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
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
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.
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.