Clean Room Panels and Equipments
Pharmaco Global’s cleanroom equipment for pharmaceutical applications forms the foundation of controlled environments, enabling precise regulation of air quality, pressure, temperature, and contamination levels. These GMP cleanroom systems are built using modular panel construction with smooth, non-porous surfaces and are designed to integrate seamlessly with HVAC and filtration systems.
Used across sterile manufacturing areas, research laboratories, and quality control zones, these pharmaceutical cleanroom solutions ensure consistent contamination control and stable environmental conditions. With durable construction and low-maintenance design, they support long-term operational reliability, inspection readiness, and compliance with stringent pharmaceutical manufacturing standards.
Frequently Asked Questions
GMP cleanroom panels are prefabricated sandwich-construction wall and ceiling panels with epoxy- or PVC-coated steel face sheets enclosing PUF/PIR, honeycomb, or mineral wool cores. Non-porous, chemical-resistant, and non-shedding — designed to meet ISO 14644 and EU GMP Annex 1 pharmaceutical cleanroom classification requirements.
Grade A (ISO 5): critical aseptic zone, unidirectional airflow. Grade B (ISO 5/7): background for Grade A. Grade C (ISO 7/8): less critical preparation steps. Grade D (ISO 8): general support areas. Each grade has defined airborne particle counts and microbial limits per EU GMP Annex 1.
ISO 14644-1 classifies cleanrooms by airborne particle concentration. ISO 5 equates to GMP Grade A/B at rest; ISO 7 to Grade B in-operation and Grade C at rest; ISO 8 to Grade D. Pharmaceutical cleanrooms must satisfy both ISO 14644 and EU GMP Annex 1 simultaneously.
Essential GMP cleanroom equipment includes HEPA-filtered HVAC systems, laminar airflow units for Grade A zones, pass-through boxes, air showers, pressure differential gauges, continuous environmental monitoring systems, SS316L cleanroom furniture, gowning equipment — all formally qualified through IQ/OQ/PQ before first pharmaceutical manufacturing use.
Cleanroom validation follows DQ → IQ → OQ → PQ. OQ tests HEPA filter integrity, air change rates, airflow velocity, pressure differentials, and temperature/humidity uniformity. PQ confirms ISO/GMP classification limits under operational conditions — including particle counts and microbial monitoring results at rest and in operation.
PUF/PIR provides excellent thermal insulation at low weight — standard for most pharmaceutical cleanrooms. Honeycomb core gives high structural rigidity for partition walls. High-density mineral wool delivers superior fire resistance (EI60 rating) and acoustic insulation — preferred for sterile manufacturing facilities with strict fire safety requirements.
GMP panels use epoxy or PVC coatings resistant to VHP, peracetic acid, sodium hypochlorite, and IPA — without flaking, cracking, or absorbing residues. Joints are sealed with chemically resistant, non-porous epoxy fillers to eliminate crevices where microorganisms and contaminant residues could accumulate between cleaning cycles.
Suppliers should hold fire rating certifications (EN 13501, UL), CE marking, and ISO 14644 compliance experience. They must provide material test certificates (MTCs), surface roughness data, and DQ/IQ documentation support. For sterile manufacturing facilities, familiarity with revised EU GMP Annex 1 (2022) contamination control strategy requirements is essential.
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