Each project is evaluated from both a technical and statutory perspective to avoid formulaic solutions often utilized in the clean room industry.
USP <797> & <800> Compliance:
Facility Modification or New Construction
Our approach towards compliance is simple and direct. Each project is begun by conducting an onsite assessment of the facility via meetings with keys personnel to determine the types and volumes of product expected to be produced at the facility. Considerations documented at this initial design stage include the future goals of the organization, as well as size, location, and limitations of existing utilities present within the area to be built or upgraded. Placing key personnel into the design review process from the first day, assures good communication and prevents the end user from being “out of the loop” on their own project. Our project quotes are researched and detailed to minimize change orders. Change orders can increase pricing due to a lack of detail during initial reviews.
Validation, Certification and Routine <797> & <800> Monitoring
With over thirty years of experience in the conduct of culturable industrial microbiological environmental testing, and an in-house laboratory, timely and cost-effective routine monitoring is assured. Samples are placed into incubation the same day they are collected, and shipping expense is eliminated. Care is given to ensure that results are useful in managing the contamination control program of the customer, not just becoming a piece of paper that is filled away because of a standards requirement. When out of specifications results are recovered, a review of historical data is utilized to provide guidance on corrective actions needed to document a return to normal operational conditions. This testing is designed to meet the requirements of both USP and CETA for compliance with CBOP.
Procedural Documentation, Training and Consultation
While meeting compliance required by new industry requirements, it is always important to design standards operating procedures, which will provide the required level of control while being practical to the end user and realistic given variables present in the operation. Please feel free to contact us to discuss your needs, no matter how small or large.