“Speed is irrelevant if you are going in the wrong direction” -Mahatma Gandhi

For parenteral products, sterility is a key product attribute for product safety. The key words in Advances and challenges in Sterile Formulation, Manufacturing and Regulatory aspects show –

• Drug Safety
• Endotoxins
• Process Controls
• Safe Use
• Sterilization

A key word we forget here is RFT (Right First Time) facility design EARLY in the project, capable of delivering all of the above. As we fondly tell all our industry friends in Sterile Pharma - Sterility starts from the outlet of WFI system and has to be sustained till the drug is dispensed in a filling machine. The WFI produced in WFI generator –

Unless - not stored and distributed well,

Unless – not dispensed in sterile & efficient manner to the Process skids,

Unless – not formulated in process skids appropriately,

Unless – not seamlessly transferred to filling machines

Most projects of the past assumed great speed while ordering Water systems, Process Skids, Filling Machines, TCU’s etc. The key elements of design which are important and often overlooked are the integration/ handshake between each of these systems. Many times they come as an afterthought or incorporated in design much later with initial assumptions that these integration can be managed at later stages of projects. The advantage of speed & momentum achieved earlier quickly is lost out either during detailed engineering & post ordering of these equipment OR worse after the equipment have arrived at site. The last mile connect as they say, usually takes the longest to cover and invariably becomes the show stopper!

Solution – Shifting focus from Speed to Timing

The integration of Clean utilities with Process Skids have to be anticipated and built in design before orders are released (for Water systems, Process Skids, Filling Machines, TCU’s etc.) with clear mechanical, process, software & validation boundaries as well as handshakes well defined. Many Ampoule, Vial, PFS filling machines are difficult to re-design integrate post-supply. This way of pre-empting the integration challenges and incorporating early in design may take time, the ordering may take time; however saves precious amount of time and cost at CQV stages of the project. We at Praj Hipurity are trying to ingrain this in our way of life based on our various experiences with different clients, suppliers, etc.

Lastly, the need of speed is somewhere else. Nothing is as fast as TRUST.

You can trust Team Praj Hipurity to help you with the right integration & handshake designs early in the Project phase either Pre-order or Post-order engineering.