Ansell Healthcare Japan, Inc. Industrial Division & Life Sciences Division Official site

Regarding the response to the revised EU GMP Annex 1 [Webinar Recording]

Annex1 Changes and Implications for Sterile Pharma Manufacturing

This is a recording of the webinar that was held on February 16, 2023. Sachin Yardi, Head of Quality at Enzene Biosciences, along with Avinash Vhanakaware and Alvin Lambino from Kimberly-Clark's Asia Scientific Division, provided explanations regarding compliance with the revised EU GMP Annex 1 (Manufacturing of Sterile Medicinal Products). Currently, this video is available for limited viewing, and if you would like to watch it, please contact us, and we will provide you with the link.

basic information

We also provide product samples for evaluation, so we would appreciate your consideration. For details on single-use products, please download the PDF or feel free to contact us.

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Applications/Examples of results

【Applications】 ■Aseptic preparations ■Regenerative medicine CPC ■Pharmaceutical manufacturing, etc. *For more details, please refer to the PDF document or feel free to contact us.

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[White Paper] Selection of Sterile Cleanroom Garments in Compliance with the Revised EU GMP Annex 1

TECHNICAL

Aseptic cleanroom 'Kimtech A5 Sterile Sleeve' *Sample available

PRODUCT

[Technical Document] Wearing Instructions for 'Kimtech A5 Sterile Boot Covers' for Aseptic Clean Rooms

TECHNICAL

Aseptic cleanroom "Kimtech A5 Sterile Coverall" *Sample available

PRODUCT

【Technical Document】Wearing Instructions for 'Kimtech A5 Sterile Mask Integrated Hood' for Aseptic Clean Rooms

OTHER

Aseptic cleanroom 'Kimtech A5 Sterile Boot Covers' *Sample available

PRODUCT

[Technical Document] Wearing Instructions for 'Kimtech A5 Sterile Hood' for Aseptic Clean Rooms

TECHNICAL

Aseptic clean room 'Kimtech A5 Sterile Mask Integrated Hood' *Sample available

PRODUCT

【Technical Document】Aseptic Wearing Procedure for 'Kimtech A5 Sterile Coverall' for Aseptic Clean Rooms

TECHNICAL

[White Paper] Kimtech SMS Nonwoven Single-Use Wear vs. Reusable Cleanroom Wear

TECHNICAL

[White Paper] Regarding the Introduction of Single-Use Wearables

TECHNICAL

[White Paper] Cleanroom Wear Designed for Aseptic Use

TECHNICAL

[Technical Document] Wearing Instructions for 'Kimtech A5 Sterile Boot Covers' for Aseptic Clean Rooms *New Poster*

TECHNICAL

[Technical Information] Wearing Instructions for 'Kimtech A5 Sterile Mask Integrated Hood' for Aseptic Clean Rooms *New Poster*

OTHER

[Technical Information] Wearing Instructions for 'Kimtech A5 Sterile Sleeves' for Aseptic Clean Rooms *New Poster*

OTHER

[Technical Information] How to Remove 'Kimtech A5 Sterile Boot Covers' for Aseptic Clean Rooms *New Poster

TECHNICAL

[Technical Information] How to Remove 'Kimtech A5 Sterile Sleeve' for Aseptic Clean Rooms *New Poster

OTHER

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Ansell supports the safety of over 10 million people in more than 100 countries around the world, accumulating extensive experience, transparent data, and know-how through the provision of protective gloves, protective clothing, and solutions in various environments. Based on this, we anticipate our customers' needs and provide products and services that predict, prevent, and protect against risks in the workplace, thereby supporting the realization of a safe and sustainable work environment. In addition to Ansell's core brands such as HyFlex, BioClean, MICROFLEX, and AlphaTec, we will acquire Kimberly-Clark's personal protective equipment (KCPPE) business in 2024, adding the KIMTECH brand to our lineup. This will enable us to meet the increasingly diverse and sophisticated needs of customers in industries such as pharmaceuticals and semiconductor manufacturing.