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Pharma & GMP Cleanrooms

C/D-grade suites with pressure cascades, airlocks and the validation paperwork your QA team will actually sign.

GMPISO 7 / ISO 8PRESSURE CASCADE

Engineered for validation, not just construction

  • Pressure cascade design: ≥10-15 Pa steps room-to-room, differential gauges at every boundary, smoke-test verified
  • ISO 7 (Class 10K) cores with ISO 8 support areas; airlocks (PAL/MAL) and dynamic pass boxes at every material transfer
  • HVAC per GMP: DX or chilled-water AHUs with H13 terminal filtration, 20-60 air changes/hour by grade
  • Validation pack: DQ drawings, airflow schema, third-party particle/microbial reports, filter certificates — audit-ready at handover
  • Cleanable envelope: flush windows, coved corners, hermetic doors, walkable ceilings on request
Request an Engineering Review
GMP pharmaceutical cleanroom corridor with steel doorsISO 7 / ISO 8
GMP Pharmaceutical Cleanroom equipment
GMP Pharmaceutical Cleanroom equipment
GMP Pharmaceutical Cleanroom equipment

How a pressure cascade protects your product

CORRIDOR 0 Pa GOWNING +5 Pa ISO 8 / GRADE D +10 Pa ISO 7 / GRADE C · CORE +15 Pa AIR ALWAYS LEAKS OUTWARD — PARTICLES NEVER LEAK IN MIN 5 Pa PER STEP (GB 50073) · GAUGES AT EVERY BOUNDARY · SMOKE-TEST VERIFIED
BESTCLEAN ENGINEERING · SHEET GMP-01DESIGNED ROOM-BY-ROOM FOR YOUR SUITE

Grade map & air change reference

GRADEISO CLASSTYPICAL ROOMSAIR CHANGES/H
CISO 7 (10K)Preparation, filling support30–60
DISO 8 (100K)Washing, packaging, corridors20–30
CNC300KWarehouses, technical areas10–15

REFERENCE VALUES — FINAL DESIGN IS ENGINEERED TO YOUR PRODUCT AND AUDIT SCHEME.

Equipment for this industry — from our own line

ISO 7 pharma suite with full pressure cascade — validated first pass

Planning Guide

ISO 7 pharma suite with full pressure cascade — validated first pass

READ GUIDE →
TECHNICAL SCOPE & PROJECT REVIEW

"Send me your floor plan. I'll tell you what it really costs."

Define the technical requirements, responsible reviewers and acceptance records for your project.

Ask the Engineer

Frequently asked questions

Which GMP grade maps to which ISO class?

Grade C ≈ ISO 7 (Class 10,000), Grade D ≈ ISO 8 (Class 100,000). We design pressure cascades and air-change rates per grade and verify with third-party testing at handover.

Do you supply validation documentation?

Yes — DQ drawings, airflow schemas, filter certificates and third-party particle/microbial reports are part of standard handover, formatted for QA review.

Can you match an existing facility's URS?

Send your URS — our engineers return a compliance matrix showing how each requirement is met, exceptions flagged, on an agreed schedule.

Do you build outside China?

Yes — supervision teams for Vietnam, Thailand, Indonesia, Malaysia and the Philippines; equipment-and-drawings packages for other regions.

Planning a gmp pharmaceutical cleanroom?

Send a floor plan, application and target conditions. Confirm the review scope, equipment requirements and quotation schedule.

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