+48 881-936-710

pleng
Contract manufacturing offer
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