Before taking control of pharma equipment from the manufacturer, the buyer performs acceptance tests to verify its features, effectiveness, and working. This article discusses types of acceptance tests in the pharma industry.
Acceptance tests are a series of tests performed by the pharma equipment buyer before officially manufacturing a product. There are various types of acceptance tests in the pharmaceutical industry and, includes FAT & SAT
The primary purpose of types of acceptance is to ensure that all the requirements have been incorporated into the equipment by the machine manufacturer and meet the requirements of the equipment buyer. After the success of acceptance tests, the equipment can perform and produce a product for which that particular equipment has been purchased.
Like other pharma processes, equipment procurement in the pharmaceutical industry is a regulated activity. A pharma product manufacturer must go through a series of steps when deciding and planning to procure new equipment. Without following and implementing these steps, regulatory bodies can issue a warning, impose a fine, or even shut down manufacturing operations until the manufacturer fulfills the requirements.
Role of types of acceptance tests in the equipment life cycle
Acceptance tests are performed at the commissioning stage of the equipment life cycle. They are performed in two phases – after the equipment has been manufactured and installed at the buyer’s facility. Commissioning verifies that the equipment.
- Includes all the buyer’s requirement
- Functions according to the needs and expectations of the buyer
- Is handed over to the buyer in working condition
- Commissioning facilitates the equipment’s qualification process.
After the success of the commissioning activities, the next stage is pharmaceutical equipment validation, which is the final stage before manufacturing the product on the equipment.
What are the criteria for types of acceptance tests?
Before executing the test, its acceptance criteria are defined. The acceptance criteria are the design requirements for which a particular test is considered to pass or fail.
A Design Qualification document defines the acceptance criteria during the design phase.
The equipment manufacturer keeps these acceptance criteria in mind during equipment manufacturing. The equipment manufacturer is also bound to adhere to these acceptance criteria. Otherwise, acceptance tests are rejected by the equipment buyer.
For pharmaceutical equipment, acceptance criteria should include and cover all aspects, functions, and sections of pharma equipment manufactured for the buyer.
Examples of acceptance criteria for pharma equipment that must be included in the acceptance tests include the following.
- Computer
- Software
- Human-machine interface
- Instrumentation systems
- Utility requirements
- Materials of construction
- Safety and alarm system
- Equipment capacity
- Documentation requirement
- Operational parameters
Types of Acceptance Tests
In the commissioning stage, commonly, there are two types of acceptance tests – Factory Acceptance Test (FAT) and Site Acceptance Test (SA).
Factory Acceptance Test – FAT
The fat in pharmaceutical industry is performed at the equipment’s manufacturer location. The equipment manufacturer arranges the machine’s operation with actual product characteristics and specifications. The equipment buyer also sends a team to check and verify the equipment’s operation. The FAT team consists of personnel from production, engineering, and quality.
If the equipment’s operation is according to the manufacturer’s requirements, the fat in pharmaceutical industry is said to be passed. The equipment is shipped to the buyer’s location for further testing, such as Site Acceptance tests and pharmaceutical equipment validation.
If the equipment’s specification is not according to the manufacturer’s requirements, the FAT is said to be failed. The equipment’s manufacturer is responsible for removing the deviation. If deviations and discrepancies are severe, FAT is repeated before proceeding to the next stage. Otherwise, deviations can be verified during SAT stage.
The entire FAT activity is documented. It consists of a series of a checklist in a documented form. Each checklist is performed and verified against its respective acceptance criteria. If the test fulfils the acceptance criteria, the test is considered a pass. Otherwise, it is a failure.
After the conclusion of the FAT activity, a report is prepared. It indicates the current status, further actions and their respective timeline. Equipment is shipped to the buyer’s location depending on the satisfactory FAT result.
Site Acceptance Test – SAT
Site Acceptance Test is performed at the buyer’s location after FAT is completed at the equipment manufacturer’s location. In this test, the buyer installs the equipment at its site, with all the requirements such as Utilities, Power, and HVAC system. The equipment is run with real-time parameters and the actual product. If, during the test, there are any deviations, it is recorded, and it becomes the responsibility of the equipment manufacturer to work closely with the equipment buyer to remove the deviations.
The equipment manufacturer sends its team to participate in and oversee the entire SAT activity- from equipment installation to the final report.
The actual product is used to verify the machine’s performance during the SAT. Typically three cycles of actual production with real-time equipment parameters are executed.
Like FAT, SAT is a documented activity with a series of checklists. Every test has its acceptance criteria, agreed upon during the design phase. If SAT passes all the acceptance criteria, SAT is considered a pass. Otherwise, SAT failed, and a further line of action is discussed.
After a successful SAT, a final report is prepared. It mentions detailed SAT working, results, and personnel involved. The equipment manufacturer also carries out training for the equipment buyer personnel, and a training report is also prepared.
Conclusion
Acceptance tests are an integral part of the equipment commissioning stage. It helps evaluate the equipment‘s performance and expectations before it goes into the production stream. Additionally, regulatory bodies, such as the United States FDA and the ISO, use these activities as critical metrics in approving the pharma manufacturing facility. Additionally, regulatory bodies also use acceptance test activities to check and verify pharma manufacturers’ willingness to fulfill regulatory requirements.