Biocontamination Control Webinar

Establishment of processes to avoid, monitor and react to contamination events is essential for the pharmaceutical manufacturing environment. To ensure consistency and guide manufacturers, ISO 14698 defines international standards related to biocontamination control in cleanroom and controlled environments. The guidelines specify the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved.

This webinar will provide an overview of ISO regulations and offer best practices for setting up a robust environmental monitoring program in accordance with ISO 14698. 

A successful environmental monitoring program must identify and encompass all the possible sources of contamination including people, air, surfaces and water spillages.  The program must then address a number of considerations including:

• The cleanliness level required at each site to be sampled
• Which types of samples are appropriate (e.g., air or surface samples)
• The choice of sample locations based on the nature of the work to be carried out and the impact that cleanroom operators and equipment will have
• The quantity of samples to be taken
• The time of sampling such as that after a cleaning, testing at the end of shift, testing at times of highest operator activity or high levels of materials in an area
• The frequency of sampling based on a risk management approach
• Strategies for effective data handling and trending.

The second part of the webinar will feature results from a study validating an agar plate active microbial air sampler according to ISO 14698. 

Date:

September 16

Time:

European and Asian session: 10 am CET

NA session: 10 am EDT

Part 1:  What you need to know about biocontamination control according to ISO 14698

Part 2:  How we can help you stay compliant to ISO 14698

Register for live event:

European and Asian session

North American session

Presented by Merck Millipore / EMD Millipore (Merck Millipore & EMD Millipore are both divisions of Merck KGaA, Germany); Tim Sandle (Head of Microbiology at Bio Products Laboratory - U.K); and Anne Connors (Field Marketing Manager at EMD Millipore).