BISTOOL

RESEARCH & DEVELOPMENT

MANUFACTURING ENVIRONMENT

Production process management and
medical device regulation compliance

  • 1

    Have sterile-workroom and manage production
    process with the best clean system through
    regular monitoring.

  • 2

    Acquire FDA, CE, ISO13485, and KGMP which are
    internationally stability proven certification due
    to strict production guidelines.

  • 3

    Production and management directly from
    BISTOOL’s headquarter to ensure the same quality
    of products anywhere in the world.

  • 4

    Provide the best product development service
    through a skilled R&D team with their full experience
    and know-how.

[ Manufacturing Environment based on ISO and GMP ]

Cleanroom cleanliness management - Required cleanliness standards of medical device manufacturers

Standard Particles (0.5㎛/ft3) Floating microorganisms (CFU/㎥) Falling microorganisms (CFU/9㎝ø/4hrs) Surface (CFU/55㎜øplate) KGMP
ISO 5 Class 100 < 1 < 1 < 1 Aseptic work
ISO 7 Class 10,000 < 20 ≤ 5 ≤ 5 Aseptic product workroom and
aseptic work management area
ISO 8 Class 100,000 < 200 ≤ 50 - Sterilized product workroom
Standard Particles (0.5㎛/ft3) KGMP
ISO 5 Class 100 Aseptic work
ISO 7 Class 10,000 Aseptic product workroom and
aseptic work management area
ISO 8 Class 10,000 Sterilized product workroom
Standard Floating microorganisms (CFU/㎥) Falling microorganisms (CFU/9㎝ø/4hrs) Surface (CFU/55㎜øplate)
ISO 5 < 1 < 1 < 1
ISO 7 < 20 ≤ 5 < 5
ISO 8 < 200 ≤ 5 -

※ SOFTXiL is strictly manufactured and managed as a Class 10,000 which is equivalent to medicine standard.

Test method for cleanliness management

  • ① Particle measurement : Measure the floating particle using particle measuring equipment
  • ② Floating microorganisms Measurement : Cultivate the microorganism in the air and measure the bacterial contamination in the air
  • ③ Falling microorganisms : Measure the falling microorganisms by cultivating bacteria and fungi using petri-dishes
  • ④ Microorganisms on surface : Measure the microorganisms by cultivating bacteria of the workbench, wall, container, and gloves of the workers