Shorter lead time for better profits
Time to market is often the key to success in the pharmaceutical industry. Anything that can be done to reduce the time from concept of a process to production is good for business and often good for the recipients of the drugs concerned.
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Shorter lead time for better profits
That’s why GEA Lyophil, the GEA Pharma Systems’ specialist in the freeze drying of pharmaceutical products, has developed a unique
Fast Track process for plant design and construction that can reduce the time from the start of construction to the first products streaming off the production line to a year of even less.
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, 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 etc.
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 undertaken at customer sites have all been successful. According to Hubert Kluetsch, the company’s director of sales and marketing, the process is smooth and straight-forward. Responding to approvals from his customers Hubert said that he felt this was the shape of things to come.
“I think there may come a time when this procedure will become the norm for the pharmaceutical industry,” he said.