HeX Group

About

Experts for over 18 years, HeX offers comprehensive support for your contamination control strategy.

We draw on our many years of experience in cutting-edge, highly demanding sectors: Biotech, Hospital Pharmacy, Medtech, Industrial Pharmacy, MCH, FIV-PMA. We have drawn on the experience of hundreds of customer sites to offer a pragmatic approach to organization, expertise and quality. As we ourselves are confronted with GMP requirements, our experience as users, like our customers, is a strength and a real advantage! That's why HeX can support you throughout the entire contamination control chain: Documentation / Execution - Testing / Protocol validation / Monitoring.

To support you, HeX Group has put in place high value-added human and technical resources, including :
- A technical department,
- A quality department,
- A metrology department,
- A specialized microbiology department,
- A technical and scientific operational team,
- A test traceability system with direct on-site encoding: instant transformation into PDF, available on a secure server with "advanced" electronic signature and meeting 21 CFR Part 11 requirements.
- A laboratory with a high-tech infrastructure: 4.0 fully connected, including a molecular biology department, a BSL2+ biosafety room for surgical mask testing, and a GMP A in B area. Sterility, bio-burden and endotoxin tests are carried out under environmental conditions.

We have been able to put our expertise and experience to work for Safyr, developing a range of solutions including a particle counter (safyr opc) and a Lyra data acquisition and supervision system.

Would you like more information about our services? Please contact us!

Keywords

cleanroom audit, validation & qualification, consulting & training, particle counts, microbiological testing air, surfaces & water, airflow measurements, differential pressures, integrity test for high efficiency filtration, etc

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