Many times an aseptic procedure may call for a combination of devices/components which do not exist within AMD's standard configuration of products. At this point it is worth considering a bespoke approach.
In the aseptic preparation and transfer of drug formulations, users of the necessary medical devices may have a 'wish list' of the ideal number of components and/or combination of several different components in differing pouch designs and numbers of protective layers of packaging. AMD works with users to create a New Product Request Form (NPRF).
Many components that have been fully qualified and subject to total bioburden and technical review may be 'mixed and matched'.
The scope of the NPRF could involve:
The AMD Customised Pack Commitment:
Qualified Components