Patheon, a leading global provider of contract dosage
form development and manufacturing services to the pharmaceutical and
biotechnology industries, has recently completed a new ‘fast track’ project
with GEA Lyophil.
The project, completed in one
year from start of construction to product production, was to install new
lyophilization equipment to develop an essential new product. According to the
company the whole project was a great success.
Patheon’s development and manufacturing capabilities cover
prescription and over-the-counter (OTC) products in solid, semi-solid and
liquid dosage forms, as well as specialized capabilities in high-potency,
cephalosporin, controlled/sustained release and sterile manufacturing,
including aseptic filling and lyophilization. To meet production requirements
the company had no option but to consider a fast track approach for its latest
development project.
The usual
procedure for installing lyophilization 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 requested. The integration of parts and final SAT all
take place at the customer’s site.
Specifically, for Patheon, the fast delivery of the LYOVAC®
freeze dryers was critical.
All other vessel components
(i.e. evaporator, shelves, hydraulic cylinders) were fabricated to enable final
assembly to be performed at Patheon, not GEA Lyophil. According to Ioannis
Karanatsios from GEA Lyophil, it was teamwork that helped the project’s
success. “It was important to maintain a close co-operation between us and
Patheon,” he said. “We had regular meetings to make sure that potential
problems could be identified early and managed effectively.” The meetings
provided an opportunity for both project teams to discuss project plans and
strategy and to take part in setting the schedule. “It was very important to
find the right team members,” continued Ioannis. “They had to have the right
expertise, get on well together and be committed to the project.
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., and FDA inspections and
approval.
Sergio Steffenoni is the
European Engineering Director for Patheon who took charge of the engineering
aspects of the project and construction. He explained that the fast track
service from GEA Lyophil was the best option for them. “We had to bring this
product to market quickly and fast track was the only option,” he said. “The
whole project was completed between September 2005 and September 2006. The
commissioning was completed in this time without any major problem.”
Asked whether he would consider using
fast track from GEA Lyophil again he said that he would and that he had similar
projects planned for the near future. “I think this procedure should become the
norm for the pharmaceutical industry,” he said.
GEA Lyophil specialises in the supply of freeze drying
equipment for the pharmaceutical and biotech industries. As a member of GEA
Pharma Systems, a dedicated group of leading pharmaceutical processing brands,
it h
as acces s to the combined technologies of: Buck for contained
materials-handling; Courtoy for tablet compression; Niro for unique spray
drying systems; and Aeromatic-Fielder and Collette for reliable granulation and
drying technologies. The synergy created within the Group allows all its
members to provide comprehensive processin g systems for solid and liquid dose
manufacturing projects developed specifically to meet their customers’ needs.
END
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deutsche Übersetzung. All business enquiries to:
Hubert
Kluetsch
Director of Sales and Marketing GEA Lyophil GmbH
Kalscheurener Str. 92
50354 Huerth Germany.
Tel: +49 (0)
2233/6999-220
Email:
Hubert.Kluetsch@geagroup.com
Press Contact:
Kris De
Baere
Marketing Manager
GEA Pharma Systems
Office: +32 (0) 3
350 12 41, Mobile: + 32 (0) 473 73 19 45
Email: kris.debaere@geagroup.com