Quality
WATSON・FUKAEKASEI >  Quality

ISO9001, ISO13485

Quality policy

The Fukae-Kasei Co., Ltd. Group aim to become a top company in the life science and medical fields using plastic molding technology. We will become an essential company for the realization of a plentiful and comfortable way of living and the growth and development of both scientific and technological innovation through the symbiosis of people and nature.

 

1.We will always seek the ways in response to the customer focus by supplying with more functional laboratory products which they constantly want to order. We will make the best use of our technique and knowledge in plastic characteristic so that entire satisfaction may be ensured for variety of customers.

2.We will establish quality management system, will analyze and make an evaluation of our company activities and its condition, then will improve the effectiveness on our system constantly.

3.We will review quality objectives and business plan through company, from the whole to the details, then we will re-evaluate them once per year.

4.We will set out to make our WATSON brand recognized a first leading company in the field of plastic laboratory products over the world.

Certificate of Registration, Quality Management System - ISO13485

Fukae Kasei was certified ISO 9001 in 2007, which is the international standard of quality assurance, since then we have manufactured high quality products under strict quality control. In addition, we were also certified ISO 13485 in 2015 to be met with our customer’s request which is the research and development for medical use.
We will continue our research and development to provide indispensable products not only in the field of bioscience, but also in the field of medicine that supports our health. To go beyond customer satisfaction, we will continue our research and development to provide indispensable products in the medical field that supports our health beyond the bioscience field.

Fully equipped clean room and Well-developed production system

Our consumables products are fully committed to serving our customers who research or test biological material such as DNA. Therefore, we strictly built and maintain our clean room to minimize contamination risks. In addition, we are introducing automation technique into our manufacturing line and trying to reduce manpower allocation as much as possible. We try to do our best to maintain high cleanliness in our all facilities.

See Also
RNase / DNase FREE Human DNA FREE, Pyrogen Free
Quality Guarantee

Clean room

クリーンルーム

クリーンルーム

FUKAE KASEI has set Class 100,000 clean room where our molding machines are set under high cleanliness criteria so as to manufacture the products that ensure RNase/DNase/Human-DNA free. Only certified staff are allowed to enter clean room where the cleanliness criteria is strictly controlled. Our second factory has also a higher standard one, Class 10,000 where more high standard manufacturing is feasible.

Automated production line

自動化された生産ライン

We promote automated production line so that we are able to provide a stable supply of high-quality products to the customers.
Automation enables to improve work efficiency and decrease contamination risks as much as possible comparing to the machine with manpower.

Our Equipment

Equipment:

Injection molding machines

Vertical Injection Molding Machines

Automated Machine Series:

for loading tips into a rack,

for packing in line,

for cap closing (in typical items),

for O-ring insertion,

for filter inserting into a tip, etc.

Processing Machines:

High-precision die and mold machining, YBM 950V Ver. III

Lathe, Radial Drilling Machine, Polishing Machine, Milling Machine,

Surface Modified Machines

Individual Packaging Machines

In addtion, there are 9 originally designed automation machines which covers overall proceses from molding to filter insertion.

These automation machines are in-house designed and assembled, and they offer advantages such as reduced cycle time, maximized production efficiency, detailed adjustments, and application to other products.

Our human resource: – many personnel certified in plastic molding expert testing!

プラスチック成形技能検定有資格者が多数在籍

We believe advanced machinery and outstanding workspace will generate more and better products.
Moreover, it is essential to secure the experts who are able to maintain machinery or equipment. From this perspective, FUKAE KASEI actively drives forward to train employee.
Especially in the operators who handle the molding machine, FUKAE KASEI makes them train and apply the plastic molding expert official examination held in Japan every year. Now some operators in the factory passed this examination and operate the facility in good condition.
Furthermore, we positively hold workshops related the introduced machines to aim for better understanding of production facility, which follows we are able to manufacture better-quality products.

Quality Control System

品質管理体制

Before being placed on the market, each product is periodically tested by the experts in testing equipment so as to be met our quality standard.Each sampling is stored for 6 months, and its testing data is recorded for 3 years. Therefore, we are flexibly support each order after the shipment in case of any possible failure.
Testing tools and equipment are calibrated in accordance with ISO quality manual, and the reference tools and equipment are also periodically calibrated by the third party.

Quality Guarantee

Our most Watson branded products’ grade is Nuclease-Free. In terms of the products domestically manufactured, we are the first company who actualized our products with Nuclease-free. We are also able to provide the customized products with Nuclease-Free grade. Beside, we have another product line with Pyrogen free or Irradiation. Please feel free to ask us if there are any further questions about inspection contents.

RNase / DNase FREE Human DNA FREE

ヌクレアーゼ・フリーマーク

RNase/DNase Free Test

Test sample in a sealed container is sonicated with RNase/DNase FREE water. The extract after sonication is tested by the kit and the products are free of DNase/RNase contamination.

Human DNA Contamination Test

The extracted Human DNA from the sonicated products is amplificated by Real Time PCR by using primers which amplify human genomes. The DNA concentration is confirmed ≤ 1 pg/µL.

Pyrogen FREE

パイロジェン・フリーマーク

Endotoxin Test

Endotoxin level is confirmed ≤ 0.05 EU/mL by Endotoxin chromogenic. Test method is referred to The Japanese Pharmacopoeia.

Irradiation Sterilization

放射線照射滅菌済

Irradiation Sterilization

The product has been irradiated.

Sterility Test

無菌試験

Sterility Test Method

Test samples and bag for product packing are cultured in liquid culture medium of test tube. Culture condition is the temperature 30-35℃. The result is reviewed by cheking bacteria growth both 7 days later and 14 days later.

Ethylene Oxide Gas Sterilization

EOG滅菌済

Ethylene Oxide Gas Sterilization

No growth of bacteria was found by culture examination test In house test. Sterilization conditions: temperature 50℃ (122℉), relative humidity 50%, EO concentration 20%. After EO gas treatment during 5-6 hours, EO gas is replaced with atmosphere.


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