MEDIS INTERNATIONAL a.s. 110 00 Praha 1, Olivova 4/2096 MEDIS PHARMA Bolatice Industrial zone Bolatice, region of Opava, Czech Republic MEDIS International a.s. started to build a new facility in October 2008 for the packaging of food supplements and solid/liquid dosage forms of pharmaceuticals. The facility is located 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 GMP (Good Manufacturing Practice) to meet EU, FDA and local regulations. 1
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 First-floor: climate control, air conditioning units, compressed air and gas fired boiler The air-conditioned 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. Production areas are designed with the aim of maximum product, staff and environment protection, and observance of all GMP 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 the HEPA filters H13 - Material and staff gates are operated in positive pressure towards surroundings and working areas - Remaining rooms are equipped with efficient air conditioning Class ISO 9 - Spacious changing rooms for staff, including hygiene requirements are provided - Air conditioned storage areas are equipped with 6 pallet high racks, a collating system and up-todate handling equipment - Laboratory areas are designed to adhere to principles of good laboratory practice Construction works have been initiated in October 2008. 2
In the end of 2008 the shell was topped-out. 3
MEDIS International, a.s., Karlovo náměstí 3, 120 00 Praha 2, tel : 224 910 614 In the beginning of 2009 the floor preparation was finished and the assembling work inside the premises started. 4
At present (May 2009), the assembly of clean rooms, air conditioning and the media distribution is in progress. 5
A fully automated blister packaging line made by Uhlmann A.G. Germany with the capacity of 220 mio. tablets and/or capsules per year will be installed in the factory building. Ready available production areas make it possible for sequential extension of that capacity fourfold. This production line will allow 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 Secondary packaging of parenterals and liquid preparations in primary packaging The constructed storage area with the minimum capacity of 1250 pallet places will be fully airconditioned, equipped with the storage system including the stock items record using a barcode system. The software will support the FEFO system. 6
For the release of products fully equipped physiochemical and microbiological laboratory are being built. The building inspection is planned for July 2009. 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 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: + 420 224 910 614 7