Contact
haut de page

Medtech and medical device

HeX GROUP OFFERS A PERSONALISED, HIGH-QUALITY APPROACH

Our solutions

Is your business subject to rigorous requirements and regulations?

HeX can help you thanks to its COMPREHENSIVE and CUSTOMISED solution: calibration, checks, qualifications, microbiological analyses, validation of methods & processes, consultancy, electronic reports and expertise.

HeX guarantees the highest level of quality and security throughout the process involved in checking your environments and equipment.

Activities

In addition to your maintenance work, HeX takes care of equipment qualification

Microbiological safety cabinet (BSC)

Laminar air flow (LAF) cabinet

Extractor hood

Insulator :
Seal / Confinement | Alarm | Chemical and microbiological decontamination | …

Autoclave, Washer disinfector, Sterilization tunnel, Refrigerator, cold room, incubator, decontamination airlock :
Temperature and/or humidity mapping

Support for document systems (preparation, URS, protocols etc.)

Compressed air :
Oil content | Dew point | Particle | Microbiological

Gas 

Water :
Purified water | Water for injection

Support for document systems (preparation, URS, protocols etc.)

Classification of the air particle cleanliness :
At rest | In operation

Microbiological air and surface controls

Airflow parameter control :
Air speed | Air flow / Air change | Differential pressure

Integrity test on THE filtration

Training :
Knowledge of clean rooms and controlled atmosphere techniques

Support for document systems (preparation, URS, protocols etc.)

Consultancy :
Risk analysis | Sampling plan

Training :
Microbiological controls | Particle classification | Traceability

Distribution :
Validated culture medium | Microbial air sampler | Particle meter

Transportation of your samples

Analyse :
Enumeration | Geonomic identification (up to the pure strain) | Results and help with the statistical analysis

Support for document systems (preparation, URS, protocols etc.)

Consultancy :
Risk analysis | Sampling plan | Choice of strains

Sample collection :
Run of samples (air impaction, surface sedimentation)

Analyse :
Enumeration | Geonomic identification (up to the pure strain) | Results and help with the statistical analysis

Conservation :
Sample library | Strain library | Digital library

Support for document systems (preparation, URS, protocols etc.)

Microbial ecology

Consultancy :
Choice of materials and testing method | Selection of products and consumables | Preparation of validation reports

Training :
Staff clothing and behaviour | Operating practices and methods | Equipment and consumables

Laboratory :
Validation test | Reports and traceability | Fertility test, Validation of neutralizing agents

Validation of H₂O₂ decontamination cycles :
By biological indicator | By chemical indicator | Cycle optimisation

Support for document systems (preparation, URS, protocols etc.)

Sterile products :
Sterility test | Bioburden | Endotoxins | Microbiological stability test

Products that do not have to be sterile :
Contamination control | Antimicrobial conservation | Microbiological stability test

Process and Media Fill Test (methods and/or staff)

Support for document systems (preparation, URS, protocols etc.)

Calibration of control probes and sensors :
Temperature | Humidity | Pressure | CO₂

Full metrology loop :
Probes / sensors / Cables | Cabinets / PCs etc.

Sale of probes and sensors

Support for document systems (preparation, URS, protocols etc.)

80% of tests are
ISO 17020 and/or
17025 compliants