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The guideline concerns specific requirements related to sterility, sterilisation processes and aseptic processing of sterile products and product components.
1. General considerations. 1.1 The production of sterile preparations should be carried out in clean areas, entry to which should be through airlocks for personnel and/or for equipment and materials.
Guidance is provided on the documentation expected for sterile finished products, sterile active substances, sterile excipients and sterile primary containers in a new marketing authorisation application or a variation application for a medicinal product.
28 Νοε 2023 · Overview. The delivery of sterile products for use in patient care depends not only on the effectiveness of the sterilization process but also on the unit design, decontamination, disassembling and packaging of the device, loading the sterilizer, monitoring, sterilant quality and quantity, and the appropriateness of the cycle for the load ...
1 Ιαν 2018 · This chapter provides a comprehensive overview on the concept of sterilization, including the factors affecting sterilization, risk assessment, sterility testing protocols, incubation, examination, and validation of sterility tests.
With sterilisation, and returning to the theme of sterility as a probabilistic idea, this chapter examines the Sterility Assurance Level (SAL) in relation to terminal sterilisation and contrasts this quantitative assessment with aseptic processing, which is reliant upon environmental controls.
8 Οκτ 2024 · The process of ensuring the safety of products labeled as sterile is referred to as sterility assurance (as outlined in USP chapter <1211>). This concept underscores the importance of a systematic approach to sterility that prioritizes robust process controls over reliance on testing alone.
