10 User requirements specifications Performance Qualification (PQ) Functional specifications Operational Qualification (OQ) Design specifications Installation Qualification (IQ) Verification ‘In operation’ Cleanroom construction Verification ‘At-rest’ Verification ‘As-built’ Qualifying HEPA Filters Pharmaceutical cleanrooms require an extensive validation procedure before initiating pharmaceutical production. The process then has to be revalidated in predefined intervals. For HEPA terminal filtration, this means that there is initial qualification and periodic requalification of its performance characteristics. Qualification Procedure FDA cGMP Guidelines, including Section IV-Buildings and Facilities; Section IX-Validation of Aseptic Processes; and Section X-Laboratory Controls describe the principles of validation and qualification that are applicable to the production of medicinal products. This procedure typically follows a V-shaped model, consisting of three sequential steps (Figure 3). Each of these steps poses its own stringent demands on HVAC installations in general and HEPA filtration specifically. Selecting high quality manufactured HEPA filters will enhance the probability of success in this validation sequence. Installation Qualification (IQ): does the HEPA filter specification match what I had ordered and expected? Examples of HEPA filter requirements: • Individual test report according to IEST-RP-CC001 • Complete and accurate labeling, including serial number for traceability • Correct packaging and testing information Operational Qualification (OQ): does the HEPA filter perform according to functional specifications during ‘at-rest’ operation? Examples of HEPA filter requirements: • Absence of any visual damage to filter media, gasket, and frame • Successful in-situ test result with confirmed filter integrity • Actual initial resistance performance consistent with specification Performance Qualification (PQ): does the HEPA filter demonstrate reliable performance during full-scale operation? Examples of HEPA filter requirements: • Absence of leakage (e.g., media) and bypass (e.g., gasket seal) according to IEST-RP-CC034 • Consistent particulate collection efficiency over time • Absence of fiber shedding that could cause contamination Figure 3: Cleanroom Validation Procedure, Derived from ISO 14644-4
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