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Pharmaceutical Cleaning Validation Method References
for Alconox, Inc. Detergents

A pharmaceutical validation for cleaning involves testing for acceptable residues on pharmaceutical manufacturing surfaces. The validation involves pharmaceutical testing for residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, methods validation and recovery studies, and finally writing a procedure and training operators. This procedure is used to document acceptable residues 3 or more times and then a rational monitoring program to maintain a validated state is put in place.
Pharma validations assist with controlling pharmaceutical microbiology, maintenance of pharmaceutical clean rooms, pharmaceutical process validation, and assuring successful selection of pharmaceutical detergent.
Residue identification and detection involves pharmaceutical testing using analytical methods which can be provided by Alconox technical support. The following methods can be used to detect Alconox Cleaners:
Anionic Surfactant HPLC, kit Nonionic Surfactant Derivative UV-vis Direct UV-vis Total Organic Carbon (TOC) Citric Acid by HPLC Conductivity Phosphate titration
Alconox X X X X X
Liquinox X X X X X
Tergazyme X X X X X
Alcojet X X X
Alcotabs X X X X X
Detojet X X
Detergent 8 X
Citranox X X X X X X
Luminox X
Citrajet X X X
Solujet X X X
Tergajet X X X

See the pharmaceutical cleaning validation references for detergent detection method details, including discussion of pharmaceutical testing and setting residue acceptance limits, swab testing, recovery studies and cleaning procedures. Once you reviewed this and decided which methods and procedures you want to use, please contact Alconox for details about the chosen methods and procedures.
To speak to a technical representative about pharmaceutical cleaning validation, call 914-948-4040 for Malcolm McLaughlin or email mmclaughlin@alconox.com.

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