Clean Room Validation Company

Clean rooms must be validated prior to operation.

Clean room validation company.

Clean room ahu manufacturer supplier and exporter services with system pharma area validation and designed in mumbai india. Kes validation specialise in providing independent cleanroom validation services for the pharmaceutical medical devices semi conductor and healthcare industries. The normal wind stream speeds are figured by isolating the aggregate of the air flow grille speed by the quantity of readings given. It serves to ensure that the cleanroom is properly installed and designed for its intended iso classification and that all of the components facility environment equipment meet regulatory requirements and other defined standards.

The criteria that must be measured in order to validate a clean room include. It includes numerous different tests that must be performed in various cleanroom states in order to verify that the cleanroom is fit for its intended use and meets the stipulations set forth for the classification requirements governing the cleanroom application. The volume and quality of air supplied air movement between the clean room and other rooms air movement within the clean room and the particle counts in the clean room including microbiological if. Our in house teams can develop and execute site specific iq oq documentation in line with facility and client requirements and perform hands on clean room qualification in line.

Cleanroom validation is more than simply counting particles. Autocal performs the hvac validations as per iso 14644 1 2 3 eu gmp ec gmp who trs 937 who trs 961 schedule m national regulatory body guidelines for all room classifications. Validation is an important process for any cleanroom. We provide and extensive range of services pertaining to clean room validation by our panel of expert professionals available with us.

Most often cleanrooms are validated by third party validation.