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.Learn More
EM Sample Collection and Analysis
Mitigate risk, proactively identify trends, and evaluate the effectiveness of learning and personnel practices.Learn more
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.Learn more
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.Learn more
Training (gowning, sample collection, etc), commissioning (cleanroom design, validation, qualification, and certification), protocols and risk assessments, and trending data analysis.Learn more
Real-time electronic documentation from sample preparation through review with immediate notification of excursions.Learn more