Quality backed by reliable production and quality control system within the group’s factories.

The mainline plastic life science experimental consumables of WATSON brand are manufactured by the group company, Fukae-kasei Co., Ltd.
Watson Co., Ltd. and Fukae-kasei Co., Ltd. closely collaborate, integrating customer feedback and expertise in life science and plastic product manufacturing to maintain and enhance the quality of the WATSON brand in production.

Quality Assurance

Quality Policy

At Fukae-kasei Co., Ltd., we aim to become an indispensable presence in achieving the realization of the No. 1 comprehensive enterprise in the biotechnology field using plastics. Through the symbiosis of people and nature, we strive to realize the development of natural sciences and a rich and comfortable life.

  • We aim to improve customer satisfaction by leveraging the characteristics of plastics with excellent technology to deliver more convenient experimental equipment.
  • We establish a quality management system and regularly diagnose and evaluate the activity status to continuously improve the effectiveness of the system.
  • We set quality objectives and business plans for the entire company and each department, and conduct an annual review.
  • We aim to make WATSON a top global brand by focusing on brand, price, quality, and comprehensive quality improvement.

ISO9001 and ISO13485 quality management certification acquired.

Fukae-kasei Co., Ltd. has obtained ISO9001 and has been producing high-quality products under strict management. We have acquired ISO13485 in 2015 to meet the demands for developing medical-grade products.
We will continue our research and development efforts to provide increasingly essential products not only in the latest field of bioscience but also in the medical field, which supports the health of many people.

Quality Control System

The products undergo regular (up to every 4 hours) pull-out inspections by personnel skilled in handling inspection equipment to rigorously check compliance with quality standards.The inspected pull-out samples are kept for 6 months, and inspection records are retained for 3 years, ensuring that any issues can be addressed in case of trouble with batch numbers and shipping dates.
The inspection tools and equipment are calibrated in accordance with the ISO quality manual, and the calibration standards for calibration are also regularly calibrated by third-party agencies.

Quarity 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.
Upon request, a test report can be issued for each batch of these products. For more details, please inquire through the “Various Test Report Issuance Application Form”.

  • RNase / DNase FREE Human DNA FREE

    RNase/DNase Measurement Test Methods

    We place the test object and RNase/DNase-FREE water in a sealed container and perform shaking extraction.
    The extracted solution is evaluated using a detection kit to confirm that it is below the detection limit value.

    Human DNA Measurement Test Method

    We conduct amplification confirmation by real-time PCR using primers to amplify human genomic DNA from the human DNA measurement samples extracted by shaking from the product. We confirm that the estimated DNA concentration from the measurement sample is 1 pg/µL or less.

  • Pyrogen-Free

    Endotoxin Testing Method

    We confirm that it is 0.05 EU/mL or less using the endotoxin test colorimetric method, referring to the Japanese Pharmacopoeia.

  • Irradiation Sterilization

    Irradiation Sterilization Method

    Based on in-house test results, we conduct manufacturing management of sterilized products.

  • Sterility Test

    Sterility Test Method

    We prepare media for tube culture and use it for liquid culture evaluation of products and product bags.
    Cultures are incubated at 30-35 °C. Results are assessed by confirming microbial growth 7 and 14 days after incubation.

  • Ethylene Oxide Gas Sterilization

    Ethylene Oxide Gas Sterilization Method

    We confirm internally that there is no bacterial growth (negative) in the culture test.
    In an environment with sterilization temperature of 50 °C and humidity of 50%, 20% EO is applied for 5-6 hours, followed by air replacement.

Production System

Plastic products in the life sciences field require different expertise than general plastic products.
Therefore, in order to maintain and improve quality, we are working internally to address factory environment improvement, automation design and manufacturing of production lines and automated machinery, mold design and manufacturing, and training of operators with high-quality consciousness.
Additionally, starting from 2023, the company responsible for manufacturing reagents within the group has begun full-scale operations, allowing us to establish a framework to more comprehensively meet a wider range of needs.
Watson Co., Ltd. and WATSON branded products will respond to customer solutions through the comprehensive capabilities of group companies including Fukae-kasei Co., Ltd.

Clean Room

Automated Production Equipment

Qualified Plastic Molding Technicians

Manufacture of Automated Dispensing Devices