In the mechanical engineering and manufacturing industry, the Factory Acceptance Test (FAT) is increasingly gaining importance as a central step in quality assurance. This process allows for a systematic inspection of systems before they leave the manufacturer. Especially in sensitive areas such as the pharmaceutical industry, it is an indispensable tool for systematically meeting the requirements of CGMP as well as the strict specifications of EU-GMP Annex 1.
In the pharmaceutical industry, the FAT is an integral part of preparing for Installation and Operational Qualification (IQ/OQ) according to GMP guidelines. The FAT can (and should) already anticipate parts of the qualification (leveraging – the optimal use of all available resources) to shorten the time on-site (SAT/IQ/OQ). Leveraging serves to increase the efficiency of the subsequent qualification phases.
What is the Factory Acceptance Test?
The Factory Acceptance Test refers to a comprehensive inspection of machines or systems at the manufacturer's plant. During this process, functionality, performance, and compliance with the agreed specifications are tested. However, the FAT is more than just a validation phase that takes place before shipping to the customer; it is rather a quality-assuring testing phase conducted based on the User Requirements Specifications (URS) and the functional specifications. Such tests typically include mechanical, electrical, and software-based components. They are based on detailed requirement lists provided by the client.
In the pharmaceutical industry, where aseptic filling lines such as Blow-Fill-Seal systems are used, this test significantly supports the documentation of compliance within a comprehensive Contamination Control Strategy (CCS). Experts define it as a bridge between production and installation. For Rommelag bottelpack systems, the FAT is crucial as it verifies the seamless integration of the three process steps – forming, filling, and sealing – under aseptic conditions. This ensures that the critical filling zone is locally protected by Grade A UDAF, which forms the basis for subsequent sterile production. It prevents defects from being discovered only on-site. Standards such as ISO 9001 support such procedures through clear quality management specifications.
Achieving Maximum Quality Standards
The central goals of the Factory Acceptance Test lie in ensuring the highest quality standards. Primarily, it aims to identify deviations from specifications at an early stage. This minimizes the risk of expensive rectifications at the site of operation and, at the same time, the test promotes cooperation between the manufacturer and the customer.
In regulated industries, the FAT supports compliance with global standards such as FDA regulations (21 CFR 210/211) and the EU-GMP guidelines. Especially with aseptic BFS systems, commercial sterility and maximum precision are proven before delivery. Furthermore, it serves to optimize operational efficiency through preliminary tests. Such tests contribute to cost control by eliminating the risk of costly reworks or returns after delivery.
The Structured Procedure of an FAT for BFS Systems
The procedure of a Factory Acceptance Test follows a structured sequence that requires careful planning. First, preparation takes place, in which test plans and criteria are defined. Requirements from the User Requirements Specifications (URS) are integrated here. Subsequently, the team sets up the test environment, including the necessary infrastructure.
The machines are operated under simulated conditions to mimic real-world scenarios. During execution, experts verify functions through specific checks such as performance tests or safety checks. Documentation plays a key role, as all results are logged. Deviations are analyzed and resolved, often in the form of iterations.
Customer representatives observe the process, and finally, a report is generated that confirms compliance. In the pharmaceutical industry, such procedures include additional validations according to GMP. Practical examples show that tests for Blow-Fill-Seal systems check the forming, filling, and sealing. Specialists adapt the procedure to the complexity of the system. This creates a secure framework for the handover.
Test Procedure:
- Preparation phase: Definition of test criteria and creation of the protocol.
- Setup: Construction of the test infrastructure with hardware and software.
- Execution: Performance of functional tests, performance measurements, and safety inspections.
- Documentation: Recording of all data and comparison with specifications.
- Completion: Creation of a report and approval by the customer.
Such steps ensure compliance with Container Closure Integrity (CCI) according to EU-GMP Annex 1 already at the manufacturer's plant. The FAT verifies the technical integrity and the sealing parameters of the system as the basis for CCI. Particular attention is paid to the validation of the hermetic seal. In the BFS process, this takes place thermally directly in the mold, meaning the primary packaging leaves the system already tamper-proof. Engineers often integrate automated tools for even more precise measurements. The entire process takes days to weeks depending on the system size. For highly complex systems such as the bottelpack systems from Rommelag, a duration of usually several weeks is to be expected.
Optimize Costs, Minimize Delays, and Identify Risks in Time!
The advantages of the Factory Acceptance Test manifest in several areas of project management. Primarily, it reduces costs because problems are fixed directly at the factory. This eliminates expensive on-site corrections and delays. Another advantage lies in the increase in safety, as risks are recognized early.
In the pharmaceutical industry, it supports compliance with regulatory requirements, which facilitates audits. Customers benefit from higher reliability of the delivered systems, and manufacturers strengthen their position through demonstrated quality. Practical applications also show that for aseptic systems, sterility is secured in advance.
Structured inspections result in detailed documentations that are useful in the long term. Overall, the test contributes to increasing efficiency. Industry standards like ISO benefit from such procedures, as they create a positive cycle in quality assurance.
The Advantages at a Glance:
- Early error detection: Identification of defects before delivery.
- Cost savings: Avoidance of rectifications at the customer's site.
- Quality increase: Ensuring compliance with all specifications.
- Risk reduction: Minimization of potential hazard sources.
- Documentation advantage: Creation of comprehensive reports for future reference.
- Accelerated market access: Through efficient leveraging of FAT results for subsequent qualification (IQ/OQ), commissioning times at the customer site are significantly shortened.
- Validated process reliability: Proof of functionality under Grade A UDAF conditions, whereby the contamination risk is minimized already in the design phase.
The Challenges at a Glance
Challenges of the Factory Acceptance Test arise from the high effort required in preparation. Often, the test requires significant resources, which burdens smaller manufacturers. Another aspect concerns the simulation of real conditions, which cannot always be perfectly replicated. As a result, some problems remain undetected until they reach the site of use.
Logistical challenges arise when customers have to travel. In the pharmaceutical industry, strict GMP requirements increase complexity, and the costs for test facilities can quickly exceed the budget. Delays can occur if iterations become necessary.
Furthermore, experts criticize the dependence on manufacturer environments. Such tests offer no guarantee for long-term performance. Practitioners note that documentation errors lead to misunderstandings. Industries such as mechanical engineering see them as a potential bottleneck, which creates a need for alternative methods.
Challenges and Framework Conditions:
- Extensive resource planning: Requires early coordination of specialist personnel and test media.
- Through the use of original packaging materials and specialized test media, a very high level of realism is achieved.
- Additional costs: Expenses for travel and test materials.