Assembly in ISO8 cleanroom

PLANT

• Highly qualified personnel, ready for challenges
• Legal manufacturer of globally marketed products
• Located near international airport
• Easy access to major road network
• MDD 93/42/EEC and EN ISO 13485:2012 compliance

 
OFFER

• Production space of 80 m2 in cleanliness ISO 8 class
• Warehouse and production space with controlled conditions
• Packaging process in ISO 5 and ISO 7 cleanliness classes
• Product welding in pouches and blisters ready for sterilization
• In-house steam sterilization
• Varied selection of packaging materials (pouches and blisters)
• FDA compliant purified water loop system
• Quality control and quality assurance services for ongoing manufacturing processes
• R&D department with innovative equipment
• Professional measuring equipment with quality certificates: interferometer, profile projectors, micron sensors, temperature sensors, temperature recorders
• Production printers with the INTERMAC software
• In-house laboratory capable of microbiology tests, ie. bioburden and endotoxin testing
• Class 2 air pressure system

 
 

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