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EN 17141 – European Standard on Biocontamination Control
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EN 17141 – European Standard on Biocontamination Control

What happens when I order?

Download Course Description (PDF)

Price: 249 EUR excl. VAT

Duration: Approx. > 2 hours

Order total of 5 or more gets a volume discount, see discount in cart

Cleanroom Training Course - Online

”EN 17141 – European Standard on Biocontamination Control” is an on-demand Online training course that provides a personal course certificate after course completion.

Course materials included with slides from the course (PDF file to download)

Course language

The course is in English (No subtitles are currently available). 
Looking for our Swedish version? Click here
 

Course author

This course is created by Prof. Matts Ramstorp, together with Johan Ramstorp. 
 
Prof. Matts Ramstorp  is the world’s first Professor in Cleanroom Technology and Contamination Control, and he has worked with cleanrooms for over 40 years as scientist, consultant, educator and lecturer.
 
With his unique knowledge and his way of teaching, Matts has throughout the years trained thousands of people in Cleanroom Technology and GMP - always with the philosophy: “no one should be left behind”.

Course objective

The objective of this course is to provide an introduction to the EN 17141 standard. We will cover the purpose of the standard, identify which operations benefit from its implementation, and discuss all the major and general sections of the standard.

Course target group

This course is created for professionals within the pharmaceutical, medical device, healthcare, and food sectors whose work involves microbiological cleanliness and hygiene.

Course content

The course consists of 5 Parts, with multiple-choice questions after each Part. The course ties together the different parts of the cleanroom technology, and presents why cleanrooms are being used, contaminants, standards, how cleanrooms work and the impact of humans in the cleanroom.

Course length

The total course length is approximately 130 minutes, consisting of 90 minutes video modules (Parts), followed by multiple-choice questions after each Part, and finally a short survey.

Payment and time to assign/complete the course

You pay for the course license(s)* with card** or request to pay by invoice***.

You get access to the course license(s) directly after approved payment and you have 90 days to assign the course license(s) to the course participant(s) (or yourself), after which the course participant(s) has/have additional 90 days to complete the course. The courses are exclusively sold to legal entities - please see our Terms and conditions, and FAQ for more information.

Questions?

Please contact us at sales@mcleaned.com for more information. 

 

 

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* 1 course license per course participant and course
** VISA with Verified by VISA, or MasterCard with MasterCard SecureCode
*** If approved you will receive an Offer and more information via email

Watch a clip from the course

Download specifications (PDF)

Course Content

 

1. Introduction

  • Standards and guidelines
  • Pharmaceuticals and biopharmaceuticals
  • Medical devices
  • Healthcare
  • Food

17min

2. Structure, terms and definitions

  • Foreword, introduction and scope
  • Normative references, Terms and definition

15min

3. Establishment of microbiological control

  • Microbiological contamination control system quality attributes
  • Risk assessment
  • Establishing an environmental monitoring plan
  • Sampling points and sampling frequences – Action and alert levels
  • Establishment of documentation system

18min

4. Demonstration of microbiological control

  • Trending of microbiological data
  • Verification of the formal microbiological system 

9min

5. Annex A and Annex B

  • Pharmaceuticals
  • Medical devices
 13min

5. Annex C, D, E and Annex F

  • Healthcare - Hospital
  • Food
  • Agar based microbiological measurement methods
  • Rapid microbiological detection methods – RMM and AMMs
 15min