Successful FAT Completion for Biopharmaceutical Client — Multi-Format Filling Accuracy Far Exceeds Expectations
Recently, our company welcomed an important visitor — the acceptance team from a leading biopharmaceutical enterprise. Their mission: to conduct Factory Acceptance Testing (FAT) on the newly ordered high-speed filling machine.
Over the course of a rigorous one-week testing period, the equipment successfully passed comprehensive performance verification across two different types of primary packaging (cartridge vials and pre-filled syringes) and four distinct fill volumes (ranging from 0.2 ml to 5.0 ml). The filling accuracy consistently achieved within ±1%, with key specifications demonstrating exceptional stability — significantly surpassing customer expectations.
01 Thorough Preparation: Customized FAT Plan
Factory Acceptance Testing (FAT) is a critical step conducted at the manufacturer’s facility prior to equipment delivery. It ensures that the system fully complies with technical specifications and user requirements, playing a vital role in building client confidence, minimizing project risks, and ensuring efficient handover.
To guarantee a smooth and successful FAT process, our technical and project teams held multiple in-depth discussions with the client beforehand. Based on the customer’s actual production processes and operational needs, we jointly developed a detailed, customized FAT test protocol.
The plan focused on core concerns such as:
Material safety
Operational stability
Filling precision
Data integrity
Real-world materials were used during testing: cartridge vials and pre-filled syringe injectors, with four different fill volumes set to comprehensively simulate future production scenarios.
02 Rigorous Execution: Multi-Dimensional Performance Validation
Material Verification & Installation Inspection
The team first reviewed certification documents for all product-contact materials, confirming compliance with pharmaceutical-grade standards and GMP requirements. Equipment installation was then verified against engineering drawings to ensure correctness and completeness.
Performance & Accuracy Testing (Core Focus of FAT)
Under high-speed operating conditions, the machine was tested across all combinations of:
2 package types
4 fill volumes
Key results included:
? Filling Accuracy
For fill volumes of 1.0 ml and above, accuracy was stably maintained within ±1%.
Even at lower volumes (e.g., 0.2 ml), repeatability remained excellent, exceeding industry benchmarks.
? Operational Stability
The machine operated smoothly throughout the entire test cycle.
No significant jamming or downtime occurred, demonstrating robust mechanical design and control logic.
After one week of rigorous and efficient testing, all test items were passed on the first attempt. The client’s acceptance team expressed great satisfaction with the results.
"The equipment performance exceeded our expectations — especially in terms of filling accuracy consistency and ease of operation during changeovers between multiple formats."
This successful FAT outcome was made possible by close collaboration and transparent communication between both teams, reflecting not only the superior integrated performance of our equipment but also our commitment to delivering high-quality, reliable solutions.
03 About Us
Shanghai Yaoshun Precision Machinery Co., Ltd. is dedicated to providing advanced small-dose liquid filling solutions for biopharmaceutical companies worldwide. As an integrated provider encompassing R&D, manufacturing, sales, and after-sales service, we are committed to deep specialization and continuous innovation in the field of precision filling technology.
We strive to deliver more competitive, safe, and trustworthy equipment to pharmaceutical clients globally.
