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