New cleanroom builds
Greenfield or expansion projects needing classification targets, URS, and qualification protocols.
- URS
- Design
- Classification
Industry · Cleanroom & Validation
Cleanroom qualification and validation
Device, pharma, and healthcare sites use NQSC for ISO 14644 classification, HVAC qualification (IQ/OQ/PQ), monitoring plans, and validation reports that support licensing and GMP dossiers.
- 25+Years Experience
- 500+Companies
- ISO 14644
- IQ · OQ · PQ
Cleanroom & Validation
ISO 14644 · Process Validation
ISO 14644 classification, HVAC qualification, monitoring, and validation reporting for device, pharma, and healthcare controlled environments.
Who we help
Teams in this sector
Share your site type and regulatory goal. NQSC maps support to published service pages.
Pharma sterile and non-sterile areas
Controlled rooms supporting WHO-GMP or Schedule M inspections with airflow and pressure evidence.
- GMP
- HVAC
- Pressure cascade
Medical device assembly
Assembly or packaging areas where ISO 14644 records support CDSCO or ISO 13485 audits.
- Assembly
- Packaging
- Monitoring
Requalification programmes
Sites planning periodic requalification, filter changes, or layout modifications.
- Requalification
- Change control
- Reports
Regulatory context
ISO 14644 and GMP expectations
Cleanrooms for regulated products are qualified against ISO 14644 parts for classification and monitoring. GMP guides expect controlled environments to be validated and maintained.
ISO 14644-1 defines airborne particle classification for cleanrooms and controlled environments.
Source: ISO 14644
ISO 14644-2 covers monitoring to demonstrate continued compliance with the chosen class.
Source: ISO 14644-2
WHO and national GMP texts expect qualification, requalification, and deviation management for HVAC and classified areas.
Source: WHO GMP
NQSC services
Services for cleanrooms and validation
Cleanroom validation, WHO-GMP, and audit support for controlled environments.
Typical pathway
How teams usually progress
A structured view from scope confirmation through maintenance.
Classification target
Agree ISO class, occupancy state, and room use with process and quality teams.
Protocol design
Draft IQ/OQ/PQ or classification protocols aligned to room drawings and HVAC design.
Execution support
Coordinate testing with qualified laboratories; NQSC supports protocols and reports.
Monitoring plan
Define ongoing particle, pressure, and maintenance monitoring after qualification.
Dossier linkage
Place summary reports in SMF, device, or GMP submission packs as required.
Avoid delays
Common mistakes in this sector
Issues NQSC often sees during readiness reviews before filing or audit.
Testing at rest only
Operational particle counts differ from at-rest results; both states must be planned where required.
Missing pressure cascade evidence
Cross-contamination risk increases when differential pressure data is incomplete.
No requalification schedule
Filters, layout changes, or shutdowns require documented requalification triggers.
Reports not linked to submissions
Licensing or GMP files fail when validation summaries are absent from the master dossier.
FAQ
Cleanroom and validation questions
Short answers on forms, timelines, restrictions, and how NQSC supports your pathway.
Accredited laboratories perform tests. NQSC prepares protocols, coordinates execution, and drafts qualification reports.
Open the Cleanroom Validation Consultant page for documents, process steps, and FAQs.
Yes. Protocols differ by product type and class; share your room use and GMP or device context.
Pharma sites often need both. The WHO-GMP service page covers GMP records; cleanroom pages cover ISO 14644 qualification.
Plan cleanroom qualification
Tell us room type, target ISO class, and linked GMP or device submissions.