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Contract manufacturing

Apart from the standard assortment of our own range of products we offer to our customers a possibility of contract manufacturing, especially in the field of medical devices. Our manufacturing premises located in Roznov pod Radhostem are equipped with quality manufacturing technology that meets requirements of ISO 9001, 13485 and GMP. We hold certificates for drugs and medical devices production that were issued by certified companies ITC - Zlin and SUKL - Praha.

Services offered for contract manufacturing

  • water for injections production and filling into plastic bags (capacity up to 3600 l/day)
  • sterilisation by wet steam (FEDEGARI sterilizer - volume of the chamber 2400 l)
  • filling water solutions into plastic bags of a volume between 1000 and 5000 ml (500 000 l/year) or PE canisters of a volume of 5 or 10 litres (4 000 000 l/year)
  • vacuum packing of materials - max. dimensions 50 x 50 x 30 cm

We produce under the conditions of Good Manufacturing Practice, cleanliness class C.

Contact person: Ing. Pavel Sebecek

E-mail: pavel_sebecek@meditespharma.cz

Our inspection laboratory can provide you with

  • microbiological air monitoring in your clean room - BIOTEST RCS+ machine
  • evaluation of contamination by particles below visibility level - particles in size of 10 and 25 µm - ACCUSIZER 780 SIS - CL 2005 machine
  • bacterial endotoxins trial for purified water and water for injections – limit gel trial according to CL 2009

Contact person: Ing.Radmila Dolezelová (quality manager)

E-mail: radmila_dolezelova@meditespharma.cz