MEDIS INTERNATIONAL a.s. 110 00 Praha 1, Olivova 4/2096 MEDIS PHARMA Bolatice Industrial zone Bolatice, region of Opava, Czech Republic In October 2008 MEDIS International a.s. started the building of a new facility for the packaging of food supplements and solid/liquid dosage forms of pharmaceuticals. 1
2.5 ha of land were purchased in the industrial zone of Bolatice village, region of Opava. Situated very advantageously close to the city of Ostrava (25 km) and Opava town (20 km). The distance to the nearest international airport Ostrava-Mošnov is 45 km. Engineering and design are in compliance with all technological requirements to achieve high standard of cgmp (current Good Manufacturing Practice) and to meet EU, FDA and local regulations. In July 2009 the assembly of air conditioning, clean rooms, media distribution and administrative facilities was completed. At present the installation of packaging line made by Uhlmann A.G. is in progress and the Application for the manufacturing authorization has been submitted to the regulatory authority in the Czech Republic (EU). 2
The facility has 2 floors: MEDIS International, a.s., Karlovo náměstí 3, 120 00 Praha 2, tel : 224 910 614 Ground-floor: consists of packaging production areas, laboratories, administration areas, changing rooms, social facilities and some auxiliary operation areas 3
First-floor: climate control, air conditioning units, compressed air and gas fired boiler 4
Production areas are designed with the aim of maximum product, staff and environment protection, and observance of all cgmp rules for packaging of drugs and food supplements. - Clean rooms of primary filling are equipped by 100% air exchange and filtration of removed air through HEPA filters H13 - Material and staff gates are operated in positive pressure towards surrounding and working areas - Remaining rooms are equipped with efficient air conditioning Class ISO 9 - Spacious changing rooms for staff, including hygiene requirements are provided The warehouse to stock raw materials and finished goods is located at the back of the building utilizing the full height (8.8 m) of the building. The storage area has a minimum capacity of 1250 pallet places in 6 pallet high racks. It is fully airconditioned, equipped with the up-to-date handling equipment and storage system including the stock items record using a barcode system. The software supports the FEFO system. 5
A fully automated blister packaging, cartooning and strapping line made by Uhlmann A.G. Germany with the capacity of 220 mio. tablets and/or capsules per year is being installed. This production line allows offering following manufacturing activities: Primary and secondary packing of tablets, soft and hard capsules into blisters both from simple PVC foil, and composite PVC/PVDC, PVC/PE/PVDC a PVC/Aclar foils Primary and secondary packing of tablets and capsules into Alu/Alu blisters Primary packaging is performed on the blistering machine Uhlmann B 1240/1647 allowing the filling of blisters in five lines side-by-side (maximum foil width 168 mm, maximum capacity up to 350 blisters /min. Packaging line is equipped with the camera test system Microchrom, enabling the colour detection. 6
MEDIS International, a.s., Karlovo náměstí 3, 120 00 Praha 2, tel : 224 910 614 Secondary packaging is performed on the cartooning machine Uhlmann C 2155/233 (max packaging capacity 150 boxes/min (max. 400 blisters/min). The line is equipped with the automatic test system, including the control of Pharma codes on the outer pack and patient information leaflet (PIL). The terminal part of the packaging line creates the strapping machine S 3025/129 with the maximum capacity 300 packaging/min enabling the strapping with the PE foil of the maximum width 150 mm. Ready available production areas make it possible for sequential extension of that capacity fourfold. Manual secondary packaging of injection forms and liquid preparations in primary packaging (eye drops, oral solutions) is also possible. 7
For the EU batch release of products fully equipped physiochemical and microbiological laboratory has been built, equipped with the state-of-the-art analytical instruments enabling the quality control of products according to the current Good Manufacturing Practice, customer s and pharmacopeial requirements (PhEur, USP), to be performed. Physiochemical laboratory is equipped with 2 HPLCs (AGILENT 1200 Series) dissolution apparatus SOTAX AT 7smart, tablet disintegrator SOTAX HT 10, dissolution testing unit SOTAX DT 2, UV spectroscope EVOLUTION 60- UV-Vis, balances by Mettler, stability cabinets Binder and the unit for the preparation of purified water Millipore MilliQ Integral 5. 8
Microbiological laboratory is equipped with the class A clean room with continuous monitoring of particles, enabling the qualified control for microbiological purity according the requirements of PhEur and also the control of the sterility of sterile dosage forms. The laboratory is equipped with the Steritest Equinox by Millipore for testing the sterility, kinetic reader Biotec ELx808IU for testing the endotoxines, sterilizers Astell and incubators Binder. 9
All areas are staffed with highly qualified end experienced employees. The GMP inspection is expected in September 2009. Production operation will be commenced in the last quarter 2009. We will welcome your inquiries to offer the most efficient and economical packaging and QC laboratory service for the pharmaceutical industry. Please contact: Mr. Petr Bulej, PhD, MBA Business development manager By e-mail: bulej@medisinternational.cz By phone: +420 724 555 141 By fax: + 420 595 171 564 10