Comprehensive Overview

Pharmaceutical manufacturing plants, food packing halls, hospital operation theaters, and semiconductor cleanrooms require periodic environmental monitoring to maintain ISO Class 5 to Class 8 air cleanliness. We perform active air sampling, settle plate exposure, surface swab sampling, and airborne laser particle counting.

Applicable Regulatory Standards & Testing Protocols

✓ ISO 14644-1 (Cleanrooms and Associated Controlled Environments) ✓ EU GMP Annex 1 (Manufacture of Sterile Medicinal Products) ✓ IS 13770 Cleanroom Guidelines

Analyzed Parameters & Test Methods

Airborne Particle Concentration (0.5 µm and 5.0 µm particles/m³)

Active Airborne Viable Microorganisms (CFU/m³ using Air Sampler)

Passive Settle Plates (CFU/4 Hours exposure)

Surface Microbial Contamination (Swab / Contact Plate CFU/25 cm²)

Personnel Glove / Gown Contact Sampling (CFU/Glove)

ISO Class 5, 6, 7, 8 Air Cleanliness Classification

Sample Intake & Turnaround Protocol

On-Site Cleanroom Grid Sampling & Swab Collection | Turnaround Time: 3 - 5 Working Days

Key Scope & Execution Deliverables

Calibrated Laser Airborne Particle Counter with 28.3 L/min flow rate

Slit-to-Agar / Impactor Air Sampler for viable microbe capture

Cleanroom qualification report (IQ/OQ/PQ support documentation)

Settle plate and contact plate incubation at 20-25°C and 30-35°C

Key Business & Regulatory Benefits

Maintains WHO-GMP cleanroom compliance for pharmaceutical facilities

Prevents airborne microbial contamination during sterile product filling

Required Document Checklist

Cleanroom Floor Layout & Target ISO Class (Class 100, 10,000, 100,000)
HVAC Air Change & Pressure Differential Log