GMP Dry Coil Compliance Checklist

Self-check the items procurement and QA teams typically verify before approving a pharmaceutical dry cooling coil for a GMP process area. Check off what you already have confirmed.

0 / 10 confirmed

Design & Standards

Cleanroom grade (A/B/C/D) and target RH/temperature band confirmedFeeds directly into the DCC unit count and precision spec Design aligned to EU GMP Annex 1 (2022) grade and pressure-cascade requirements§4.4 grade definitions, §4.16 minimum 10 Pa differential ISO 14644-1 classification (particle limits, static/dynamic) documented

Materials & Construction

Wetted-material grade specified (e.g. SS316L / SS304 / copper) with mill certificates Sanitary construction criteria confirmed against EHEDG / 3-A / ASME BPE where applicable

Testing & Traceability

Factory pressure test result on file (≥0.6 MPa hold, drop within spec) Component-level material traceability chain available (mill cert → serial number) Supplier utilities-qualification documentation ready for audit (a named FDA 483 checklist category)