Environmental Monitoring & Cleanroom Services

Environmental monitoring is critical in today's pharmaceutical industry to ensure products are being produced in safe manufacturing and testing environments in accordance with international standards and guidelines to help prevent the release of potentially contaminated products. Alcami can provide support specifically tailored to the needs of your cleanroom. 

Solid principle of our GMP operation starts with a team of qualified and experienced scientists. All environmental monitoring analysts have completed a rigorous training program guided by a comprehensive curriculum that covers sampling and testing standard operating procedures, cleanroom behaviors, proper equipment utilization, and good documentation practices following the ALCOA principles.

Environmental Monitoring Capabilities

Qualification and Certification Support

Baseline studies, cleanroom qualification activities, cleanroom certification per ISO 14644-1:2015, and utilities qualification activities.

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EM Sample Collection and Analysis

Mitigate risk, proactively identify trends, and evaluate the effectiveness of learning and personnel practices.

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Utilities Sample Collection and Analysis

Testing is performed on compressed air and gas systems on-site as well as collect water samples for analysis at our state-of-the-art laboratory facility.

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Microbiology Support

Samples that are collected utilizing our on-site sample collection services or received via mail for incubation are processed at our laboratory facility located in Morrisville, NC.

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Consulting Services

Training (gowning, sample collection, etc), commissioning (cleanroom design, validation, qualification, and certification), protocols and risk assessments, and trending data analysis.

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Real-time electronic documentation from sample preparation through review with immediate notification of excursions.

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Connect with us today to get started with your environmental monitoring needs.