Independent classification testing and ongoing performance monitoring for cleanrooms and controlled environments. We work to ISO 14644-1 and -2, preparing bespoke monitoring plans and producing clear compliance reports accepted by regulatory authorities in pharmaceutical, medical device, aerospace and life science sectors.
Cleanroom classification and ongoing monitoring are regulatory requirements in pharmaceutical and medical device manufacturing, and operational necessities in aerospace, electronics and life science settings. ISO 14644-1 specifies the statistical methodology for classifying cleanrooms by airborne particulate cleanliness; ISO 14644-2 defines the monitoring programme required to maintain that classification between requalification events. Viridian Air provides independent third-party monitoring services, ensuring that classification testing and monitoring programmes are free from the bias inherent in self-certification. Our instrumentation is maintained in calibration with traceable certification, and our reports are written to satisfy both internal quality systems and external regulatory inspection.
EU GMP Annex 1 (2022 revision). The revised EU GMP Annex 1, effective September 2023, significantly strengthens requirements for environmental monitoring in sterile manufacturing. If your facility manufactures sterile medicinal products for the EU market, your monitoring programme may need updating to reflect the new requirements. We can carry out a gap analysis against the revised Annex 1.
We review your facility layout, classification targets and operational requirements to prepare a statistically valid sampling plan compliant with ISO 14644-1 Annex B. The number and location of sampling points, sample volume and number of sequential runs are specified in advance and documented.
Airborne particle counts are measured using calibrated optical particle counters at all designated sample locations. Results are processed using the ISO 14644-1 statistical methodology to determine the achieved ISO class at 0.5 μm and 5.0 μm particle sizes.
For ISO 14644-2 compliance, we prepare a site-specific monitoring programme specifying monitoring locations, sampling frequencies, particle size channels, alert limits and action limits. The programme is designed to detect deterioration in cleanroom performance at the earliest opportunity.
We issue a detailed classification report documenting all raw data, statistical calculations, instrument calibration certificates, and the achieved ISO class for each zone. The report is formatted to satisfy quality management system requirements and regulatory inspection.
HSE WEL compliance monitoring for dust, gases and VOCs in industrial and commercial workplaces.
Planning application assessments for pharmaceutical and life science facility development.
Construction and operational air quality mitigation for new facility builds.
Tell us about your scheme and we will confirm requirements and provide a fixed-fee quotation within 24 hours.
Specialist air quality consultants for planning applications and workplace compliance across the UK. From initial scoping to submission-ready reports, we work closely with clients and local authorities to ensure a fast, smooth approval process.
