Validation

Why validation?

-To ensure that the design of the facility equipment, and environment meets User Requirement & is the best fit for its intended purpose.

- Cleanroom validation is provided by conducting a series of tests to qualify if a controlled environment is performing in accordance with process requirements and the applicable regulatory guidelines, such as ISO 14644-1:2015 or GMP Annex 1.

Purpose of validation ?

To assess the cleanliness status of the clean room what is recommended to overcome the challenge of Dust, Dirt & Infection due to Infiltration & Contamination

  • Validation studies shall be an essential part of Good Manufacturing Practices.
  • and shall be conducted as per the pre-defined protocols. These shall include.
  • validation of processing, testing and cleaning procedures.
Validation parameters
Expert Clean Room Validation in Kolkata
AEROSOL Photometer
Expert Clean Room Validation in Kolkata
AIR CAPACITY MEASUREMENT USEING AIR CAPTURE HOOD
Expert Clean Room Validation in Kolkata
AIRBONE PARTICLE COUNTER
Expert Clean Room Validation in Kolkata
ANEMOMETER
Expert Clean Room Validation in Kolkata
HANDLEND AIRBONE PARTICLE COUNTER
Expert Clean Room Validation in Kolkata
HYGROMETER
Expert Clean Room Validation in Kolkata
LUX METER
Expert Clean Room Validation in Kolkata
DIGITAL SOUND LEVEL METER
Expert Clean Room Validation in Kolkata
SET OF AIRBONE PARTICLE COUNTER
Expert Clean Room Validation in Kolkata
VIBRATION METER
Expert Clean Room Validation in Kolkata
Expert Clean Room Validation in Kolkata

Our Major Clients

STANDARDS TO-BE FOLLOWED :