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Influences on Pharmaceutical Cleaning Validation

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.

Detecting Residue in Cleaning Validation

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

Determining Acceptable Residue Limits

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 …

Medical Device Cleaning Validation Consultant

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.

What is Pharmaceutical Cleaning Validation?

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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