As a specialist in clean and sterile processes, STERIGENE offers a qualification service for your production facilities to ensure an efficient performance of your machine fleet.
A complete qualification service for your production equipment
The STERIGENE qualification service ensures efficient and accurate monitoring of your installation, whatever the type of process equipment: pharmaceutical autoclaves, washers, inspection machines, BFS, filling or even production and distribution networks of pure fluids.
For this, the STERIGENE team can establish two types of protocols :
• standard protocols in accordance with the manufacturer’s recommendations
• or customised protocols in accordance with your specifications.
In order to report on the operation of your process equipment, our technicians, who use COFRAC traceable equipment, work directly on site. A summary of the work carried out is given to you at the end of the service. The results are then processed and validated by our qualification service team, and the final report is sent to you as soon as possible.
STERIGENE, spécialiste des procédés propres et stériles, met à votre disposition un service de qualifications de vos équipements de production afin de vous assurer une efficacité des performances de votre parc machines
Various qualification services for your process equipment
STERIGENE, because of its expertise in process equipment and clean rooms, can offer several types of qualification so as to meet all your requirements.
• Equipment calibration (CAL):
The purpose of equipment calibration is to control all the measuring instruments (pressure, temperature, time, conductivity …) of the process equipment so as to verify compliance with the specifications defined by the characteristics of the instrument ( accuracy within the range …) by the client (specific requirement, protocol …)
• Installation Qualification (IQ):
Verifying the compliance of an installationagainst the qualified project specifications. Qualified personnel, on the basis of approved protocols, carry out the dimensional inspection of the presence and assembly of various components, testing of the operating system’s software hardware configuration and the inspection of equipment documentation …
• Operational Qualification (OQ):
The purpose of OQ is to check the basic functional compliance of a piece of machinery in its environment. Authorised personnel on the basis of approved protocols and security control different functions of the machine.
• Performance Qualification (PQ):
The objective of the performance qualification is to provide documented proof of compliance with the required performance (defined by the client). For an autoclave, qualification includes the machine, the set cycle, the defined load and its positioning.
• Steam Performance Qualification (Steam PQ)
Determining the steam quality according to the EN285 standard.Checking the quality (dryness) of the overheated non-condensable gases (CNG) and steam condensate analysis (endotoxins, conductivity, micro-organism concentration).
If you would like further information about our qualification services, please contact us by email at sterigene@sterigene.com or by telephone on +33 (0) 1 34 44 23 23.