Alexander Hill
By Alexander Hill on December 06, 2021

IES cGMP Process

When a client in the purchasing process has indicated they want a cGMP compliant unit, the first step is to determine the User Requirement Specifications (URS) and ensure the pressure range, temperature range, automation, etc. offered by an IES extractor are in line with what the client is looking for in the system.

Once the URS has been agreed upon, and the sales order has been executed, the purchasing and manufacturing of the system begins. During this process, IES traces the lots of all components used in the manufacturing of the system. Certain critical components require certificates that are also logged in the build. The purpose of this process is to have full traceability of the parts back to their source.

Once the system has been fully assembled, we conduct thorough Factory Acceptance Testing (FAT) which tests the minimum and maximum ranges of the extractors capabilities, ensures the system is operating within acceptable tolerances, performs several simulated runs at common parameters, performs multistage runs between varying solvent densities, all the while cleaning the interior pathways of the extractor.

We then drain, clean, and ship the extractor to the client.


Once the client is ready to have the system commissioned, we arrive on-site and conduct the Installation Qualification, the Operational Qualification, and the Performance Qualification (IQ/OQ/PQ)

The IQ is when the installation technician examines all aspects of the facility and ensures that the equipment has been installed and stored to our specifications.

The OQ is a repeated series of testing that mirrors the testing done during the FAT prior to shipment.

The PQ is the first several live extractions. This is to validate that the system is extracting oil as it is expected to.

This entire process is documented extensively and upon the completion of the entire process, a thorough Turn Over Packet will be handed over to you.

Published by Alexander Hill December 6, 2021
Alexander Hill