Cleanroom Sandwich Panel Compliance: GMP, ISO 14644, Fire Ratings & Documentation Requirements
? 1. GMP Compliance for Pharmaceutical Facilities
What GMP Requires from a Cleanroom Sandwich Panel:
Requirement | Specification |
|---|---|
Surface smoothness | Ra ≤ 0.8µm — no ledges, crevices, or pores |
Cleanability | Must withstand repeated cleaning with disinfectants |
Material resistance | Must resist VHP, bleach, and peracetic acid |
Joint design | Cleanroom sandwich panel with flush joint — no ledges |
Documentation | Mill certs, fire test certificates, coating reports |
GMP-Ready Panel Specification:
Core: Cleanroom sandwich panel with rockwool core (≥120 kg/m³)
Skin: Cleanroom sandwich panel with stainless steel or cleanroom sandwich panel with antimicrobial coating
Joint: Cleanroom sandwich panel with flush joint
Corners: R30 or R50 radius profiles
? 2. ISO 14644 Cleanroom Classification
How ISO 14644 Affects Panel Selection:
ISO Class | Particle Limit (≥0.5µm) | Typical Application | Panel Recommendation |
|---|---|---|---|
ISO 5 | 3,520/m³ | Pharmaceutical filling | Cleanroom sandwich panel with stainless steel + flush joint |
ISO 6 | 35,200/m³ | Pharmaceutical secondary | Cleanroom sandwich panel with antimicrobial coating + flush joint |
ISO 7 | 352,000/m³ | Electronics assembly | Cleanroom sandwich panel with rockwool core + flush joint |
ISO 8 | 3,520,000/m³ | General manufacturing | Cleanroom sandwich panel with rockwool core + standard joint |
Key ISO 14644 Requirements:
Air tightness: Panel system must maintain pressure differential
Surface cleanability: No particle shedding from walls or ceilings
Material durability: Panels must not degrade and release particles over time
? 3. Fire Ratings: What You Need to Know
Core Fire Rating Comparison:
Core Type | Fire Rating | Standard |
|---|---|---|
Rockwool | A-grade (non-combustible) | EN 13501-1 A2, GB 8624 A |
MgO | A-grade (fire-resistant up to 1200°C) | EN 13501-1 A1 |
PIR | B1 (flame-retardant) | EN 13501-1 B-s1, d0 |
Aluminum Honeycomb | A-grade (non-combustible) | EN 13501-1 A2 |
EPS | B2 (flammable) — NOT for cleanrooms | — |
Fire Test Certificates You Must Request:
EN 13501-1 (European standard)
GB 8624 (Chinese standard)
ASTM E84 (US standard, if applicable)
? 4. Documentation Requirements for Audits
Essential Documents:
Document | Purpose |
|---|---|
Mill certs | Traceability of steel coils used in skins |
Fire test certificate | Proof of fire rating |
Coating thickness report | Proof of coating quality |
Core density report | Proof of core quality |
Installation records | Proof of correct installation |
Pressure decay test results | Proof of air tightness |
Smoke test photos/video | Visual proof of joint sealing |
Where to Keep Documents:
On-site in a compliance binder
Digital copies in a cloud system
With the cleanroom sandwich panel supplier for reference
? 5. SAMZOON: Compliance-Ready Panels
As a cleanroom sandwich panel Foshan manufacturer, SAMZOON provides:
Full documentation — mill certs, fire test certificates, coating reports
GMP-ready specifications — cleanroom sandwich panel with stainless steel skin, cleanroom sandwich panel with antimicrobial coating, cleanroom sandwich panel with flush joint
Fire-rated cores — cleanroom sandwich panel with rockwool core, cleanroom sandwich panel with magnesium oxide core, cleanroom sandwich panel with aluminum honeycomb core
Cold room solutions — cleanroom sandwich panel with PIR core
Installation support — a cleanroom sandwich panel installation guide with every order
✅ 6. Compliance Checklist
Item | Status |
|---|---|
GMP surface finish (Ra ≤ 0.8µm) | ☐ Verified |
Flush joint system | ☐ Installed |
Fire test certificate | ☐ On file |
Mill certs | ☐ On file |
Coating thickness report | ☐ On file |
Pressure decay test passed | ☐ Completed |
Smoke test passed | ☐ Completed |
Installation guide on site | ☐ Available |
