HeX Consult

Backed by 20 years of cleanroom missions and expertise, HeX confirms the “HeX Consult” department and deploys tailor-made support, based on the group’s fundamentals: Quality, Rigor, Performance, Flexibility.

Cleanrooms require contamination control, and HeX Consult intervenes whatever the nature of the risk. Even in the strictest environments, subject to the most stringent regulatory requirements (GMP/BPF), the HeX Consult department can support you thanks to its mastery and expertise in the following fields: Aerospace, Aeronautics, Microelectronics, Pharma, Biotech, Medtech, Medical Devices, Hospital (GMP/BPF) and Hospital Hygiene.

Our expertise in the field also enables us to take a pragmatic approach to the issues, requirements and obligations of cleanroom users.

The many sectors HeX has visited give it a cross-disciplinary vision of the cleanroom field, precise knowledge of standards and agility in handling risk factors and cleanroom optimization.

A comprehensive, high-performance approach

CONSULTING

VALIDATION

Master Validation Plan
Protocoles
Risk assessment
Validation Summary Report

HYGIENE
HOSPITALITY

Risk analysis and mapping

Assistance in preparing visits
accreditations, certifications, external
inspections
Investigation assistance
Drawing up an action plan
Prevalence survey

QUALIFICATION

URS / FDS
Master qualification Plan
IQ – OQ – PQ protocols
Risk assessment
Qualification Summary Report
Linking reports / protocols
protocols
IQ-OQ-PQ results for release
Investigations & OOS management
Action plan and optimization

MONITORING

Monitoring Plan and Procedure
Risks assessments
Trend analyses
Personnel monitoring
Environmental monitoring

QUALITY SYSTEM

Change Control
Strategy
Production / Writing
Documentation system
(implementation or update)

APENDIX

HeX Consult supports its
customers in integrating
new requirements linked to
appendix 01 of GMP 2022

Scope of intervention: Premises, Personnel, Equipment, Utilities, EMS, Methods.

AUDIT / INSPECTION

HeX provides audit and inspection support:
Our approach:
– Information gathering, interviews and analysis of practices and behaviors
– Audit / inspection report
– Action, optimization and improvement plan.

1) On-demand audit

Industrial pharmaceuticals, Biotech, Medtech, Hospital services

– Good laboratory practices in immersion
– Management, handling and entry of consumables and materials under fume hoods,
– Cleaning and disinfection
– Personnel dress and behavior
– Management of equipment and environments
– Good contamination control practices
– Organization of workstations.
– WEO: work extramural ophtalmo
– BSPC: Belgian Society for private clinics (plastic surgery inspection)

Hospital Hygiene

– Controlling the risk of infection
– Processing and sterilization of surgical instruments
– Reprocessing of heat-sensitive endocavitary devices used in operating rooms, urology, gastroenterology
intensive care units, etc.
– Reprocessing of heat-sensitive devices: endocavitary ultrasound probes, transoesophageal ultrasound probes, etc.
– Management of invasive devices during care: peripheral venous catheters / implantable chambers / indwelling urinary catheters
– Medication flow, from prescription to dispensing
– Procedure in the event of an epidemic
– Management of patients on additional precautions (air, contact, droplets)
– Personnel
– Observance of hand hygiene in care departments and operating theatres
– Biocleaning practices in operating theatres, high-risk wards and care departments
– HACCP procedures in catering
RABC in laundry
– Waste sorting procedures
– Ergonomics at the workstation, assistance with workplace accident analysis, mapping of professional risks, drafting of single document

2) Global audit

According to requirements & standards

PIC'S PE010

PIC'S PE009

BPP

BPF

Royal Decrees

BPPH

BPTC

CSS

In addition to the audit/inspection report, we support you in the study of optimizations and submit action plans.

Tailor-made solutions: Quick audit, full audit or video audit

Scope Audit

FACILITIES & PREMISES
EQUIPMENT
PERSONNEL
UTILITIES
FINISHED PRODUCTS
RAW MATERIALS

FORMATION

Cleanrooms from A to Z

17 training modules adapted to your standards, whether hospital (PIC/S PE010 – Royal Decrees 30/09/20 – CCS etc.) or pharmaceutical (GMP/BPF – PIC/S PE09).

A: Introduction: Cleanrooms and contamination control
B: Cleanroom quality management (GMP / PICs)
C: Validation, Qualification and Monitoring: the fundamental GMP triptych
D: Risk analysis: a necessary way of thinking
E: Cleanroom equipment: essential and critical
F: Qualification of cleanroom premises and environments
G : L'assurance qualité des résultats dans les GMP / PICs
H: PEOPLE in cleanrooms: qualifications, behavior and clothing
I: Surface control in cleanrooms GMP / PICs