EUROLAB laboratory provides testing and compliance service within the scope of USP 1116 standard. USP section 1116 Microbiological Control and Monitoring of Aseptic Processing Environments contains a comprehensive description, description, and guidance regarding microbiological control and monitoring in aseptic processing environments.
Section 1116 is arguably one of the USP's most comprehensive informative sections and is particularly challenging due to its recommendation to measure microbial contamination based on Contamination Recovery Rates (CRR) rather than traditional colony forming units (cfu) counting.
It is important to note that section 1116 is a "general information" section and therefore "provides information and recommendations for environments where the risk of microbial contamination is controlled through aseptic handling".
The scope of the section has been narrowed to apply to the following products manufactured in an aseptic processing environment:
EUROLAB assists manufacturers with USP 1116 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
