Cleanroom and Pharmaceutical Testing
ISO 9001, NEBB and CETA/CNBT Quality Certified
Cleanroom certifications of new controlled environments and monitoring of existing cleanrooms is an important quality process for organizations doing research. As an ISO 9001 company, GL Technologies has become one of the industry's leading providers of cleanroom testing and certifications for the biopharmaceutical industry. Our team provides vital testing of the cleanroom to make sure there are no contaminants that could cause defects in the product research and data. We offer cleanroom certification to ISO 14644 and formal facility qualification (IQOQPQ) services, an extensive list of equipment qualification IQ/OQs, and compressed gas contaminant testing.
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Cleanroom Certification
Cleanroom certification is not only a requirement to maintain compliance for regulatory agencies, but also to provide reassurance that the cleanroom is free of contaminants and bacteria so it will provide accurate and reliable results during research processes. GL Technologies will provide rigorous testing and assessments to verify the air cleanliness, particle count, temperature, and humidity meet the required standards for sensitve operations. The certification process involves a comprehensive inspection, documentation review, and overall performance evaluation with the goal of making certain that the cleanroom facilities are not only reliable, but meet compliance requirements.
Equipment Qualification
Equipment qualifications are performed on water systems, compressed air and gas systems, HVAC systems, autoclaves, stability chambers, incubators, refrigerators, freezers, ovens and other equipment that has specific user requirements. We can assist with anything from purchasing the appropriate equipment to use of equipment to protocol development.
What Is Lab Equipment Calibration?
Equipment calibration for a laboratory is the practice of adjusting measuring tools to ensure that they meet an accepted standard. Once calibrated, your equipment should provide consistent, accurate, repeatable results that will adhere to review and audit requirements, thus safeguarding the integrity of your facility’s work.
Calibration is carried out by comparing a tool’s measurements against a benchmark measurement and adjusting the apparatus as necessary. This type of assessment is crucial for any piece of equipment that measures, including dimensional measurements, scales, thermometers, spectrophotometers and more.
How Often Should Lab Equipment Be Calibrated?
Calibration requirements vary by type of equipment, application and usage, among other factors. In general, manufacturers' documentation can provide a baseline recommendation for calibration, which may be anywhere from yearly to monthly. In addition, be sure to calibrate lab tools prior to any critical processes, any time data is in question and after any abnormal incident with an apparatus (such as accidents or mishandling).
To request more information or a quote, please fill out our onlineRequest Informationform or call!
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