Mark Crawford, Contributing Writer06.02.15
Medical device manufacturers want all aspects of design, development and production to be faster, safer and cheaper. This includes sterilization and packaging, which often are overlooked or under-estimated as critical parts of the entire production process. Not only are there more stringent regulatory requirements for sterilization and packaging, but there also is increasing pressure on contract manufacturers from OEMs to use technological advances for data analysis, recording, reporting, review and validation.
One way to reduce costs is to improve best practices and cut out unnecessary steps that waste time and materials, and add cost.
For example, what really determines sterility assurance levels (SAL) or how sterile a product needs to be? Does a SAL of 10-3 provide enough assurance of safety and sterility? Does a SAL of 10-6 provide an excessive amount of security—which can drive up costs? And how does SAL vary with the type of device? Another area of cost control is refining the terminal sterilization of packages and drugs so that the process requires a smaller dose than what is currently accepted. Using a smaller precise dose of
One way to reduce costs is to improve best practices and cut out unnecessary steps that waste time and materials, and add cost.
For example, what really determines sterility assurance levels (SAL) or how sterile a product needs to be? Does a SAL of 10-3 provide enough assurance of safety and sterility? Does a SAL of 10-6 provide an excessive amount of security—which can drive up costs? And how does SAL vary with the type of device? Another area of cost control is refining the terminal sterilization of packages and drugs so that the process requires a smaller dose than what is currently accepted. Using a smaller precise dose of
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