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YOUR EXPERT
IN CRITICAL
ENVIRONMENT CONTROL

HeX Control operates in critical environments where contamination management is a natural requirement (clean rooms and controlled environments) as well as in environments with non-specific pollution (offices, buildings open to the public, housing, etc).

HeX Control réalise des essais sur site (la plupart sous portée d’accréditation) et les résultats sont ensuite analysés afin d'apporter une solution complète au client. Cette mission nécessite une connaissance parfaite du champ d'application et l'expertise répond à ces besoins.

HeX Control considère depuis plus de 15 ans que les contrôles de l’environnement doivent s'intégrer dans une approche globale de la maîtrise du risque.

For over 15 years HEX has been of the opinion that environmental control
should be part of a comprehensive approach to risk management.

HeX
CONTROL
offers
a whole
range of
tests

HeX CONTROL
offers a whole range of tests

Particulate cleanliness of air

Particle counting and classification

Decontamination kinetics and recovery time

Airflow measurement

Air speeds, air flows and calculation of mixture and renewal rates

Differential pressure measurements

FILTRATION

Mesurement of pressure drops in filters

Integrity testing on the filter terminal or housing using an aerosol photometer (EMERY) or a particle counter (DEHS)

Testing on isolators

Enclosure leakage test (leakage rate)

Functional tests (pressure reading and alarm verification)

Detection of leaks from containment enclosures ISO 14644-3

Extractor hood containment and reliability testing EN 14175

Air quality sampling (chemical pollution of indoor air by aldehydes and VOCs) ISO 16200-2

Leak testing of airflow networks EN 12237 & EN 1507

Testing of compressed air valve

Content of solid particles

Control of viable particles

Respiratory mask efficiency testing
(fit-test Portacount) EN 559

Schéma aéraulique et visualisation des flux d’air

Ambience parameters

Temperature, Hygrometry

Sound and light levels

Premises and containment enclosure mapping

Climatic and thermal enclosures

Refrigerator, freezer, oven, incubator, storeroom, environmental chambers
Oven, heat tunnel
Heating plate, thermocycler (PCR)
Freeze-dryer

Autoclave validation

Steriliser validation

Measurement ranges covered by accreditation

-196°C ➙ 155°C
5% HR ➙ 95% HR

Microbiological quality

Microbiological AIR sampling at rest and operational

By impaction
By sedimentation

Microbiological analysis (CFU counting and identification under accreditation BELAC)

Microbiological Contact plates At rest and Operational

Above-floor surfaces, worktops and handling areas
Microbiological analysis (CFU counting and identification under accreditation BELAC)
Sterile garments
Ventilation units and ducts
Gloves

Microbioligical sampling of medical equipment such as endoscopes EN 11737, Ph

Water sampling (microbiological, physical-chemical and endotoxin sampling)

Water for food use
Water for standard treatments
Microbiologically controlled water
Hot water
Water for hydrotherapy pools
Water for hot tubs and hydromassage showers
Water for haemodialysis
Purified water
Highly purified water
Water for use in drinking fountains

Validation of the bio-decontamination cycle and distribution of the
(chemical) sterilising agent on SAS or Pass-box isolator

Inspections of clean facilities

Water for injectable preparations (pharmacopées: PE; USP; JP)


Purified water (pharmacopées: PE; USP; JP)


Clean steam (pharmacopées: PE; USP; JP)


Compressed air valves (ISO 8573 and GMP/BPF targets)
IN THE PROCESS OF BELAC ACCREDITATION

HeX CONTROL
operates
in
numerous
sectors

HeX CONTROL
operates in numerous sectors

Healthcare institutions

Operating theatres

Sterilisation

Hospital pharmacies

IVF – ART – Andrology

Tissue banks

Haematology

Oncology

Pneumology

Angiography

Endoscopy

Neonatology

Intensive care unit

Dialysis

Maternity

Medical biology laboratory

Pharmaceutical Industry

Controlled environment production areas

QA and QC

Tertiairy

Offices and air quality inside homes

Industry

Automotive

Nuclear

Aerospace

Microelectronics

HeX CONTROL
operates
in a large
number of
facilities

HeX CONTROL
operates in a large number of facilities

Premises and environment

Premises for patients

Operating rooms

Sterile or non-sterile medicine production or preparation zones

h3>Equipment

Type I, IIa, IIb and III Microbioligical Safety Cabinets

Vertical and horizontal laminar flow

Isolators

Extractor hoods (Sorbonne)

Recirculation or filtration hoods (ETRAF)

Weighing cabinets

RABS

Freeze-drying tunnels

Respiratory masks

HeX Control carries out tests in a wide variety of environmental and occupational conditions

Active

During the production or preparation of medicines. HeX has established asepsia management procedures during active tests

Passive

With no activity taking place and with ventillation systems, in particular, in operation

After construction work

Without the equipment and consumables in place but with the facilities, particularly venitlation, in operation