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The Standard Group of Companies is a leading supplier of equipment in the pharmaceutical industry.

The Standard Group offer a full turnkey solution for many products, which includes the design, manufacture, installation and commissioning of these important pieces of equipment.

During the installation process, a multitude of tests need to be completed, correct documentation will be required and provided plus essential training will need to be carried out.

Validation is necessary at 2 key parts of the process which are the site of manufacture and the end user.

Two key testing elements which must be carried out and include: -

  • FAT  - Factory Acceptance Test
  • SAT - Site Acceptance Test

FAT

A FAT, or Factory Acceptance Test is usually preformed at the vendor prior to shipping to a customer.

The supplier tests the system in accordance with the clients approved test plans and specifications to show that system is at a point to be installed and tested on site.

These test plans should have been agreed at the design stage (DQ).

Adequate time must be provisioned, as to complete a full and conclusive FAT, as this will lead to fewer problems when the equipment is installed on site later.

Key parts of a FAT include: -

  • Maintenance and User’s manual
  • Recommended spare parts list
  • Certificate of compliance
  • As built technical drawings
  • Materials certificates
  • Data sheets
  • Main equipment’s data sheets
  • Instruments calibration certificates
  • Welding Processes qualification

SAT

A SAT (Site Acceptance Test) is when the system is tested in accordance to the client approved test plans / specifications, and demonstrate the system is installed properly and interfaces with other systems and peripherals in its working environment.

These tests must be completed with a suitable load that represents the routine day to day activity of the operation.

Key parts of a SAT include: -

  • Finishing Visual check
  • Main components visual check
  • Internal box pressure and ventilation setting
  • Utilities functionality and setting check
  • Functionality/Interlocks Verification (Mechanical & Software)
  • Safety devices and interlocks check
  • Operator’s training

The Standard Group of Companies can provide equipment that will compliment a third-party machine or provide the full turnkey process.formulation isolators granulation isolator 1

The Standard Group will validate all equipment based on customer requirements agreed at the start of the project.

This will always include a satisfactory FAT test, and full SAT support where necessary.

For more information click here or contact with UK and Indian offices directly.