October 28, 2008
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.

(General and Current Good Manufacturing Practice for Finished Pharmaceuticals)

Friday, October 24, 2008
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.

(Chemistry Bath-life extension and control)

Tuesday, October 21, 2008
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.

(Cleaning Ceramic Aluminum Oxide and Polysulfone)

Thursday, October 16, 2008
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.

(Ultrasonic Cleaning with Alconox brand cleaners)

Tuesday, October 14, 2008
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.

(Pharma Cleaning Validation – Swab Limit Calculations)

Thursday, October 09, 2008
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.

(Disposal of Citranox)

Tuesday, October 07, 2008
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.

(Detergent Residue Testing - Conductivity for Alcotabs)

Thursday, October 02, 2008
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.

(Copper Cleaning)