1. Equipment Basic Function Verification

Filling Accuracy and Speed

• Confirm that filling volume accuracy (±1%) meets process requirements; test consistency across different specifications (e.g., 0.5 mL, 1 mL).

• Verify maximum and minimum filling speeds to ensure they meet specifications; evaluate the impact of speed variation on accuracy.

Seal Integrity Testing

• Inspect seal integrity of prefilled syringes after filling (e.g., plunger and needle seals) to prevent leakage or contamination risks.

Sterile Barrier System

• Confirm the integrity of sterile isolators or RABS (Restricted Access Barrier Systems), including differential pressure and particle monitoring.

2. GMP Compliance Checks

Materials and Surface Finishes

• Product-contact components (e.g., filling needles, fluid transfer tubing) must be made of 316L stainless steel and medical-grade silicone, meeting sterility requirements.

Cleaning and Sterilization Validation

• Verify CIP (Clean-in-Place) and SIP (Sterilize-in-Place) functionality to ensure no dead legs, with residue and microbial limits conforming to standards.

Data Integrity

• Confirm that the control system (e.g., PLC) supports traceability, is tamper-proof, and has a fully functional audit trail.

3. Automation and Control Systems

Human-Machine Interface (HMI)

• Verify user-friendliness of the operation interface; ensure completeness of parameter setting, alarm logging, and fault diagnosis functions.

Sensors and Feedback

• Check sensitivity and reliability of critical sensors (e.g., liquid level detection, tube absence detection leading to fill stop).

Batch Records and Electronic Signatures

• Ensure automatic generation of batch reports with support for electronic signatures.

4. Safety and Risk Control

Mechanical Safety

• Validate emergency stop buttons, interlocked safety doors, anti-pinch designs, etc.

Biosafety

• High-risk areas (e.g., filling needle zone) must have biosafety protection (e.g., laminar airflow containment).

Deviation Handling

• Simulate common faults (e.g., filling volume deviation, missing stopper) and confirm the effectiveness of alarm and automatic rejection mechanisms.

5. Documentation and Supplier Support

Technical Documentation Review

• Check completeness of equipment manuals, DQ/IQ/OQ/PQ templates, spare parts list, material certificates, etc.

Supplier Services

• Confirm that the supplier provides training and maintenance support, with clearly defined response times.

6. Environmental and Utility Compatibility

Utility Interface Verification

• Validate compatibility between equipment and facility utilities (e.g., water, electricity, compressed air, nitrogen), including pressure and purity requirements.

Environmental Monitoring

• Test the impact of equipment operation on cleanroom environment (e.g., airborne particle counts).

7. Simulated Production Testing

Worst-Case Condition Challenge

• Test equipment stability under extreme conditions (e.g., minimum speed, highest viscosity drug solution).

Continuous Operation Test

• Conduct a 72-hour continuous run to evaluate equipment reliability and failure rate.

8. Regulatory and Standard Compliance

Ensure equipment complies with the following standards:

• GMP requirements

• ISO 9001

Notes

• User Involvement: Production, Quality, and Engineering departments must participate throughout the FAT (Factory Acceptance Test) to ensure all requirements are covered.

• Risk-Based Prioritization: Prioritize testing of high-risk items (e.g., sterility assurance, data integrity).

• Record Retention: All test data and deviation reports must be archived as the basis for subsequent SAT (Site Acceptance Test).