Terminal HEPA Filters – Validation Summary Report (VSR) Template

Validation Summary Report (VSR)

Equipment: Terminal HEPA Filters

Subcategory: Sterile (Injectables/Aseptic)

Area: Engineering

Summary

This Validation Summary Report outlines the validation activities conducted for the Terminal HEPA Filters used in the Sterile (Injectables/Aseptic) area. The report includes details on the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases, along with acceptance criteria based on ISO14644 Annex 1.

Scope and Boundaries

The scope of this validation encompasses the Terminal HEPA Filters installed in the Engineering area, which are critical for maintaining aseptic conditions during the production of sterile injectables. The boundaries include the operational parameters, maintenance procedures, and monitoring protocols relevant to the HEPA filters.

Executed Protocol List

  • Design Qualification (DQ) – Protocol No. DQ-THF-001
  • Installation Qualification (IQ) – Protocol No. IQ-THF-002
  • Operational Qualification (OQ) – Protocol No. OQ-THF-003
  • Performance Qualification (PQ) – Protocol No. PQ-THF-004

Deviations Summary

No deviations were noted during the execution of the validation protocols. All activities were performed as per the approved protocols and acceptance criteria.

CPP Verification Summary

The critical parameters verified during the qualification process included:

  • Integrity leak test
  • Airflow face velocity

All critical parameters met the acceptance criteria as defined in ISO14644 Annex 1.

Conclusion

The validation of the Terminal HEPA Filters has been successfully completed. All DQ, IQ, OQ, and PQ activities were executed in accordance with the established protocols, and all acceptance criteria were met. The equipment is deemed qualified for use in the Sterile (Injectables/Aseptic) area.

See also  Distillation Unit / Distillation Column – OQ Protocol

Attachments Index

  • Attachment 1: DQ Protocol and Report
  • Attachment 2: IQ Protocol and Report
  • Attachment 3: OQ Protocol and Report
  • Attachment 4: PQ Protocol and Report

Approvals

Validated by:

Name: ____________________ Date: _______________

Title: ____________________

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