Insights from Experts

The New EU GMP Annex 1 Revision 2017

The expertise to address your application needs

As experts in good manufacturing practice regulations (GMPs) for microbiology and environmental monitoring, we help you improve aseptic processes when and where you need it most.

See below to find some relevant papers written by our experts, products for your industry, and services that we can provide you with.

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Information Focus

Information Focus

Upcoming Webinar: Understanding 21 CFR 11 and Data Integrity Regulations

Attend this webinar to learn:

  • How to minimize the risk of non-conformances by understanding your processes
  • The importance of cultivating an ethical approach to data management
  • How to become and stay compliant, and prepare for future standard changes

What's included with the webinar?

  • Certificate of Attendance
  • Related Papers
  • Recorded Webinar

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Products

Airnet II 4 Channel 空氣粒子感測器

Airnet II 4 Channel 空氣粒子感測器

符合 ISO 21501-4 規範,可測量懸浮在空氣中之粒子的大小和數量,以即時監測 造成產品缺陷的粒子。

Airnet II(s) 2 Channel 空氣粒子感測器

Airnet II(s) 2 Channel 空氣粒子感測器

符合 ISO 21501-4 規範,可測量懸浮在空氣中之粒子的大小和數量,以即時監測 造成產品缺陷的粒子。

 

BioCapt® 微生物採樣頭

BioCapt® 微生物採樣頭

可在合適的培養基表面捕獲微生物活性粒子,以利後續進行培養和計數。

Lasair® III 攜帶式空氣粒子計數器

Lasair® III 攜帶式空氣粒子計數器

業界最高水準之攜帶式空氣粒子計數器,並符合 ISO 14644-1:2015 和  ISO 21501-4 的要求。

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