Validation Services for GMP Autoclaves

Tender description

The HPA are currently undertaking a capital project to procure, design, install and validate x2 single ended, porous load steam autoclaves. HPA are seeking a competent company to provide a validation services to assist with the installation and validation of these machines. The successful bidder will be expected to be fully conversant with GMP autoclave validation and the creation and execution of all associated validation protocols (e.g FAT, IQ, OQ, PQ) and proven experience in this field. It is required that all relevant test/calibration equipment required to undertake this service will be supplied by the successful bidder. As a minimum, all test equipment would have to be 21 CFR part 11 compliant (secure electronic records etc) where appropriate. Data-logging equipment must be fully validated with documentary evidence. All test equipment used must be calibrated to traceable national/international standards (UKAS standards) with certificate evidence.