Standardization of Disposables Design

Due to resent advances there is an opportunity for PM Group to develop with the suppliers a portfolio of standardized part drawings. These drawings ensure there is compatibility between multiple vendors. This design opportunity has knock on benefits for the end users. One of the biggest challenges or barriers to further disposables implementation today is the lack of harmonized industry standards whether it be in the field of leachables and extractables testing, quality, equipment design or manufacturing standards. Significant advances are being made in all of these areas by multiple organizations, including the ISPE. This presentation will focus on the area of disposables design and PM Groups efforts to work with suppliers to remedy the situation. Components in use within single-use (disposable) equipment and systems are typically defined by each vendor. Understanding the differences between different vendors approaches is important as not all vendors equipment and systems are compatible with each other. Opportunities are arising which facilitate standardization of the approach to designing and using these components, and towards this end PM Group has been developing an approach, in conjunction with the vendors, to allow a more standardized approach going forward.