FAT & SAT in Pharmaceutical Industry

Pharmaceuticals is a human-critical industry that widely impacts one's life and well-being. Regulatory bodies have introduced and enforced various checks at different stages of pharma drug manufacturing to ensure quality and safe products. 

Acceptance tests are quality checks performed before any equipment is made part of the production process in a manufacturer's facility to enforce quality in the procured equipment and to make sure the equipment is capable of delivering the quality and efficiency for which the buyer has paid. 

It consists of various tests to check the equipment's current state. It also helps the manufacturer and buyer determine the feasibility of producing the required output and completeness of equipment and detect any discrepancy before the equipment officially becomes part of the production process.  

According to best practices and guidelines, the acceptance test is performed at two locations - at the manufacturer's site, known as Factory Acceptance Test - FAT, and after it has been shifted to the buyer's location, known as Site Acceptance Test - SAT.

Let's briefly discus each

What is a FAT?

Factory Acceptance Test - FAT is a series of tests performed on equipment to verify its design, operation, physical structure, software system and other components according to the agreed specifications. 

FAT is performed at the equipment manufacturer's location before shifting equipment to the buyer's location. Its main aim is to point out any deviations or discrepancies before moving the machine to the buyer's location.

Its importance, apart from regulatory and quality, significant faults or deviations not possible to rectify at the buyer's location, (due to reasons such as unavailability of cortical parts, expertise or simply because the buyer has paid the manufacturer, and it is its responsibility to remove all deviations before shifting to the buyer) can be identified and solved. 

Another main reason is that once shipped, addressing the issues and unique requirements can become costly for the equipment manufacturer and could lead to profit losses. In case of major faults, the buyer rejects the machine, it is costly and difficult to transport the machine back to the machine manufacturer location

The FAT is performed by a comprehensive team from the equipment buyer and comprises members from all critical departments of the buyer pharma organization. 

How FAT is performed?

As mentioned above, FAT is performed at the equipment manufacturer's site. It takes detailed planning and scheduling by the manufacturer and the buyer, summarized below.

• When the buyer finalizes the equipment specifications, the manufacturer provides an estimated timeline for the equipment readiness. If there is any change in the timeline, the manufacturer informs the buyer in advance.

• In the meantime, the buyer and manufacturer both work on the checklist. Any party can prepare it, but in most cases, the machine manufacturer must organize it in an approved and standard format.

• The checklist is prepared based on the agreed specifications of User Requirement Specifications - URS and is reviewed by both parties. 

• Upon completing equipment manufacturing, the manufacturer informs the buyer and prepares for FAT at its location.

• The equipment buyer forms a team to visit the manufacturer's site. The team consists of personnel from all the critical departments that are practically involved and have expertise in machine operation. Typically, personnel from the production, engineering and quality departments must have their viewpoint. During FAT, there is a limitation to including personnel due to travel-related issues. So, it is better to select personnel wisely.

• The team visits the manufacturer's site and performs FAT according to the agreed-upon checklist, which is documented for the final report and future reference. 

• After the test, a report is prepared indicating critical outcomes of the activity, such as tests performed, personnel involved and deviation, if any.  

 What is a SAT?

Site Acceptance Test - SAT is a series of tests performed at the equipment buyer's site after it has been shifted to the buyer's location. Compared to FAT, it consists of additional tests because the machine has now been permanently installed at the buyer's premises with all the requirements and connections, such as piping, electrical connection, pneumatics, and mechanical structure. Due to this reason, more detailed tests are performed during the SAT.

The actual product is used in SAT to check for the machine's success.

SAT is performed after the machine has been installed. The equipment buyer or the machine manufacturer can do the installation. This is decided at earlier stages, such as during the procurement stage.

In contrast to FAT, the machine is provided with all requirements, especially the product. SAT is also helpful in checking for any deviation and discrepancy during transportation. 

It also checks to see if deviations identified during FAT have been resolved or not. 

In some cases, FAT is omitted for reasons such as travelling problems. In this case, the SAT is the main acceptance and testing parameter. 

How SAT is performed?

Like FAT, SAT also requires comprehensive planning from the start and can include the following steps.

• After a successful FAT, agreed upon by both parties, the manufacturer transport equipment to the buyer's location.

• The manufacturer shares details of transportation such as date, shipment number, and carrier to the buyer 

• Upon receiving the machine at the buyer's location, the relevant department, commonly engineering, starts planning its installation. 

• It makes necessary arrangements, such as area, space availability, piping, environmental, electrical and HVAC-related

• They then transfer the machine to its designated location and department, correctly placing it in the designated area.

• The buyer informs the machine manufacturer of the machine placement if the manufacturer is responsible for machine installation according to the agreement. The machine manufacturer makes necessary arrangements, arrives at the buyer's location and performs the machine installation.

• If the buyer is responsible for machine installation, it carefully provides and connects all requirements. It may or may not power up the machine. The manufacturer is informed about the installation. 

• The manufacturer sends the team to be present during SAT. Like FAT, the machine buyer also forms the team and includes personnel from all relevant departments. During SAT, there is no limitation to including many persons in the team, so it is better to include as many persons as possible to allow them to work with the equipment manufacturer and gain expertise & training. 

• The manufacturer's team arrives at the buyer's location and inspects the machine's status. If not installed, they install them. If the buyer installs it, they inspect for any shortcomings and deviations and remove them.

• After installation and inspection, the manufacturer team power up the machine and observe its condition. 

• After necessary checks, the SAT is performed according to the agreed checklists and documented for future reference. 

• All tests mentioned in the SAT protocols are performed. 

• Training is also a part of SAT, where the machine manufacturer trains the designated machine buyer staff in machine operation and maintenance areas. 

• After completion of the SAT, the final report is prepared to finalize and close the SAT.

Documentation

It is necessary to prepare documentation for the FAT and SAT and keep them on record. This is also required and inspected by regulated bodies during their inspection. Commonly, documentation can include

• List of checklist performed during SAT and its report

• List of checklist performed during FAT, and its report

Checklist

As mentioned above, FAT & SAT are performed according to the checklist. It depends upon the mutual agreement on what checks to be included. For an effective machine installation and working, including and performing as many as possible checks within the permissible limit is better.

Some common checks performed during FAT & SAT can include, but not limited to

Documentation: verification that all the required documentation, such as operational, maintenance, and calibration manuals, have been provided

Spare List: It includes the list of spare parts supplied with the machine

Welding records: these include the verification and certificate of a specific welding type in a machine, such as orbital welding for product contact parts

Components Inspection (especially after the machine is installed at the buyer's location): it includes verification that all the required components have been installed and are of the required specifications. For example, make model and output characteristics.

Material of Construction: it includes verification that the specific material has been used in the manufacture of (exact) machine parts

Certificate: it includes all the relevant certificates that have been provided. For example, calibration and material certificates

Installation: it includes verification that the machine has been installed with all of its requirements in the buyer's facility

Utilities: it is the verification that all utilities have been provided with the required specifications. (Such as steam, gasses and compressed air)

Safety (Mechanical and Electrical): All safety devices and interlocks are present and working satisfactorily. 

Automation Components: it is the verification that all automation components, such as PLC, HMI, sensors, and transmitters, have been provided and are working satisfactorily.

Essential Machine Operation verifies that the machine is in working condition and performs its primary task.

Actual Working: when all checks are performed, the machine is operated with actual product and machine parameters to check for its Working, output capacity, any faults and machine behaviour. The machine can be checked for one to three production cycles with actual product and batch length.

About the Author:

Muhammad Asim Niazi

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.