ViP Definition
"Cleaning Validation is the provision of documented evidence to demonstrate that cleaning processes consistently clean to predetermined limits."
This relatively simple definition can translate into significant and complex programmes of work when applied to manufacturing systems and processes. At ViP, we appreciate the level of this undertaking and have experts who can assist in the development, understanding and implementation of cleaning validation programmes, in areas such as:
- Equipment design reviews
- Matrix approach to cleaning validation for multi product equipment systems, including the identification of marker compounds
- Establishment of acceptable levels of carry-over for residues, including cleaning agents
- Incorporation of equipment hold times into the programme (‘clean’ and ‘dirty’)
- Sampling plans and methods, together with methods of detection
- Composition of Validation Plans, Protocols and Reports
Whatever you need, we can help.
CONTACT US to find out how.
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