HEPA Integrity Test System (Photometer + Aerosol Generator) – Equipment Validation SOP

Standard Operating Procedure for Equipment Validation of HEPA Integrity Test System

Purpose: To ensure the HEPA Integrity Test System (Photometer + Aerosol Generator) is validated for its intended use in testing HEPA filter integrity in sterile environments.

Scope: This SOP applies to the validation of the HEPA Integrity Test System used in the Engineering area for sterile (injectables/aseptic) processes.

Definitions:

  • HEPA: High-Efficiency Particulate Air filter.
  • DQ: Design Qualification.
  • IQ: Installation Qualification.
  • OQ: Operational Qualification.
  • PQ: Performance Qualification.

Roles:

  • Validation Team: Responsible for executing the validation process.
  • Quality Assurance: Ensures compliance with regulatory requirements.
  • Engineering: Maintains the equipment and oversees its use.

Lifecycle Procedure:

  1. Design Qualification (DQ): Review design specifications and intended use.
  2. Installation Qualification (IQ): Verify installation per manufacturer’s specifications.
  3. Operational Qualification (OQ): Conduct tests to ensure equipment operates within specified limits.
  4. Performance Qualification (PQ): Not applicable for this equipment.

GDP Controls: Ensure Good Documentation Practices (GDP) are followed throughout the validation process, including proper record-keeping and version control.

Acceptance Criteria Governance: Acceptance criteria shall adhere to ISO 14644 standards for cleanroom environments, ensuring HEPA filter integrity is maintained.

Calibration/PM Governance: The HEPA Integrity Test System shall undergo calibration and preventive maintenance according to the manufacturer’s recommendations and internal procedures.

Change Control Triggers: Any changes in equipment, process, or environment that may affect the HEPA Integrity Test System must initiate a change control process.

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Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or whenever significant changes occur that may impact the system’s performance.

Records/Attachments List:

  • Validation Protocols
  • Validation Reports
  • Calibration Certificates
  • Change Control Documents
  • Maintenance Logs

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