• May 24, 2024

Site acceptance test in the pharmaceutical industry is performed at the buyer’s site to verify equipment performance, before taking equipment for routine operations.

Site Acceptance Test in the pharmaceutical industry is an integral part of commissioning activities and verfies the entire equipment performance before taking it into routine operation. In SAT, equipment is tested for all functions, working, and output against the desired acceptance criteria. This acceptance test is conducted at the buyer’s location by connecting all the necessary utilities, implementing actual production parameters, and applying real-time operational scenarios.

During SAT, representatives of equipment manufacturers are also present. They aim to observe the entire SAT activity and aid equipment installation. They also monitor the SAT activity and help resolve deviations or discrepancies.

Position of Site Acceptance Test in the pharmaceutical industry

Site Acceptance Test is part of the commissioning activities and is performed after Factory Acceptance Test has been completed at the manufacturer’s location.

After completion of SAT, equipment validation in pharmaceutical industry commences before equipment is officially handed over for production.

site acceptance test in pharmaceutical industry is performed at buyer's location to verify equipment operation before taking it into routine operation
Site acceptance test in the pharmaceutical industry is performed at the buyer’s location to verify equipment operation before taking it into routine operation

Importance of Site Acceptance Test in the pharmaceutical industry

Let’s discuss the importance of Site Acceptance Test in the pharmaceutical industry.

Helps to identify deviation during transportation and installation

Site Acceptance Test in the pharmaceutical industry is used to verify any deviation, part mismatch, or missed part during transportation. Because, for transportation, equipment is dismantled at the manufacturer’s location and sent to the buyer’s site. Chances are that some parts can become damaged, faulty, or missed during machine transportation. In this case, the equipment will not perform according to the desired acceptance criteria.

Similarly, during equipment installation at the manufacturer’s site, chances are that the machine can be wrongly installed and thus will not perform according to the requirements.

In this case, the SAT helps detect any damage or missing parts during transportation and installation.

Follow–up to Factory Acceptance Test

SAT also is a follow-up to the factory acceptance test to verify un-completed tests, deviations, and amendments, if required. Sometimes, there is a limitation at the manufacturer’s site during FAT in pharmaceutical industry, such as time, test product, or resources.

As described above, SAT is performed at the buyer’s location, which is often free of limitation, and acts as a verification tool to check and verify any leftover processes and tests.

Alternative to Factory Acceptance Test

Sometimes, the FAT in pharmaceutical industry is omitted and only SAT. This can become inevitable due to many such as time limitations or in an emergency where the buyer’s company representative can’t travel to the manufacturer’s location. Site Acceptance Test is the only preferred and available solution in this scenario.

Maximum participation of buyer’s personnel and training

Site Acceptance Test enables maximum participation of buyer’s personnel and associated staff. It allows the utilization of every personnel’s expertise and skills in performing the SAT, which helps in maximum exposure and training for the team.

Realistic operational parameters

During SAT, it is possible to apply realistic operational parameters and actual products to verify and observe the machine’s performance, which is impossible during factory acceptance tests. Because during FAT, only a limited quantity of product can be transported to the equipment manufacturer’s location. This can pose a limitation in creating actual operating scenarios.

Additionally, it is much easier to create a desired operating environment, such as temperature and humidity, at the buyer’s site than at the manufacturer’s location.

Regulatory requirement

Site Acceptance Test is a regulatory requirement for every new equipment. The pharma product manufacturer is bound to perform SAT and complete all the associated documentation production equipment.

Regulatory bodies review the SAT documentation and can issue a warning or suspend production operations if SAT is not performed.

Format for Site Acceptance Test in the pharmaceutical industry

Format for Site Acceptance Test can be same as that of Factory Acceptance test, or it can be changed. It depends on the requirements of equipment or a pharmaceutical organization.

An example of the format is mentioned below.

Test Acceptance Criteria Pass / Fail Signature with date

 

  • Test: The verification performed on the equipment for a particular part, process, section, or function.
  • Acceptance Criteria: it is the recommended outcome of the test, agreed upon during the procurement stage.
  • Pass / Fail: Either the test is passed or failed, depending upon the acceptance criteria
  • Signature with Date: Personnel signature with date, who has executed the process.

 

Checklist for Site Acceptance Test in the pharmaceutical industry

The checklist for Site Acceptance Test can be similar to Factory Acceptance Test because the equipment is tested for the same performance parameters.

Checklist for Site Acceptance Test consists of various test related to machine operation
The checklist for Site Acceptance Test consists of various tests related to machine operation

For the SAT, the following checklist can be used.

Installation

In this test, personnel verifies that the equipment is installed according to the manufacturer’s requirements and completes the entire specification. Some checks that can be verified include the following.

  • Utilities – such as Power, Steam, Compressed Air, and different gases
  • Environments – such as Temperature, Humidity, and Pressure
  • Area Clearance – the sufficient area is provided for man, machine, and material movement

Performance

It includes machine operation and performance tests for which the buyer intends to purchase the equipment. Some checks include but are not limited to

  • Temperature Control System
  • Pressure control
  • Flowrate
  • Output product characteristics
  • Motion control system

Calibration

It includes tests to verify that all the required measuring instruments and devices are calibrated, and certificates are provided.

Documentation

It includes tests to verify that the necessary documents have been provided. Some documents can include the following.

  • User Manual
  • Validation documents
  • Calibration certificates
  • Software design specifications
  • Hardware design specification
  • Drawings
  • Spare part list
  • Electrical drawings

 

Safety

It includes tests to verify the safety system of equipment. Some tests can include the following.

  • Emergency stop button
  • Temperature safety system
  • Pressure safety system
  • Machine Guarding
  • Human safety system

 

Training

It verifies that essential training is given to different departmental personnel, enabling them to operate, maintain and face the emergency situation for an effective production process. It can include the following.

  • Identifying each part correctly.
  • Equipment operation
  • Maintenance
  • Safety systems

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