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YOUR LABORATORY
EXPERT IN
ANALYSING YOUR
CRITICAL PROCESS

YOUR LABORATORY EXPERT IN ANALYSING YOUR CRITICAL PROCESS

As part of your compliance with GMP requirements, PIC’S PE10, Good Cell Therapy Practices, Tissue Bank, Good IVF / MAP, Hospital Pharmacy Practices, NFS 90-351, Superior Health Council …

HeX LAB processes and analyzes all your microbiological samples related to the control of the biocontamination of crititical environments (industrial and pharmaceutical cleanrooms and healthcare establishments …).

HeX LAB supports you in validating the effectiveness of decontamination, disinfection and sterilization equipment (autoclaves, washer-disinfectors, waste sorting systems, Vaporized disinfection processes, sterilization and disinfection cycles, etc.).

HeX LAB conducts microbiological tests on medical devices, medicines, cosmetics and biocides.

HeX LAB participates in microbiological expertise audits in the event of contamination incidents (industrial manufacturing, nosocomial infections, etc.) by performing laboratory tests.

HeX LAB
offers
you a
range
of tests

HeX LAB
offers you a range of tests

Microbiological analysis of biocontamination samples (air and surfaces)

HeX Lab enumerates and identifies micro-organismes in air and surface samples in healthcare institutions, pharmaceutical industries and all other managed environments

Microbiological analysis of clean water samples and physical-chemical analysis of water

HeX Lab enumerates and identifies micro-organisms in water samples from healthcare institutions and water used in industrial processes*

HeX Lab réalise l’analyse physico-chimique d’eau

*Analyzes on "purified water", "highly purified water" and "water for injection" as described in Ph. Eur. Analyzes outside the scope of accreditation


Water system: Decree 21/01/2010, Royal Decree of 14/01/2002

Water for standard treatments: Water guide (2002), CSS n°8364

Domestic hot water: Decree CSH 7509 (2002), Decree of 1st February 2010 - Method: NF T90-431

Water for Hydrotherapy pools: Royal Decree of 14/01/2002, Decree of 18/01/2002

Spa water: Royal Decree of 14/01/2002,) Water Guide (2002)

Bacteriologically controlled water: Water Guide (2002), CSS n°8364

Water for dialysis: European Pharmacopoeia 6.3, USP and JP

Purified Water (European Pharmacopoeia 6.3) USP and JP

Water for Injectable Preparations (European Pharmacopoeia 6.3) USP and JP

Highly purified water (European Pharmacopoeia 6.3)

Microbiological analysis of samples from woven and non-woven linen

Sterility tests on woven and non-woven sterile linen. Pharmacopoeia 2.6.1 microbiologically controlled sterile linen, sterile linen

Microbiological testing of potentially infectious healthcare waste

Statutory quarterly carrier testing, validation of new devices according to NF X 30-503

Microbiological analysis of samples from endoscopic invasive medical devices

HeX Lab samples the microbiological quality of endoscopes after dissinfection (DGS/DHOS, CTINILS – March 2007, CSS n°8355), after storage in a cubourd or EDC(Endoscope Drying Cabinet)(NF EN 16442)

Example of endoscopic invasive medical device: Gastroscope, pneumoscopes, sterile cavity endoscopes

HeX CONTROL is competent to carry out microbiological sampling of endoscopic invasive medical devices.

Microbiological sampling of Medical Devices

Estimation and validation of the bioburden (EN ISO 11737.1)

Testing and validation of sterility (Pharmacopoeia 2.6.1 and EN ISO 11737.2)

Measuring bacterial endotoxins (Pharmacopoeia 2.6.14)

Microbiological sampling of Cosmetics

Detection of micro-organisms (EN ISO 18415)

Assessment of antimicrobial protection (EN ISO 11930)

Enumeration of bacteria (EN ISO 21149)

Enumeration of yeasts and moulds (EN ISO 16212)

Detection of Staphylococcus aureus (EN ISO 22718)

Detection of Pseudomonas aeruginosa (EN ISO 22717)

Detection of Candida albicans (EN ISO 18416)

Detection of Escherichia coli (EN ISO 21150)

Microbiological sampling of pharmaceutical products

Microbiological sampling of non-sterile products (Pharmacopée 2.6.12 and Pharmacopée 2.6.13)

Sterility testing and validation (Pharmacopée 2.6.1)

Measurement of bacterial endotoxins (Pharmacopée 2.6.14)

Microbiological measurement of antibiotics (Pharmacopée 2.7.2)

Antimicrobial conservation (Pharmacopée 5.1.3)


Identification of microbial strains

Macroscopic, microscopic, biochemical and serological method

Efficacy of biocides in the human health, veterinary, food processing and community sectors

Bactericidal, levuricidal, fungicidal, sporicidal and mycobactericidal activity:

Basic standard: EN 1040, EN 1275, EN 14347

Phase 2/1 medical biocides: EN 13727, EN 13624, EN 14348

Phase 2/2 medical biocides: EN 14561, EN 14562, EN 14563

Phase 2/1 agrifood, industry and community biocides: EN 1276, EN 1650, EN 13704, EN 13610

Phase 2/2 agrifood, industry and community biocides: EN 13697

Phase 2/1 veterinary biocides: EN 1656, EN 1657, EN 14204

Phase 2/2 veterinary biocides: EN 14349, EN 16438, EN 16347

Water treatment biocides: EN 13623

Bacteriostatic activity, Minimal Inhibitory Concentration (MIC)

Validation of bioactive materials

Antibacterial surface and textile activity according to internation standards (ISO 22 196 and ISO 846, European (EN2205), American (AATCC 100 and 147) and Japanese (JIS Z 2801)

Validation of sterilisation
and decontamination processes (NF EN 866-1)

Analysis (incubation, reading and interpretation) of bio-indicators for decontamination and sterilization.

Validation of washer-disinfecters

Validation testing of washer-disinfecters of hospital bed pans,
endoscopes and medical and surgical instruments according to NF EN ISO 15883

Validation of processes of disinfection by aerial way

Validation testing of the diffusing apparatus/product pair
according to NFT 72 281 : 2014

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