Learn Cleanroom Validation

Cleanroom Validation

We need To tell you about cleanroom validation.

Cleanroom inspections are conducted by performing a series of tests to verify that the controlled environment is complying with applicable process requirements and regulatory guidelines, such as ISO 14644-1: 2015 or its annex. The GMP 1 with Cleanroom Standard qualification test schedule will certify the Class of your cleanroom and local air cleaning equipment and then produce a report on time within 24 hours as evidence for cleanroom test takers.

Cleanroom คลีนรูม
Cleanroom
Cleanroom คลีนรูม
มาตรฐาน-Cleanroom-ในอุสหากรรม

Step to Cleanroom Validation

Building your Custom Testing Schedule

Cleanroom Validation Overview

Our team will work with you to assess your needs to create a customized test schedule. In determining the best cleanliness test we will consider such factors as:

  • ISO standard or GMP guideline requirements
  • Validation frequency requirements, including annual and interim testing
  • Your URS, risk assessment and monitoring plan

Cleanroom Validation Type

Tests will depend on whether a cleanroom procedure requires features such as:

  • Installation Qualification (IQ) – meeting user and design requirements
  • Operational Qualification (OQ) – operating within the defined conditions
  • Performance Qualification (PQ) – producing the defined results

Summary Cleanroom Validation

Documents confirming our clean room inspections are detailed and verifiable. You will receive a report on the day of testing, followed by a full report. Reporting is in accordance with ISO standards and GMP guidelines to meet the needs of you and that of nominated regulators such as Biotech, GPO.

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