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Environmental Monitoring
& Cleanroom Services

Environmental monitoring is an essential and critical component of a sterility assurance program that is used to demonstrate the state of control of manufacturing and testing environments. Alcami can provide support specifically tailored to the needs of your cleanroom.

Solid principle of our GMP operation starts with the 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.

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Environmental Monitoring and Cleanroom Services that DELIVER exceptional expertise and timely customer service.

 

Alcami-EM

Qualification and Certification Support

  • Baseline Studies

  • Cleanroom Qualification Activities

  • Cleanroom Certification per ISO 14644-1:2015

  • Utilities Qualification Activities

EM Sample Collection and Analysis

  • Mitigate Risk

  • Proactively Identify Trends

  • Evaluate the Effectiveness of Cleaning and Personnel Practices

Utilities Sample Collection and Analysis

  • Testing 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

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

  • Samples are handled by our microbiologists to ensure that they are placed on test in a timely manner.

  • After incubation, samples are enumerated and recommendations are made regarding microbial identifications

Consulting Services

  • Training (gowning, sample collection, etc.)

  • Commissioning (cleanroom design, validation, qualification, and certification)

  • Protocols and Risk Assessments

  • Trending (data analysis)

MODA-EM™ Paperless QC Micro Solution

  • 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

 

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