FACTORY ACCEPTANCE TESTING (FAT) – SURROGATE POWDER TESTING
The Factory Acceptance Testing using surrogate powder is a major project milestone where Flow Sciences’ demonstrates that the containment system design and manufacturing of the enclosure meets the contract, Occupational Exposure Levels (OEL -defined by client facility/protocol), or PO specifications
INSTALLATION QUALIFICATION, OPERATIONAL QUALIFICATION (IQOQ) DOCUMENTATION
All Flow Sciences’ standard 2000 Series Benchtop Vented Enclosures and 10000 Series Top Mount Filtration Containment Enclosures now have Installation Qualification – Operational Qualification (IQOQ) Documentation available.
“Documentation is most important in the regulated world. ‘If it is not documented, it is a rumor’ is a famous saying when dealing with FDA and other agencies. ‘Documentation not available’, or ‘Documentation not adequate’ are most frequently cited deviations in FDA Warning Letters. With a good understanding of the regulations, good science or good engineering it is easily possible to be in compliance with technical requirements. To comply with documentation is not so easy. It is not enough, to have everything documented, it is equally important to have the right documents with the right format. This is where the industry struggles with.” (Source: www.labcompliance.com)
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