you are a member of a validation team in a multinational pharmaceutical company manu 4450968

You are a member of a Validation team in a Multinational Pharmaceutical company manufacturing sterile products. Your company has recently developed 3 new sterile products, which are now approved for marketing in Europe and the USA, and your site has been chosen to manufacture these products. In order for the company to manufacture these products a new sterile facility will be built. Work on this project is due to commence in Q4 2017. The company has been filling product under aseptic conditions in grade A cleanrooms and now is considering a move to the use of Isolator Systems for the aseptic filling processes. As a result of this, you have been requested to carry out extensive research on Isolator Systems. This research should include a detailed review of the relevant regulations/guidelines (including ISPE Baseline Pharmaceutical Engineering Guide Sterile Manufacturing) and available literature. You will then be required to prepare a paper. The purpose of the paper is to educate your company in the design, integration and use of isolators in the facility. Your paper should consider (but is not limited) to the following, as appropriate: • Design and operation of Isolator Systems • Possible advantages/disadvantages of their use over existing non barrier systems • Outline and review with recommendations of available sterilization processes • Environmental monitoring and integrity testing requirements for the system in operation

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