Clean rooms & equipment of certain ISO classifications are established, maintained & operated for process, product & operators’ safety. These are relevant to specific process applications so that compliance with their intended performances are validated & Thermolab Testing does exactly that under performance qualification & periodic validation through conducting following tests.
Air Flow Pattern Test
Air Velocity Test
Particle Count Test
- Air Velocity Test
- HEPA Filter System Leak Test
- Particle Count Test
- Recovery Test for Particle Count
- Flow Pattern Test etc
Thermolab testing’s scope of services in this stream has been designed to obtain reliable results traceable to National / International Standards.
Services offered by Thermolab Testing:
Thermolab Testing comprehensively tests & validates clean rooms & equipment during qualification & periodic re-validation & ensure compliance with the requirements of applicable standards like ISO 14644 & EN 12469 etc. & the specific process application.
Thermolab Testing performs Clean Room & Equipment Testing for a wide range of equipment & rooms mentioned here under;
Equipments
- Vertical & Horizontal Laminar Air Flow Unit
Microbiological Safety Cabinet - Isolator
- Dynamic Pass Box etc.
Rooms
Classified area from ISO Class 5 to ISO Class 8 as per the requirement of pharmaceutical industries.
Validation Standards:
| Sr. No | Name of Standard | Equipment Range | Accuracy | Traceability |
| 1 | Wireless Data Loggers | -30 to 70°C & 0 to 100%RH | ± 0.5°C & ± 2%RH | National |
| 2 | Wired Data Loggers (21 CFR Part 11 Compliant) | Universal ± 0.3mV & ± 0.02mA | & better than ± 1°C & ± 2°C for T & K Type T/Cs & ± 0.5°C for RTDs | National |
| 3 | Temperature & RH Transmitter | 0 to 50°C & 0 to 100%RH | ± 0.5°C & ± 2%RH | National |
| 4 | Wired Data loggers Thermocouple | All Types | ± 1°C | National |
| 5 | Thermocouple Sensors “T‟ Type Thermocouples | -100 to 400°C | ± 0.5% | National |
