By Gil Bismuth

Providing a close, step by step advisor to construction a compliant cleansing validation application, cleansing Validation: a realistic technique covers tendencies up to speed, approaches, cleansing brokers and instruments, sampling strategies, analytical tools, and regulatory concerns. the writer offers sensible examples, database codecs, commonplace working tactics, paintings directions, protocols, and experiences. He offers readers the instruments they should improve a good and conceivable software that won't merely be appropriate to either US and non-US regulatory professionals yet will preserve an organization's time, funds, and folks assets.

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Avoid microbiological contamination by use of purified water at final rinse and heat drying. • Avoid contamination between the CIP system and the equipment by using automated back flow prevention valves. Documentation The documentation of the cleaning procedure is essential. The cleaning philosophy of the company should be reflected through this document and expressed in a simple yet detailed way to the operator. The cleaning procedure must be simple, clear, precise, and documented in a way that helps the operator to execute the cleaning in a reproducible and safe manner.

Since a larger batch is processed in larger equipment, the equipment with the larger surface area represents the worst case. Hard-to-Clean Locations The issue of the homogeneity of dispersion of residues has been discussed and the potential for pockets of residual products in poorly accessible parts of certain types of 40 Cleaning Validation-A Practical Approach processing equipment has been stressed (Mendenhall, 1989). The "best case scenario" described by Agalloco in his theory of dispersion would be represented by freely soluble residues-as in solution formulations-as opposed to the "worst case scenario" represented by a low-level residue in solid dosage forms.

In order to reduce the analytical workload involved in testing all the permutations of the manufacturing sequences, products 38 Cleaning Validation-A Practical Approach and equipment are grouped into families and the worst case is selected in each family. The matrix and worst-case approaches are invaluable in establishing a manageable cleaning validation program. The matrix approach enables the use of a representative product or equipment out of all products or equipment grouped according to similarities.

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