Leak Test Machine (CCIT) – Equipment Validation SOP

Standard Operating Procedure for the Validation of Leak Test Machine in Prefilled Syringes and Cartridges

Purpose

This SOP outlines the validation process for the Leak Test Machine (CCIT) used in the verification of container closure integrity for prefilled syringes and cartridges.

Scope

This procedure applies to the validation of the Leak Test Machine in the Production/QC areas for all products utilizing prefilled syringes and cartridges.

Definitions

  • CCIT: Container Closure Integrity Testing.
  • DQ: Design Qualification.
  • IQ: Installation Qualification.
  • OQ: Operational Qualification.
  • PQ: Performance Qualification.

Roles

  • Validation Team: Responsible for executing the validation protocol.
  • Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
  • Production Personnel: Operate the Leak Test Machine and maintain records.

Lifecycle Procedure

  1. Conduct Design Qualification (DQ) to define user requirements.
  2. Perform Installation Qualification (IQ) to verify installation against specifications.
  3. Execute Operational Qualification (OQ) to ensure the machine operates within specified limits.
  4. Carry out Performance Qualification (PQ) to confirm the machine performs as intended under actual operating conditions.

GDP Controls

Good Documentation Practices (GDP) must be followed throughout the validation process to ensure traceability and compliance with regulatory standards.

Acceptance Criteria Governance

The acceptance criteria for the validation of the Leak Test Machine shall adhere to the User Requirements Specification (URS) and Annex 11 guidelines.

Calibration/PM Governance

The Leak Test Machine must undergo regular calibration and preventive maintenance as per the manufacturer’s specifications and internal quality standards.

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Change Control Triggers

Any changes to the equipment, process, or materials that could impact the validation status must be documented and evaluated through the change control process.

Revalidation Triggers and Periodic Review

The Leak Test Machine will require revalidation every 12 months or upon any significant change in process or equipment.

Records/Attachments List

  • Validation Protocols
  • Validation Reports
  • Calibration Certificates
  • Change Control Documentation
  • Training Records

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