This is a comprehensive, practical and hands on course based on current aseptic techniques related to working in a clean room and isolator environment.The course includes microbiological monitoring, sampling, testing, validation, identiﬁcation methods and techniques.
Choosing a validation process for reusable devices should rely on guidance from the FDA and validation methods developed by AAMI, as well as International Standards (ISO, ANSI).
Cleaning is the first critical step in reprocessing reusable medical devices.
International Conference on Harmonization (ICH) guidance ICH Q9 (1) encourages that a quality risk management approach be considered and that, based on the level of risk, cleaning processes may be subject to different levels of validation or verification.
This article covers cleaning validation of equipment dedicated to the production of a single API; equipment used for manufacturing a class of products (e.g., penicillins) should be considered as shared equipment and is not addressed here.
Generally speaking, when one thinks of cleaning validation, the first thing that comes to mind is “prevention of cross-contamination”, which obviously applies only when equipment is used for manufacturing more than one product.
So why is cleaning validation talked about with regard to dedicated equipment?Section 12.70 of the guideline ICH Q7, states that, “Cleaning procedures should normally be validated.In general, cleaning validation should be directed to situations or process steps where contamination or carryover of materials poses the greatest risk to API quality…” (2).Download brochure here Read more This 2-day course gives a detailed introduction to the upstream operations in a biopharmaceutical production process used in the development of recombinant protein for human therapeutic use.Cleaning of pharmaceutical equipment is essential to reduce the risk of product contamination and, as stated in relevant guidelines and as recognized by the pharmaceutical sector, this can be achieved only if the cleaning procedure has been validated.The advent of CIP was a boon to industries that needed frequent internal cleaning of their processes.