Contact
top

YOUR EXPERT
IN TRAINING
AND CONSULTING

YOUR EXPERT IN TRAINING AND CONSULTING

HeX consult offers extensive experience in the control of critical environments.

HeX consult can offer you support through specialised training courses and/or consultancy services.

The HeX consult training course programme is always designed to meet customer requirements. Here you will find topics and content that will enable you both to increase your knowledge and apply what you have learnt in practice in your work.

HeX Consult training courses can be delivered within a company or among a group to companies. HeX consult can also provide a friendly, comfortable training room. Various modules are available

4 H

How to carry out specific metering?

Designed for staff required to carry out routine controls (hospital pharmacy, human body materials bank “IVF, MAP” or hospital hygiene team)

  • method ISO 14644-1 (2015)
  • ISO 14644-1 (2015) and GMP classes
  • using the meter
  • practical exercise
  • status
  • evaluation (if required)
4 H

Good practice in microbiological controls:
passive air (sedimentation), active air (impaction), surfaces (contact plate) and use of sterile gloves

Designed for staff required to carry out routine controls (hospital pharmacy, human body materials bank “IVF, MAP” or hospital hygiene team)

  • method ISO 14698
  • hospital targets and GMP classes
  • choice of consumables
  • use of the biocollector
  • practical exercise
  • status
  • evaluation (if required)
4 H

How to ensure traceability of your specific and microbiological controls?

Designed for staff required to carry out routine controls (hospital pharmacy, human body materials bank “IVF, MAP” or hospital hygiene team)

  • requirements of the standards (ISO) and GMP
  • record sheets
  • continuity with the microbiological analysis laboratory
  • practical exercise
  • evaluation (if required)
1,5 j

Cross-discipline and summarised cleanroom training course:
hospital, laboratory and hospital pharmacy sectors

Technical resources, control, qualification & preventive maintenance

Course also included in the training course programme of the training and skills centre.
For further information, please contact Mrs Sandrine Vanaubel.

  • Module 1: Cleanroom (bio)
    • History
    • Definitions and vocabulary
    • Basis of microbiology and bicocontamination
  • Module 2: Controlled environment

    Aerobiocontamination

    • Properties of air
    • Sources

    Control of air quality: regulatory aspect

    • Reference standards
      1. EN ISO 14644
      2. EN ISO 14 698
      3. GMP
      4. NF S 90-351
      5. CSS advice No. 8573
    • Technical prevention methods
      1. Particle cleanliness
      2. Microbiological cleanliness of air
      3. Cleanroom design (flows, flow rates, pressure, filtration)
      4. Management of flows

    Control of air quality: technical aspect

    • Technical maintenance
      1. Technical maintenance
      2. State of cleanliness
      3. Filter system
    • Monitoring programme
      1. Control and operation programme
      2. Test report
      3. Traceability

    Specific case: Hospital pharmacy

    • Reference standards
      1. PIC/S
      2. Royal decree of 28/09/09
      3. Filter system
    • Qualifications and validations
      1. Different types of qualifications
      2. Controls, measurement and tests QC, QI, QO, QP
    • Traceability
  • Module 3: Control of the quality of surfaces
    • Equipment and materials
    • Contamination of surfaces
    • Methods and procedures
    • Cleaning and disinfection plan
    • Controls
  • Module 4 : Cleanroom behaviour
    • Man, the source of biocontamination
    • Cleaanroom behaviour
    • Staff hygiene
    • Clothing
    • Strict adherence to protocols, initial and ongoing training
1 à
6 j*

Complete cross-discipline cleanroom training course

Various modules developed by specialists in each aspect of the cleanroom in order to provide an exhaustive response to a complex subject.

Course only available at the training and skills centre.
For further information, please contact Mrs Sandrine Vanaubel.

*Course valid for 1 to 6 days depending on the modules selected.

2 j

Quality in the laboratory: practical application of standard ISO 17025

Course also included in the training course programme of the training and skills centre

Interpretation of the requirements of standard ISO 17025, identification of the documentation and technical requirements and translation of the requirements into a laboratory quality system.

  • Main concepts of Quality
  • ISO 17025 accreditation
  • Requirements of the standard ISO 17025
  • The parties involved in the test/calibration laboratory
  • Practical exercises / Questionnaire / Questions

Our specialists will try to provide support through their roles as consultants and experts. HeX consult can provide studies, analyses or the presence of a HeX specialist at one of your meetings.

HeX Consult expertise

  • Contamination control (particle and microbiological) in critical environments
  • Hygiene, behaviour and microbiology of the environment
  • Quality (accreditation standards associated with the laboratory's technical expertise: ISO 17025, ISO 17020)
  • Metrology of tests in critical environments such as cleanrooms
  • Design and arrangement of cleanrooms
  • Techniques in particular for the ventilation of a cleanroom

HeX Consult Profiles

Tony WATTRELOT

  • Co-founder of the HeX Group operating in BeNeLux and France
  • More than 10 years of experience of controls in critical environments, in particular cleanrooms
  • Specialist cleanroom training provider for more than 5 years
  • Part-time lecturer in air hygiene and the biocontamination of controlled environments at USTL (Lille 1)
  • Participation in numerous articles, seminars and conferences as a cleanroom specialist
  • Assistance to owners in the renovation or construction of hospitals or drug manufacturing plants
  • Degree in biology and degree in safety and quality in the delivery of care
  • Accreditation of the HeX Group test laboratories under ISO 17025 and inspection body under ISO 17020

David DENEUVILLE

  • Co-founder of the HeX Group operating in BeNeLux and France
  • 4 years' design studio experience: Design, manufacture, installation, refurbishment of air treatment systems, HVAC networks, cooling towers, etc.
  • More than 12 years of experience of controls in critical environments, in particular cleanrooms
  • Preparation of test and inspection protocols, planning, monitoring of work, supervision of operatives in cleanrooms and controlled environments
  • Assistance to owners in the renovation or construction of hospitals or drug manufacturing plants
  • University diploma in mechanical and production engineering, self-taught in the control and monitoring of particle, biological and chemical contamination

Franck POLYN

  • HeX Lab Director
  • Director of the Lille Pasteur Institute laboratories for 8 years
  • Change implementation and transition management
  • 20 years of expertise in the field of controlled hospital environments and hospital hygiene procedures
  • Expertise reports on biocides, disinfection procedures and Medical Devices
  • Expert roles in hospital hygiene (France, Africa, Asia)
  • Participation in the drafting of cleanroom guides and reference manuals
  • Master's degree in health engineering
  • Accreditation of the Lille Pasteur Institute Laboratories under ISO 17025

Pauline LEGRAND

  • Quality Manager for the HeX Group operating in BeNeLux and France
  • Responsible for HeX accreditations: test laboratories under ISO 17025 and inspection body under ISO 17020
  • 7 years' experience in the introduction and management of an accredited documentation system
  • 7 years of experience of controls in controlled critical environments, in particular cleanrooms
  • Assistance and consultancy in the conduct of an ISO 17025 and ISO 17020 or ISO 9001 certification project.
  • Conduct of internal and external audits (client of supplier) in accordance with the applicable reference standards
  • Degree in Food Hygiene Safety and Quality

Thomas PHILIPPE

  • 12 years' experience in calibration and thermal mapping on site and in the laboratory under ISO 17025 accreditation
  • Including 8 years managing teams
  • Responsible for development projects accreditation deputy
  • Defence of BELAC thermometry technical audit
  • Responsible for accreditation of CO2 concentration measurements in accordance with ISO 17025
  • Graduate in electromechanical engineering and technical training at LNE, CETIAT & LBT

Need help?

Request a callback for free

[X] Close