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Quality Management Inspection Department

Inspection department

About the laboratory

Since 2010/2, the post-process cleaning, inspection, and packaging work will be fully operational in the D building (former Tsukinukizawa No. 2 Factory) in the current head office factory, which was renovated to be more suitable for needle manufacturing, and the final process inspection The department is managed in a clean environmentally controlled area of ​​class 10,000, and the needles that have been "cleaned" in the cleaning process are handled by certified inspectors and weighing wrappers in the inspection room so that particles (fine particles) do not adhere to the needles, 100% inspection prevents abnormal outflow of needles. (The environmental management class required for running a business may be ISO cleanliness class 8 (class 100,000), but we are doing more environmental management)

State of the examination room

Inspection room entrance air shower unit
Inspection room entrance air shower unit
Before entering the environmentally controlled area, we take an air shower and use an adhesive mat on the floor to prevent particles from entering the inspection room.
Environmentally controlled area equivalent to class 10,000
Environmentally controlled area equivalent to class 10,000
Every 3 months, the particle counter measures the inspection room and packaging room to monitor the area for proper environmental control. In actual measurement, the cleanliness is comparable to class 10,000.
Class 10,000 means an ISO Cleanliness Class of 7, where per 1 cubed foot of air (30 cm cubed), all particles of 0.5μm total less than 10,000 in number, and it is said that the environment is close to the cleanliness near the summit.
Controlled area photo 1
Controlled area photo 2
Controlled area photo 3
Controlled area photo 4
Pre-shipment cargo packaging
As a result of strict 100% visual inspection, normal needles are shipped as acceptable products.There are several types of carton shapes depending on the shipping form.The carton size in the photo is about 25 cm cubic.

Kaneko MediX, Inc.
Tochigi Prefecture, Nasushiobara City, Tsukinukizawa 342-17
TEL. +0287-36-6688-XNUMX
FAX: 0287-36-5827

Manufacturing of medical injection needles

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