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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Q. What is the best way to clean LC/MS glassware?
A. We have published a whitepaper on the formal LC/MS glassware cleaning procedure. Contact us at cleaning@alconox.com for a copy.

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I’m looking for a cleaning solution to use in our industrial ultrasonic cleaner that is similar to the old style competitor detergent. We use it occasionally for general cleaning, removal of machining oils, cleaning for high vacuum use, and to lightly etch the oxides off of copper. 

If we did a pre-mix and let it sit until use, how long would the formulations last before degrading?

Could we also use this mix for washing microfiber towels and foam sponges that have various waxes, polymer sealants and oils on them?

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We are looking for a laboratory dishwasher detergent that does not contain perchlorates. One of our end users analyzes for trace levels of perchlorates, so we cannot have a detergent that has that type of impurities.

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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: We are cleaning heavy scale compounds of Ca, Mg, carbonates, phosphates and organic matter from reverse osmosis (RO) membranes. Can you tell us some cleaning best practices and recommend a detergent?

A. If the organic matter is significant, a two-step process, cleaning by re-circulation or soaking (re-circulation may be more effective) could be needed. If the organic matter is biologic in nature, we would recommend Tergazyme® Enzyme-Active Powdered Detergent which is both a powerful emulsifier along with protein enzymes. If the organic residue is more of an oily nature…

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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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Visit Alconox, Inc. at BIOMEDevice Boston, MA, April 18-19, 2018. Stop by booth #509 to receive our unique gifts, expert technical support for your critical cleaning applications, and detergent samples.

Our critical cleaning detergents remove an array of soils while leaving no interfering residues in applications for medical device reprocessing, medical device manufacturing, lab equipment and glassware, healthcare instruments and more.  

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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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