Ansell Healthcare Japan, Inc. Product Lineup

The "BioClean Clear View Autoclave Compatible Goggles BCAH" are designed for clean rooms and are made from very soft and lightweight silicone rubber to enhance wearer comfort for extended use. They feature an indirect ventilation system that reduces the risk of contamination when entering controlled environments. Additionally, they use scratch-resistant optical correction reinforced polycarbonate lenses that can be worn over glasses. 【Features】 ■ Very soft frame with an indirect ventilation system ■ Lint-free, latex-free headband ■ Scratch-resistant optical correction lenses made of reinforced polycarbonate ■ Verified to withstand over 40 autoclave sterilization cycles at 121°C/250°F for 30 minutes ■ Verified to withstand 12 gamma radiation cycles *For more details, please download the PDF or feel free to contact us.

The Kimtech M3 sterilized pouch-style face mask is made with BiCiSof fabric on the inside, providing not only protection but also excellent comfort and safety. It can be used with confidence in a sterile cleanroom of ISO Class 5 (Grade A). *For more details, please refer to the PDF document or feel free to contact us.*

The Kimtech M3 pouch-style face mask provides excellent comfort, protection, and safety for work in cleanroom environments. It is ideal for use in cleanroom environments of ISO Class 3 or higher. Additionally, the BiCoSof fabric on the inside of the mask enhances protection. *For more details, please refer to the PDF materials or feel free to contact us.*

You can choose from ear loop or string type. *For more details, please refer to the PDF document or feel free to contact us.*

With excellent bacterial filtration efficiency (BFE) and particulate filtration efficiency (PFE), it reduces the risk of contamination. *For more details, please refer to the PDF document or feel free to contact us.*

The "BioClean Clear View Single-Use Goggles BCGS1" is a sterilized product made from lightweight and very soft polyvinyl chloride. It features an indirect ventilation system that maintains a comfortable fit while reducing the risk of contamination when entering controlled environments. Additionally, it can be easily worn over glasses and provides a clear view with anti-fog and scratch-resistant optical-grade polycarbonate lenses. 【Features】 ■ Lightweight polyvinyl chloride (PVC) frame ■ Indirect ventilation system ■ Anti-fog and scratch-resistant lenses made of reinforced polycarbonate ■ Lint-free, latex-free headband *For more details, please download the PDF or feel free to contact us.

The KIMTECH products, a personal protective equipment brand of the former Kimberly-Clark Corporation integrated into Ansell in 2024, along with BioClean sterilized and non-sterilized gloves, lab gloves, protective clothing, and other chemical protective gloves specifically designed for clean rooms and controlled environments under Ansell's strict global quality management system, are included in the lineup.

Ansell Healthcare Japan will be exhibiting at Interphex 2026. In line with this year's theme, "Protective equipment supporting the entire series of aseptic processes from research and development to shipping judgment," our booth will showcase a comprehensive lineup of protective gear including KIMTECH and BioClean protective clothing, gloves, goggles, and more. We invite you to experience a variety of programs, including exclusive seminars for attendees, live demonstrations, and technical consultation sessions. ///Special Program/// ■Expert Seminar: The Biggest Risk in Pharmaceuticals is "Human Action" - Selecting Protective Clothing in Accordance with GMP Annex 1 - Mechanisms of contamination risk and the role of appropriate protective equipment - Key points of GMP Annex 1, the standards for pharmaceutical manufacturing and quality control in the European Union (EU) ■Live Demonstrations - Be amazed! How to wear protective clothing to prevent contamination? - Verification of the breathability of protective clothing affected by design and materials - New product: Acetone-resistant disposable gloves permeability resistance testing ■Individual Technical Consultation Sessions (Priority for Pre-Reservations) - Consultation on points for selecting protective equipment compliant with GMP Annex 1 and responses to the guidelines For an example of a live demonstration, please see the related videos at the bottom of the page!

This catalog is a white paper that provides a detailed explanation of the management of contamination risks from operators in a sterile environment, based on the requirements of the revised EU GMP Annex 1 (Manufacturing of Sterile Medicinal Products). It introduces key points for selecting appropriate protective clothing for cleanrooms and gloves for RABS/isolators. The revised Annex 1, issued in August 2022 and implemented in August 2023, emphasizes that "humans" are the largest source of contamination, highlighting the importance of managing operator behavior, attire, and the qualification assessment of PPE (personal protective equipment) more than ever before. This catalog organizes these regulatory backgrounds in an easy-to-understand manner and explains how to apply them in practical operations on-site.