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

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

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last updated:Mar 11, 2025

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

    mask
IPROS55316518547279479930.jpg

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

IPROS55316518547279479930.jpg
IPROS55316518547279479930.jpg
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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

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

TECHNICAL
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Aseptic cleanroom 'Kimtech A5 Sterile Sleeve' *Sample available

Aseptic cleanroom 'Kimtech A5 Sterile Sleeve' *Sample available

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

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

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Aseptic cleanroom "Kimtech A5 Sterile Coverall" *Sample available

Aseptic cleanroom "Kimtech A5 Sterile Coverall" *Sample available

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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[White Paper] Cleanroom Wear Designed for Aseptic Use

[White Paper] Cleanroom Wear Designed for Aseptic Use

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

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

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

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

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

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

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

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

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

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

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Ansell

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

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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.

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