& 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.
Qualification and Certification Support
A successful environmental monitoring program begins with the appropriate qualification and certification activities that will lay the groundwork for routine testing. Our team is well-versed in the current industry and regulatory standards and can assist with the following qualification and certification activities:
Cleanroom Qualification Activities
As Built Performance Qualification
At Rest (Static) Performance Qualification
Operational (Dynamic) Performance Qualification
Cleanroom Certification per ISO 14644-1:2015
Utilities Qualification Activities
EM Sample Collection and Analysis
Proactively Identify Trends
Evaluate the Effectiveness of Cleaning and Personnel Practices
Utilities Sample Collection and Analysis
Cleanrooms are commonly equipped with utility systems such as water and compressed air or gasses. It is imperative that these utilities meet the prescribed specifications to ensure that the manufacturing process is not compromised. Our trained analysts are able to perform testing on compressed air and gas systems on-site as well as collect water samples for analysis at our state-of-the-art laboratory facility.
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. A robust environmental monitoring program must address the need for microbial identifications. It is not sufficient to merely quantify organism recoveries as that does not provide insight into the types of organisms and whether or not they can have a negative impact on the product.
Consulting ServicesCleanrooms come in all shapes and sizes. We are here to help your cleanroom achieve a state of control and can provide consulting support to address:
- 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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