Factory Acceptance Test (FAT) for an Industrial Freeze Dryer

Conducting a Factory Acceptance Test (FAT) for an industrial freeze dryer is a critical step to ensure the equipment meets your specific process requirements, safety standards, and URS.

The goal is to identify and fix issues at the supplier's site before the machine is shipped to your facility.

Here is a summary of the essential tests:

1. Static and Document Verification

• Before powering up, ensure the physical build matches the design.

• P&ID and Layout Verification: Check that the physical piping, valves, and components match the Piping and Instrumentation Diagram.

• Material of Construction (MOC): Verify certificates for stainless steel (usually 316L for product-contact parts) and gaskets.

• Welding Inspection: Review boroscope videos of internal piping and chamber welds to ensure there are no crevices.

2. Vacuum and Pressure Tests

The integrity of the vacuum system is the heart of freeze-drying performance.

• Vacuum Leak Test (Pressure Rise Test): The chamber is evacuated, and the rate of pressure rise is measured over time. This ensures the "leak rate" is within acceptable limits. 

  
  

• Ultimate Vacuum Test: Verification that the vacuum pump set can reach the specified minimum pressure within a defined timeframe.

  
  

• Pressure Hold Test: If the unit is designed for Steam-In-Place (SIP), the vessel must be pressurized to confirm it can hold the required steam pressure safely.

3. Thermal Performance Tests

These tests ensure the shelves and condenser can reach and maintain the necessary temperatures.

• Shelf Temperature Pull-down/Heat-up: Measure the time it takes for shelves to go from ambient to the lowest and highest setpoints.

  
  

• Shelf Temperature Uniformity: Using thermocouples on various points of each shelf to ensure there are no "hot" or "cold" spots.

  
  

• Condenser Pull-down: Verify the condenser reaches its target temperature quickly to ensure efficient vapor trapping.

  
  

4. Mechanical and Operational Tests

Shelf Stoppering Test: If your process involves vials, test the hydraulic/mechanical stoppering system to ensure even pressure across all shelves and that no vials are crushed.

CIP/SIP Verification: 

• Clean-In-Place (CIP): Use a riboflavin (fluorescent) spray test to check for "shadow areas" that the cleaning nozzles might miss.

  
  

• Steam-In-Place (SIP): Confirm the system can reach and maintain sterilization temperatures throughout the chamber and condenser.

  
  

• Defrost Cycle: Test the speed and efficiency of the condenser defrosting process.

5. Software and Control Systems

Recipe Management: Verify that custom freeze-drying cycles can be programmed, saved, and executed.

Alarm and Interlock Testing: Deliberately trigger "low vacuum" or "high temperature" scenarios to ensure the system shuts down safely or alerts the operator.

Data Integrity: Confirm that the system accurately records batch data in compliance with 21 CFR Part 11 (audit trails, electronic signatures).