COMPANY
PRODUCTS
R&D
NEWS & EVENT
SERVICE
Have sterile-workroom and manage production
process with the best clean system through
regular monitoring.
Acquire FDA, CE, ISO13485, and KGMP which are
internationally stability proven certification due
to strict production guidelines.
Production and management directly from
BISTOOL’s headquarter to ensure the same quality
of products anywhere in the world.
Provide the best product development service
through a skilled R&D team with their full experience
and know-how.
| 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.