The stainless steel fermenter must be designed & constructed in a manner that allows for effective cleaning and sanitization.
How we measured Sterility Assurance Level 10’-6 in fermenter ?
Standards: ASTM E1153 & ISO 17664
Appropriate methods are:
Steam sterilization & gamma Irradiation
Please guide me to regarding this and help me out for documentation
Hello Kapil, and welcome.
I can see 3 different words included here: cleaning, sanitization and sterilizaion. Since these are differente processes, each one has its own methods and requirements. In very, very, short words, cleaning is to remove particles (viable and non-viable); sanitization is to reduce bioburden (viable particles); and sterilization is to render an item sterile (i.e. free of viable particles).
From your post: “The stainless steel fermenter must be designed & constructed in a manner that allows for effective cleaning and sanitization.” This means that the fermenter is designed in such a way that it allows to be effectively cleaned and sanitized (does not mention sterilized). For example: it must allow for dissassemble major pieces to be able to clean and remove residues; and must be constructed with materiales suitable for sanitization. This requirements are demonstrated during equipment qualification.
From your post: “How we measured Sterility Assurance Level 10’-6 in fermenter?” and Appropriate methods are: Steam sterilization & gamma Irradiation" The Sterility Assurance Level (SAL) is demonstrated by achieving the lethality required for a SAL of 10’-6. In a steam sterilization, the termenter can be designed to do a Sterilization In Place (SIP) in which steam is supplied to the equipment to sterilized all surfaces via moist heat; or the equipment can be disassembled to sterilized the parts in a steam sterilizer (steam autoclave). For Gamma Irradiation you must disassemble the equipment and send it to sterilizing irradiation, this achieves SAL without putting materiales on high temperatures or humid conditions. These processes are demonstrated to achieve the SAL during validation activitires. You can follow USP chapter <1229> for detailes on how to validate these processes.
From your post: “Standards: ASTM E1153 & ISO 17664” These are not standards for sterilization. ASTM E1153 is a standard for evaluating the effectivenes of sanitizers. You must demonstrate that your sanitizers are effective on the materials you intend to use them. ISO 17664 includes information to be provided by the medical device manufacturer for the processing of medical devices that are intended to be cleaned, disinfected and/or sterilized by the processor to be made ready for use.
I hope this information is helpful.
If you have a more specific question, I may be able to assist further,
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