There is always some probability that a microorganism can survive regardless of the extent of treatment applied. It is crucial to characterize the probability of survival of the microorganisms present.
Bioburden is the sum of the microbial contributions from numerous sources, including raw materials, manufacturing, assembly processes, manufacturing environment, assembly aids, cleaning processes, and packaging of finished products.
By directing attention towards these processes, bioburden can be useful for validating sterilization processes, control of manufacturing processes, monitoring raw materials or components, assessing the efficiency of cleaning processes, and an overall environmental monitoring program.
Does this only apply to products manufactured going forward from the date of manufacturing under this new certification or does the compliance apply to those with prior date of manufacturing of such product? Your email address will not be published. This site uses Akismet to reduce spam. Learn how your comment data is processed.
Sterilization of Health Care Products — Microbiological Methods Bacteria and other microorganisms are plentiful, more so than many of us like to think. Clarified that package testing is not typically done unless it is an integral part of the product. Buy this standard. Abstract Preview ISO specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.
Status : Published. Publication date : This standard contributes to the following Sustainable Development Goal :. CHF Buy. Life cycle Previously Withdrawn. Confirm selection Select all. Please select from Publication date Original language English Pages 48 Product information on this site:.
Quick delivery via download or delivery service. All transactions are encrypted. ICS Cooperation at DIN Please get in touch with the relevant contact person at DIN if you have problems understanding the content of the standard or need advice on how to apply it.
0コメント