Analytical Centre for Validation (Certification) and Measuring
Analytical Centre for Validation (Certification) and Measuring is a structural division of the plant and is accredited for the technical compliance and independence by the State Committee of the Russian Federation for standardization and Metrology (Gosstandard of Russia). Certificate № РОСС RU.0001.513956.
The Centre specializes in validation of cleanrooms for health-care institutions, pharmaceutical electronic and microbiological manufacturing companies.
Its activities include:
- Stage DQ: qualifying of contract documents for cleanrooms and air cleaning systems as conforming with the requirements quoted in normative documents
- Stage IQ: qualifying of assembly works – evaluation and supporting documents for cleanrooms assembly and air cleaning systems as conforming with the requirements quoted in technical and contract documents;
- Stage OQ: qualifying of operation – supporting documents for cleanroom systems operability as conforming with the requirements quoted in normative and technical documents, furthermore, measuring of cleanroom air rates and working environment parameters.
On completing all the qualifying procedures the Centre provides the test result logs and validation (certification) reports.
The Centre is equipped with appropriate measuring equipment employs highly qualified specialists having a wide potential of experience in validation (certification) at pharmaceutical and electronic manufacturing companies.
Validation (certification) process are agreed while negotiating and depend on area quantity and purity class of cleanrooms.
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