Sterile Products
Found 4 free book(s)NfG on Maximum shelf-life for sterile products for human use
www.ema.europa.euUNPRESERVED STERILE PRODUCTS General Chemical and physical in-use stability has been demonstrated for x hours/days at y oC. From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.
Annex 6 WHO good manufacturing practices for sterile ...
www.who.intFinishing of sterile products References Further reading. 262 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 mater ials. Clean areas should be ma intained to an appropr iate
2.6.12. MICROBIOLOGICAL EXAMINATION OF NON-STERILE ...
uspbpep.comFatty products. Homogenise 10 g or 10 ml of the product to be examined with not more than half its weight of sterile polysorbate 80 or another suitable sterile surface-active agent, heated if necessary to not more than 40 °C, in exceptional cases to not more than 45 °C. Mix carefully and if necessary maintain the temperature in a water-bath
STERILE TECHNIQUE KEY CONCEPTSAND PRACTICES
www.med.illinois.educoncepts and practices for establishing and maintaining a sterile field. OBJECTIVES After viewing the video and completing the study guide, the participant will be able to: 1. Define sterile technique. 2. Identify the parameters of a sterile field. 3. Describe practices that reduce the spread of infection when preparing or working in a sterile ...