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Sterility testing. Sterility can be defined as the freedom from the presence of viable microorganisms. However, the conditions that guarantee absolute sterility are usually too harsh for active ingredients, and the definition of sterility for a medicinal product must be defined in functional terms.
Guidance is provided on the documentation expected for sterile finished products, sterile active substances, sterile excipients and sterile primary containers (referred to as container in this guideline)
This enables you to take samples whenever needed or to transfer samples into a rapid detection system after only a few days of incubation. A secure and flexible method no one else can offer you. Shop Sterility Testing Products. Download Sterility Testing Playbook.
Detect bacterial and fungal contamination within 3 hours using the proven real-time PCR method in our Microsart ® ATMP Sterile Release Kit, a combination of Microsart ® ATMP Bacteria and of Microsart ® ATMP Fungi.
sterilization (non-sterile products). The purpose of sterilization is to inactivate the microbiological contaminants to transform the devices from non-sterilized to sterilized. Sterility testing of medical devices is required during the sterilization validation process and routine release testing. According to ISO 11737-2
9 Αυγ 2021 · Introduction. Sterility assurance for the healthcare industry spans many sectors: medical devices, pharmaceuticals, biopharmaceuticals, sterile barrier packaging systems, biologics/tissues, and healthcare facilities.
A sterile medical device is one that is free from viable microorganisms. International Standards that specify requirements for validation and routine control of sterilization processes require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device from all sources be minimized.
