TechNotes

Q. We are moving from LD50 data to ADE (PDE) limits based on HBELs. This is allowing us to eliminate disposables for low-risk products.  How do I know which can be manually cleaned and which needs to be in a washer? Can manual cleaning be validated?

A. Many pharma and biotech companies have been moving to Health-Based Exposure Limits (HBELs) meaning Acceptable Daily Exposure (ADE) or Permitted Daily Exposure (PDE) limits as detergent residue limits.    

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Your detergents have corresponding biocompatibility data. Our medical devices must be pyrogen and endotoxin free. Someone mentioned that biocompatibility tested detergents, like yours, will be free of organic residues like endotoxins and pyrogens. Is this true?

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Q: We are looking for detergent and process recommendations for manual cleaning of a 100 gallon mixer. We make one product in the mixer which contains water, modified food starch, acidic buffers, sucralose and preservative. Currently when cleaning, we boil for 1 hour at 90°C, then cool, drain and soak in cool water while using the mixing blades.  Scrub brushes and a spray hosing follows that. The mixer is made from stainless steel.

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Q: Can you tell me if Liquinox can clean/remove pharmaceutical probiotics? We use this product to clean our packaging lines. We have a customer who is looking to have us package their probiotic product.

A: Liquinox® Critical Cleaning Liquid Detergent is an excellent emulsifier of organic and oily residues. It will do the job. Best practice, however, would be to incorporate a powerful emulsifier of organic and oily residues, along with enhanced protein removal. 

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Q: We are a mid sized small biomolecule drug manufacturer and currently use several Alconox, Inc. products in our cleanroom and manufacturing suites.  We are looking at implement (functionally) closed bioprocessing.  Are there any recommendations you can provide?
A: Some time ago, I heard a senior executive of a large biotech company express a desire to produce drugs in a “conference room.”  That day is pretty much here. 

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We are cleaning a V Mixer made of NSF Stainless steel and we are using it to mix different protein powders, amino acids, and herbs for dietary supplements. It is small enough to be cleaned by hand but not small enough for any type of sink. I was advised to buy your Citranox product. Is that the best detergent for this job?  

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Q. We manufacture vitamins, which include minerals (calcium, magnesium etc.) and have found that Citranox is very effective in cleaning the residue left in our equipment. Unfortunately, we have learned that the pH of Citranox is too low for our local requirements. Do you have another detergent with a higher pH that would work equally as well?

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Find answers to questions such as: What is ultrasonic tank cleaning? Which industries employ? What Alconox brands are ideal for ultrasonic tank cleaning?

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Q. I am a validation manager and we use Liquinox in multiple pieces of equipment across our manufacturing site. While witnessing our cleaning, I noticed the dilution instructions are not being followed. Instead, operators are adding some squirts/pumps/pours from the bottle into a bucket with purified water. Does Liquinox have a range of effective concentration?  Do you have auto-mix ideas or other dosing solutions for customers facing this issue of accurate formulation?

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Q. I’m a Ph.D. student and I’m studying protein interactions. We have been using Tergazyme to clean lenses and cuvettes for our light scattering equipment and it works flawlessly! My question is: Does Tergazyme enzyme detergent have any disinfection properties, like killing of bacteria such as E. coli?

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