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 -

  1. In conformity with the ICH Harmonized Tripartite Guideline and PIC/S.
  2. Fulfilling measures against "Chemical Hazard Category V".
  3. Automatic Sterile Filling System with Isolator.
  4. Realizing to completely prevent contamination to humans and the environment.
  5. Two-stage containment by a differential pressure gradient.
  6. Human traffic lines completely preventing cross-contamination are ensured by the one-way traffic system of raw materials and products.
  7. The liquid loss can be minimized by using gravity.
Manufacturing Facilities
  • 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".
  1. ● Water Supplying Equipment
  2. ● Liquid Preparing Equipment
  3. ● Automatic Sterile Filling System with Isolator
  4. ● Sterility Testing Isolator

Overview of Zao Factory

Location 2-1-7 Zao
Matsugaoka,Yamagata-shi,Yamagata
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)