Kneat Blog

The Difference Between a FAT and a SAT

Posted by Kneat Solutions on 29-Jun-2017 09:05:09

shutterstock_244570873.jpg

It’s a question commonly asked in the validation arena, what is the difference between a FAT and a SAT. This article will finally explain what the difference is and why each one is required.

Any project that involves equipment being developed from a third party should have a FAT and SAT incorporated into the system life-cycle. If both the FAT and SAT are performed correctly is will lead to a much easier IQ/OQ process.

What is a FAT

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

It’s an essential aspect of the whole system lifecycle and should be performed by experienced personnel. Time spent doing a proper FAT will lead to fewer problems when the equipment is installed on your site.

ISPE verdict:

The partial commissioning and qualification of equipment and/or systems prior to their shipment from the fabricator’s site.

Publication Source: ISPE Biopharmaceutical Manufacturing Facilities Baseline® Guide

GAMP verdict:

Factory Acceptance Test (FAT): (IEEE) An Acceptance Test in the Supplier’s factory, usually involving the Customer.

Publication Source: GAMP 4, Good Automated Manufacturing Practice Guide for Validation of Automated Systems.

On acceptance of a FAT some items to look out for include:

  • Performed FAT Protocol
  • Maintenance and User’s manual
  • Recommended spare parts list
  • Certificate of compliance
  • As built technical drawings (electrical, mechanical, pneumatic & process schemes)
  • Materials certificates/data sheets
  • Main equipment’s data sheets
  • Instruments calibration certificates
  • Welding Processes qualification

What is a SAT

A SAT is a Site Acceptance Test the system is tested in accordance to client approved test plans and specifications to show the system is installed properly and interfaces with other systems and peripherals in its working environment.

ISPE verdict:

Inspection and /or dynamic testing of the systems or major system components to support the qualification of an equipment system conducted and documented at the manufacturing site.

Publication Source: ISPE Commissioning and Qualification Baseline® Guide (March 2001)

Below is a list of some items that should be considered when performing a SAT:

  • 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
     

 See how Kneat can help with your digital transformation!

 

 

Topics: Validation

Kneat Solutions Blog

Our next generation productivity software makes your Validation and Manufacturing processes paperless, more compliant and centrally managed.

Our customers are seeing productivity increase by more than 100% and cycle times reduced by more than 50%, leading to improved OEE.

Read about their results 

Subscribe to Email Updates

Recent Posts