Successful Completion of FAT for Biopharmaceutical Enterprise's Filling Machine Exceeds Accuracy Expectations Across Multiple Specifications
Recently, our company welcomed an important delegation-the acceptance team from a biopharmaceutical enterprise. Their visit was aimed at conducting the Factory Acceptance Test (syringe filling machine FAT) for a new high-speed filling machine they had ordered.
During a week of rigorous testing, the equipment successfully passed comprehensive performance validation for two different packaging materials (cartridge and pre-filled syringe) and four different filling volumes (ranging from 0.2ml to 5.0ml). The filling accuracy consistently remained within ±1%, with critical specifications demonstrating even greater stability, exceeding the client's expectations.
01 Meticulous Preparation: A Customized FAT Plan
The Factory Acceptance Test (FAT) is a comprehensive evaluation conducted at the manufacturer's facility prior to equipment delivery. It ensures that the equipment meets technical specifications and user requirements, playing a crucial role in boosting customer confidence, reducing project risks, and ensuring delivery efficiency.
To ensure the smooth execution of this FAT, our technical and project teams engaged in multiple rounds of in-depth communication with the client. Together, we developed a detailed, customized FAT test plan fully aligned with the client's actual production processes and needs.
The plan focused on core elements of utmost importance to the client: material safety, operational stability, filling accuracy, and data integrity. The tests utilized two packaging materials actually used by the client-cartridges and pre-filled syringes-and incorporated four different filling volumes to comprehensively simulate future production scenarios.
02 Rigorous Execution: Multi-Dimensional Validation of Equipment Performance
Material Confirmation and Installation Check: The team first reviewed pharmaceutical-grade material certifications for all parts in contact with the product, ensuring compliance with GMP requirements. Installation conformity was also verified against design drawings.
Performance and Accuracy Testing: This was the core of the FAT. Under high-speed operating conditions, the equipment was tested sequentially with the two packaging materials and four filling volume combinations.
Filling Accuracy: For filling volumes of 1.0ml and above, accuracy was consistently controlled within ±1%.
Operational Stability: Throughout the testing period, the equipment operated smoothly without significant interruptions.
After a week of rigorous and efficient testing, all test items were passed successfully in a single attempt. The client's acceptance team expressed extreme satisfaction with the results. The equipment's performance exceeded expectations, particularly in terms of accuracy stability and operational ease during multi-specification and multi-material changeovers.
The successful completion of this syringe filling machine FAT is a testament to the close collaboration and thorough communication between both teams, as well as a reflection of our company's outstanding comprehensive equipment performance and high-quality standards.
03 About Us
Shanghai ALWELL remains dedicated to providing advanced low-volume filling solutions for global biopharmaceutical companies. Integrating R&D, production, sales, and service, we are committed to in-depth development and progress in this field, offering more competitive, safe, and reliable equipment to pharmaceutical clients worldwide.
