Equipment cleaning pharmaceutical manufacturing

In the design of equipment for the manufacture of sterile ophthalmic (and nonophthalmic) pharmaceuticals, manufacturers and equipment suppliers are turning to the advanced technology in use in the dairy and aerospace industries, where such concepts as CIP (clean-in-place), COP (clean-out-of-place), automatic heliarc welding, and electropolishing have been in use for several years. As a guide here, the reader is referred to the so-called 3A Standards of the dairy industry issued by the U.S. Public Health Service [267],... 

The same factors also apply to sanitizing agents used to wipe down cleaned equipment. For example, it is a quite common practice to wipe down equipment used to manufacture nonsterile pharmaceuticals with isopropyl alcohol (IPA) subsequent to cleaning the equipment. This final IPA wipedown can be a source of contamination if the IPA is not subsequently removed. Although IPA is fairly volatile, it can pool in the intricate surfaces of a closed... 

CFR 211.67, Code of Federal Regulations PART 211—Current Good Manufacturing Practice for Finished Pharmaceuticals—Equipment cleaning and maintenance, Subpart D—Equipment. 

These guidehnes aim to give guidance to inspectors of pharmaceutical manufacturing facilities and manufacturers of pharmaceutical products on the requirements for validation. The main part covers the general principles of validation and qualification. In addition to the main part, appendices on validation and qualification (e.g. cleaning, computer and computerized systems, equipment, utilities and systems, and analytical methods) are included. 

All necessary activities and responsibilities for the qualification and validation are controlled and specified in this Validation Master Plan. Every step of the described validation program for facilities, equipment, processes, process controls, and cleaning is in accordance with the current European Community Guidelines for GMP and FDA, and the cGMP guideline for finished pharmaceutical manufacturers. All requirements in these directives are fulfilled in this validation process. 

Strege, M.A. Kozerski, J. Juarbe, N. Mahoney, P., At-Une quantitative ion mobility speetrometry for direet analysis of swabs for pharmaceutical manufacturing equipment cleaning verification. Ana/. Chem. 2008, 80,3040-3044. 

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