WHO-GMP Cleanroom.6 Doorways. Audit-Ready.
A WHO-GMP certified pharmaceutical formulations unit in Baddi, Solan (HP) needed cleanroom-grade doorway separation for its tablet compression and packaging zones — ahead of a scheduled CDSCO audit. Chronovex supplied and installed 200mm × 2mm transparent PVC strip curtains at 6 critical doorways within 9 working days, fully compliant with WHO TRS 961 Annex 2.
When the CDSCO audit is 21 days away
A formulations contract manufacturer in Baddi pharma cluster needed urgent doorway separation between Grade D and Grade C zones to clear an upcoming CDSCO inspection on Schedule M compliance.
21 days to CDSCO audit, 6 doorways without proper separation
The plant's QA head, Dr. Sharma, had received a pre-audit observation from the consultant: 6 doorways between Grade D (general manufacturing) and Grade C (tablet compression) zones had no physical separation. Risk: a formal Schedule M observation could delay product approvals by 60-90 days.
We mapped airflow, not just doorways
Our pharma vertical lead, Anita Singh (B.Pharm + 9 yrs cleanroom), spent a full shift mapping airflow at each doorway with a smoke pencil and digital anemometer. 4 doorways had reverse pressure during forklift movement — a direct cross-contamination risk under WHO TRS 961 Annex 2.
200mm × 2mm flexible transparent PVC strip curtain with 67% overlap
We specified pharma-grade Chronovex PVC strip — 200mm wide, 2mm thick, transparent (visual continuity for forklift operators), with double-fold 67% overlap design. Mounting via SS-304 universal hooks. All strip joints heat-welded for crevice-free GMP compliance.
CDSCO audit cleared with zero strip-curtain observations
21 days later, the CDSCO inspector examined all 6 doorways. Particulate count at the Grade C side stayed within ISO 8 limits during full forklift operation. Zero observations on the strip-curtain installation. The audit closed in 2 days with no major observations on facility design.
Exactly what was installed
Full bill-of-materials with HSN codes, GST-billed and warranty-tracked.
Anita's team understood Schedule M better than our consultant. They redesigned the overlap at our packing zone doorway and the CDSCO inspector specifically complimented that doorway in his closing remarks.
Frequently asked questions
Direct answers from our project engineers.
Is your PVC strip cleanroom-grade?+
How often does the strip need replacement?+
Do you supply for ISO 7 / Grade B zones?+
Is the install dust-free?+
Pharma audit in the next 30 days?
Our pharma vertical can fast-track survey + supply + install within 9-14 working days for projects in Baddi, Vapi, Hyderabad, Goa and Sikkim industrial belts.
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