{"id":24497,"date":"2023-08-23T10:46:50","date_gmt":"2023-08-23T09:46:50","guid":{"rendered":"https:\/\/www.hex-group.eu\/hex-consult\/"},"modified":"2023-11-09T10:18:05","modified_gmt":"2023-11-09T09:18:05","slug":"hex-consult","status":"publish","type":"page","link":"https:\/\/www.hex-group.eu\/en_BE\/hex-consult\/","title":{"rendered":"HeX Consult"},"content":{"rendered":"\"HeX\n

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

Cleanrooms require contamination control, and HeX Consult intervenes whatever the nature of the risk. Even in the strictest environments<\/strong>, 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.<\/p>\n

Our expertise in the field also enables us to take a pragmatic approach to the issues, requirements and obligations of cleanroom users<\/strong>.<\/p>\n

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

A comprehensive, high-performance approach<\/p>\n

CONSULTING<\/h2>\n

VALIDATION<\/h3>\n

Master Validation Plan
Protocoles
Risk assessment
Validation Summary Report<\/p>\n

HYGIENE
HOSPITALITY<\/h3>\n

Risk analysis and mapping<\/p>\n

Assistance in preparing visits
accreditations, certifications, external
inspections
Investigation assistance
Drawing up an action plan
Prevalence survey<\/p>\n

QUALIFICATION<\/h3>\n

URS \/ FDS
\nMaster qualification Plan
\nIQ – OQ – PQ protocols
\nRisk assessment
\nQualification Summary Report
\nLinking reports \/ protocols
\nprotocols
\nIQ-OQ-PQ results for release
\nInvestigations & OOS management
\nAction plan and optimization<\/p>\n

MONITORING<\/h3>\n

Monitoring Plan and Procedure
\nRisks assessments
\nTrend analyses
\nPersonnel monitoring
\nEnvironmental monitoring<\/p>\n

QUALITY SYSTEM<\/h3>\n

Change Control
\nStrategy
\nProduction \/ Writing
\nDocumentation system
\n(implementation or update)<\/p>\n

APENDIX<\/h3>\n

HeX Consult supports its
\ncustomers in integrating
\nnew requirements linked to
\nappendix 01 of GMP<\/a> 2022<\/p>\n

Scope of intervention:<\/strong> Premises, Personnel, Equipment, Utilities, EMS, Methods.<\/p>\n

AUDIT \/ INSPECTION<\/h2>\n

HeX provides audit and inspection support:
\nOur approach:
\n– Information gathering, interviews and analysis of practices and behaviors
\n– Audit \/ inspection report
\n– Action, optimization and improvement plan.<\/p>\n

1) On-demand audit<\/h3>\n

\t\t\t\t\t\t\t\t\t\t\t\tIndustrial pharmaceuticals, Biotech, Medtech, Hospital services<\/a><\/p>\n

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

\t\t\t\t\t\t\t\t\t\t\t\tHospital Hygiene<\/a><\/p>\n

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

2) Global audit<\/h3>\n

According to requirements & standards<\/h4>\n

\t\t\tPIC’S PE010
\n\t\t\tPIC’S PE009
\n\t\t\tBPP
\n\t\t\tBPF
\n\t\t\tRoyal Decrees
\n\t\t\tBPPH
\n\t\t\tBPTC
\n\t\t\tCSS \t\t<\/p>\n

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

Tailor-made solutions: Quick audit, full audit or video audit<\/p>\n

Scope Audit<\/h2>\n

FACILITIES & PREMISES
\nEQUIPMENT
\nPERSONNEL
\nUTILITIES
\nFINISHED PRODUCTS
\nRAW MATERIALS<\/p>\n

FORMATION<\/h2>\n

Cleanrooms from A to Z<\/h4>\n

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).<\/p>\n