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Pharmaceutical & Healthcare — EU GDP Cold Storage
GDP-compliant cold storage for pharmaceuticals, vaccines and biologics. ±0.5°C temperature uniformity. 21 CFR Part 11 data logging. IQ/OQ/PQ validation packages.
EU GDP±0.5°C21 CFR Part 11IQ/OQ/PQGMP Grade A–D
±0.5°C
Uniformity
21 CFR
Part 11
IQ/OQ/PQ
Validation
GDP
EU Compliant
GDP Cold Storage Specifications
| Temperature Range | +2°C to +8°C (±0.5°C uniformity) |
| Panel | 100mm PIR · λ=0.022 W/mK · AISI 304 facing |
| Data Logging | 21 CFR Part 11 compliant SCADA / BMS |
| Alarms | Multi-point temp · door ajar · power fail · freeze protect |
| Temp Mapping | Initial + periodic per EU GDP guidelines |
| Access Control | Card/PIN entry · audit trail · CCTV |
| Validation | IQ/OQ/PQ docs · SOP templates · deviation reports |
| HVAC | HEPA-filtered AHU · positive/negative pressure |
| Standards | EU GDP 2013/C 343/01 · WHO TRS 961 · PIC/S PE 011 |
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Our engineers respond within 24 hours. Upload drawings or BOQ for fast-track review. EXW to DDP worldwide — Pharmaceutical Cold Storage.
+90 262 657 40 40 · info@arcopan.com.tr · CE · ISO 9001:2015 · HACCP