- Baseline Studies
- 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
Proactively Identify Trends
Evaluate the Effectiveness of Cleaning and Personnel Practices
Not only is Alcami able to provide on-site sample collection; we are also able to incubate and analyze environmental monitoring samples collected by your team.
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.
- Training (gowning, sample collection, etc.)
- Commissioning (cleanroom design, validation, qualification, and certification)
- Protocols and Risk Assessments
- Trending (data analysis)
Our environmental monitoring program is further enhanced by MODA-EM™ software, a Lonza trademark registered in the USA. This paperless quality control solution was chosen for its ability to incorporate one of our core values: data integrity. Additional benefits of MODA-EM™ are:
- 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