Physical and microbiological testing in controlled environments

With its consolidated experience, LabAnalysis performs services and controls (validation of HVAC systems, control of clean rooms and sterile environments, cell factories, operating theatres, both with field measurements and with the drafting of control and validation protocols) in compliance with ISO 14644-1, ISO 14644-2, ISO 14644-3 standards updated to the latest versions in force, EU GMP Directive, Annex 1 - "Manifacture of sterile Medicinal products".

Labanalysis has a team of more than 10 qualified technicians (graduates in Physics, Engineering and Biology), some of whom are qualified by ICEB (International Cleanroom Education Board) as technicians for investigations and tests in controlled contamination environments; it also has all the instrumentation needed to carry out chemical, physical and microbiological controls.

The sector offers the following services: 

• Validation of HVAC systems and classification of controlled atmosphere environments according to ISO 14644-1 and EU GMP using electronic particle counters
•  Audits planned to demonstrate continuous compliance according to ISO 14644-1, ISO14644-2, ISO 14644-3, EU GMP Directive - Annex 1 where applicable
• Periodic upgrading checks for cleanroom systems - cleanrooms - hoods - isolators
• Verification of air speed, calculation of flow rate and number of changes per hour
• Verification of differential pressures in controlled environment rooms
• Verification of temperature in controlled environment rooms
• Verification of relative humidity in controlled environment rooms
• Verification of recovery time 
• Effective changes
• Verification of particle contamination class
• Verification of tightness, integrity and pressure drop of absolute filters in controlled environment rooms
• Verification of microbiological contamination (measurement using surface plates, swabs, air sampling using SAS sampler, sedimentation plates) 
• Consulting in drafting control protocols and process validation for sterile environments
• Checks and controls on operating theatres according to ISPESL "Guidelines on safety and hygiene standards in the operating theatre".
• Particle contamination
• Microbiological contamination of surfaces and air (both in At-Rest and Operational conditions)
• Microclimate characteristics
• Pressure gradients
• Air exchanges
• Volumes of injected air
• Recovery Time (i.e. recovery performance after an event that generated airborne particles)
• Quality of water (standard and technical) delivered        
• Degree of illuminance
• Noise.

In particular, it has the following appropriately calibrated instrumentation:

• 4 laser particle counters
• 1 smoke generator
• 1 DOP generator
• 1 photometer
• 1 low-pressure calibrator
• Anemometers
• 1 Balometer
• Hot-wire anemometers
• Temperature and humidity meters
• 4 Microbiological samplers (SAS)