GEA Lyophil, a specialist in freeze drying pharmaceutical products, has developed a "fast track" method designed to speed up the freeze-drying process and boost turnaround times for pharmaceutical companies.
This "fast track" plant design and construction process aims to reduce the time from the start of construction to the first products streaming off the production line to a year or even less.
Time to market is often the key to success in the pharmaceutical industry and anything that can be done to reduce the time from conception to production is good for business and often good for the recipients of the drugs concerned.
The usual procedure for installing lyophilization (freeze drying) equipment would require the supplier to assemble components at its workshop, conduct the necessary Factory Acceptance Test (FAT), then take the equipment apart for transport to the factory for re-assembly and the Site Acceptance Test (SAT). This is a laborious and time-consuming exercise.
Fast Track order handling from GEA Lyophil is much quicker. It requires many activities to be transferred directly to the customer's site. Components (chamber, condenser, shelf package, refrigeration system, etc.) are made by Lyophil and its suppliers, fully tested using highly qualified staff, and then shipped to the customer. Assembly is performed by Lyophil or the customer's staff under Lyophil supervision as required. The integration of parts and final SAT all take place at the customer's site.
Fast Track is not necessarily less expensive than traditional project handling methods but it does provide a much shorter lead-time allowing the final product to be available on the market much sooner. It delivers the same high quality as all Lyophil freeze dryers, including options such us CIP, SIP, Part 11.
GEA Lyophil has already supplied plants using the Fast Track process successfully to a number of key customers who had a specific and urgent need to bring a product to market quickly. The FDA inspections done at customers" sites have all been successful.
Hubert Kluetsch, the company's director of sales and marketing, said: "I think there may come a time when this procedure will become the norm for the pharmaceutical industry."
GEA Lyophil is a member of GEA Pharma Systems - a dedicated group of leading pharmaceutical processing brands.