The elimination of cleaning and cleaning validation is a significant benefit of disposable processing. Cleaning process equipment consumes time and valuable operator resources. Cleaning chemicals require suitable handling systems for the delivery and disposal of the fluids. Care must also be taken to use these chemicals in the appropriate concentrations to ensure that they perform their specified function.
Complicated cleaning processes are cumbersome to document, and it is even harder to prove that traces of the cleaning chemicals have been removed. Instead of having to prove that the cleaning has been effective, disposable systems are used one time and discarded. Gaps in cleaning validation documentation can cause regulatory scrutiny, and in the worst case, production of new or existing products is delayed.
Disposable systems also offer drug developers an alternative in terms of sterilization. While stainless steel systems are confined to steam sterilization processes, either autoclave or steam-in-place (SIP) disposable systems can be purchased pre-sterilized by gamma irradiation. Existing steam sterilization processes can also be used for the disposable capsule filters. Most capsule filters can be subjected to sterilization by autoclave, and some capsules (which have suitable materials of construction) can also be subjected to SIP.
Disposable products that are supplied pre-sterilized by gamma irradiation eliminate the need for sterilization and sterilization validation procedures and can reduce the maintenance of sterilization equipment. While the cost of sterilization by gamma irradiation is comparable to that of traditional steam sterilization methods, the gamma irradiation process reduces labor, and circumvents many of the potential issues associated with in-house steam sterilization.
From: “Life Sciences: Single Use Products Dispose of Cleaning”