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Cleanroom Certifications/Validations

For more than 40 years, the Federal Standard 209 was one of the most important guidance documents in the cleanroom technology industry. However, in 2001 in an effort to unify global cleanroom standards, the federal government made a move to officially replace this document with the current gold standard, ISO 14644 Cleanrooms and Associated Controlled Environments. This document outlines the basic requirements for cleanroom operations and provides general details on the methods and programs for routine monitoring of controlled environments.

As a Cleanroom Performance Testing Contractor, Sure-BioChem Laboratories is dedicated to ensuring successful certification outcomes. Our certification team has experience qualifying cleanrooms of all classes and applications. Whether scientific or industrial or ISO 3 to ISO 9, Sure-BioChem Laboratories'
expertise in a wide variety of cleanroom applications makes us a preferred source for competent cleanroom certification in accordance to ISO 14644-1 and 2 specifications.

SBL's cleanroom services include the following:

  • Testing and certification of all classifications of ISO cleanrooms and anterooms including particle counting, HEPA filter integrity testing, airflow volume/velocity, room pressurization, temperature and humidity monitoring.
  • Environmental monitoring of air and surface microbes including the development of sampling plans, sample collection, incubation, analysis, microbial identification, reporting and data trending.
  • Compressed air testing for non-viable and viable particles, hydrocarbons and dew point.
  • Competency training, both initials and continued education, for cleanroom best practices, aseptic technique, deviations and gowning.
  • Consultation on contamination investigations and quality system documentation.
Germs

Routine Environmental Monitoring:

Sure-BioChem Laboratories also offers ongoing monitoring support to help clients maintain environmental control of their facilities. Support includes:

  • Non-Viable Airborne Particles

  • Airborne Viable Organisms and Identifications

  • Surface Viable Organisms and Identifications

  • Room Pressure

  • Room Temperature/Relative Humidity

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