HEPA Integrity Test System (Photometer + Aerosol Generator) – Validation Summary Report (VSR) Template

Validation Summary Report

Equipment: HEPA Integrity Test System (Photometer + Aerosol Generator)

Subcategory: Sterile (Injectables/Aseptic)

Area: Engineering

DQ/IQ/OQ/PQ Flags:
  • Design Qualification (DQ): Yes
  • Installation Qualification (IQ): Yes
  • Operational Qualification (OQ): Yes
  • Performance Qualification (PQ): No
Acceptance Criteria Reference:

ISO14644

Key Critical Parameters:

Aerosol concentration scan method pass/fail criteria

Requalification Frequency:

12 Months

Summary

This Validation Summary Report outlines the validation activities performed for the HEPA Integrity Test System used in sterile (injectables/aseptic) processes within the Engineering area. The report includes the executed protocols and details on compliance with ISO14644 standards.

Scope/Boundaries

The scope of this validation encompasses the installation and operational qualifications of the HEPA Integrity Test System, focusing on its application in maintaining sterile conditions during the manufacturing of injectable products. The boundaries include all operational parameters defined in the executed protocols.

Executed Protocol List

  • DQ Protocol: HEPA Integrity Test System DQ Report
  • IQ Protocol: HEPA Integrity Test System IQ Report
  • OQ Protocol: HEPA Integrity Test System OQ Report

Deviations Summary

No deviations were encountered during the execution of the DQ, IQ, and OQ protocols. All critical parameters were met as per the defined acceptance criteria.

CPP Verification Summary

Critical Process Parameters (CPPs) were verified during the OQ phase. The aerosol concentration scan method demonstrated compliance with the pass/fail criteria as specified in the acceptance criteria.

Conclusion

The HEPA Integrity Test System has successfully passed all qualification stages (DQ, IQ, OQ) and is deemed suitable for use in sterile (injectables/aseptic) manufacturing processes. The system will require requalification every 12 months to ensure ongoing compliance with ISO14644 standards.

See also  Suppository Base Melting Vessel (Jacketed SS) – Qualification Certificate Template

Attachments Index

  • Attachment 1: HEPA Integrity Test System DQ Report
  • Attachment 2: HEPA Integrity Test System IQ Report
  • Attachment 3: HEPA Integrity Test System OQ Report

Approvals

This report has been reviewed and approved by the following personnel:

  • _________________________ (Name, Title, Date)
  • _________________________ (Name, Title, Date)

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