Critical Cleaning - Alconox, Inc.: Cleaning Validation

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

Monday, August 11, 2008

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Cleaning Validation

Question:
What is involved in a cleaning validation? Does Alconox provide information or support for validation?

Answer:
A cleaning validation is a documented guarantee that cleaning can be performed reliably and repeatedly to meet a predetermined level of cleanliness. It involves testing for acceptable residues on manufacturing surfaces. Cleaning validation is becoming a requirement in the pharmaceutical industry and other industries that adhere to Good Manufacturing Practice (GMP) and Quality Systems Regulations (QSR). Other industries include bio-pharmaceutical, bulk- pharmaceutical, medical device, cosmeceutical, and clinical-diagnostic manufacturing. The validation is specific to detergent and method used for cleaning. -The Aqueous Cleaning Handbook Fourth Ed. p. 105

Yes, the experts at Alconox have written The Aqueous Cleaning Handbook with detailed information about cleaning validations. Copies of the Handbook can be obtained by visiting Alconox.com. Technical Support is also available to assist in cleaning validations.

To speak to a technical representative about cleaning validation, call 914-948-4040 for Malcolm McLaughlin (x160) or e-mail mmclaughlin@alconox.com.

(Cleaning Validation)