Environmental Monitoring & Cleanroom Services
Alcami Environmental Monitoring and Cleanroom Services Team provides external sampling, testing, and consultation specifically tailored to your cleanroom and critical utilities. Our Environmental Monitoring and Cleanroom Services team has completed a rigorous training program guided by a comprehensive curriculum that covers sampling, testing, proper cleanroom behaviors, and good documentation practices following the ALCOA principles based on our own audited and inspected policies and standard operating procedures.
Environmental Monitoring is an essential component to your sterility assurance program. Our comprehensive pharmaceutical support services are designed to help our clients get the most out of their laboratory and manufacturing spaces.
Qualification & Certification Support
- Baseline environmental assessments
- Room recovery studies
- Static and dynamic performance qualification
- Cleanroom Certification per ISO 14644-1; 2015
EM Sample Collection and Analysis
Onsite Sample Collection (viable surface monitoring, viable and non-viable particulates, etc.)
Real-time documentation from collection through report via MODA-EM®
Utilities Sample Collection and Analysis
- Water systems (feed water, RO/DI, USP water, WFI, clean steam, etc.)
- Compressed gas systems (oxygen, nitrogen, carbon dioxide, etc.)
- Pharmaceutical compressed air
- Incubation and enumeration
- Microbial identification (MicroSEQ®)
- Disinfectant efficacy studies
- Biological indicator population verification and post-exposure evaluation
- Training (gowning, cleanroom behavior, sample collection, etc.)
- Process flow and design
- Protocol generation
- Risk assessments
- Trending (data analysis)
- Real-time electronic documentation from sample preparation through review
- Immediate notification of excursions
- Email notifications for the collection, incubation, and enumeration of samples
- Continuous trending with visuals including heat maps
We deliver unmatched expertise and timely customer service.
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