TechNotes

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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Alconox Inc.’s Director of Technical Marketing and Commercial Development, Michael Moussourakis, sat down at the Oral Solid Dosage Symposium 2017 with Pharma’s Almanac TV’s, Mark Allen, to discuss how globalization is influencing the latest trends on cleaning validation. Click here to watch the video and hear how the growing market for CDMO Cleaning Validation training, and the opportunities in cleaning non-critical single use technology.

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When beginning cleaning validation, a company must identify the residues to be tested and then select the best detection method. Alconox Inc. is here to help. We provide validation service support

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Q: We are advising a mid-sized pharmaceutical company. If we use multiple cleaning agents within a facility, the cleaning program may be a bit difficult to manage (chances are that the operators may use the incorrect cleaning agent for the product) and also the cleaning validation will be a more complex exercise. What would you recommend for general cleaning? Which is preferred between acidic and alkaline cleaning agent to start with?

A: Thank you for your inquiry for a multi use detergent as this is certainly not an uncommon question. Learn more….

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Q: I work for a medical device company where we make machined parts. I’m interested in finding a supplemental visual inspection tool that will aid in inspecting the surface of a part after being cleaned. A: We would recommend getting…..

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Q. How do you determine acceptable residue limits when performing a cleaning validation?

A. All Alconox Inc. cleaners have an oral LD50 of greater than 500 mg/Kg acceptable residue limit. Alconox®, Liquinox® and Citranox® all have an oral LD50 of greater than 5 g/Kg. If you calculate 1/1000 of the LD50 as a potential residue in a dose …

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Q: What precisely is critical cleaning? How does it differ from “regular” cleaning? A: It refers to a very specific type of cleaning. It is where the cleaning itself impacts the value of the finished output from whatever residue/contaminant is being cleaned.

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Q. Does Alconox, Inc. offer validation consultants to provide validation tech support?
A. 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.

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Alconox answers the question; “What is pharmaceutical cleaning validation”? Learn more about compliance with cGMP regulations for all Alconox cleaner brands

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