KOA ISEI Zao Factory
High Pharmacological Activity Injection Plant
We continually strive to precisely respond to the expectations of patients.
"From investigational new drugs to finished products"
High-quality products by high quality-control
Concept - PIC/S Compatible, Measures for Containment -
- In conformity with the ICH Harmonized Tripartite Guideline and PIC/S.
- Fulfilling measures against "Chemical Hazard Category V".
- Automatic Sterile Filling System with Isolator.
- Realizing to completely prevent contamination to humans and the environment.
- Two-stage containment by a differential pressure gradient.
- Human traffic lines completely preventing cross-contamination are ensured by the one-way traffic system of raw materials and products.
- The liquid loss can be minimized by using gravity.
- Established flexible manufacturing lines to deal with small-lot production of various products.
- Filling equipment handling single use.
- The Water supplying Equipment has sufficient capability for providing such water supply as required for C/SIP of vial-filling and freeze-drying facilities to be introduced in the future, on top of UF and WFI water production.
- The liquid loss can be minimized by installing the liquid preparing equipment on the second floor and sterile filtering/filling equipment on the first floor.
- It is possible to fill products with high pharmacological activity by installing syringe filling equipment in an isolator, realizing both "containment" and "sterility".
Overview of Zao Factory
990-2338 Japan(Zao Industrial Park)
|Site area||21,029 ㎡|
|Building area||1,917 ㎡|
|Total floor area||3,329 ㎡|
|Building structure||Two-story, Steel and ALC-panels used fire-resistant construction|
|Filling Equipment||Syringe Filling Line and Vial Liquid・Freeze Drying Lines (both corresponding to Single-Use System)|
|Manufacturing capacity||About 1.9 million (1 mL) / 1year|
|Liquid volume||25ℓ,130ℓ(Syringe line)|
|Water Supplying Equipment||4 t (WFI), 8 t (UF) (Syringe line)|
|Manufacturing items||High Pharmacological Activity injections / prefilled syringe injections (glass＆plastic)・Vial injections (glass)|