Customised Procedure Packs

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:

• Speed of manufacture
• Simplifying the transfer process
• Ease of accessibility whilst gloved or when working in an isolator
• Following a disinfection transfer process with increased security requirements
• Ensuring medical devices are accessed in a particular sequence
• Avoiding the medical devices mixing
• Increased protection of the fluid pathway
• Removing all paper from the process
• Having the exact number of devices required for a procedure
• Generation of less waste

The AMD Customised Pack Commitment:

Qualified Components

• Confirmation of your combination and number of primary components qualifies within AMD's validated matrix and is to be packed in an existing pouch design
• Non-sterile evaluation sample produced for approval within working 5 days