A specialist pharmaceutical company who focuses on neurology, endocrinology and uro-oncology, recently engaged Banyards to validate their Secondary Clean Room at their facility.
The facility has two clean rooms.
The Primary Suite – is a negative clean room where they manufacture their product, it is a negative suite due to it being a biological product.
The Secondary Suite – is a positive clean room where the secondary product is made, bottled and capped in vials under sterile conditions.
The overall facility is made up of unclassified, clean and sterile areas where we carried out Pre-validation works to ascertain the clean room status. This highlighted a number of items that required addressing to ensure compliance with the different territories to which the pharmaceutical company supplies the products.
As a result of our Pre-Validation findings, we were involved in a number of consultations with the client where we were able to advise on required works to rectify the issues within the time frame to keep in line with production. The required works included filter changes and recommissioning works.
Our commissioning and survey works were conducted in accordance with the current guidelines and regulations including:
The Orange Book design guide.
The Grade “A” air supply as described in PIC/s PI 032-2 (08 January 2010)
Good manufacturing processes (GMP)
Our test sheets and documentation were fully compliant with the Good Manufacturing Process (GMP). Due to our successful Pre-validation, recommissioning, consultation meetings and reporting Banyards have been asked to undertake 4 revisits per year to help maintain and advise the client with the ongoing operation of their facility.
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