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 programme in accordance with ISO 14698.
Presented by: Merck Millipore/EMD Millipore (Merck Millipore & EMD Millipore are both divisions of Merck KGaA, Germany)
Speakers: Tim Sandle (Head of Microbiology at Bio Products Laboratory - UK) and Anne Connors (Field Marketing Manager at EMD Millipore)
Part 1: What you need to know about ISO 14698
Part 2: Validation of an agar plate active microbial air sampler according to ISO 14698
Date: 16 September
Time: European and Asian session 10 am CET; North America session 10 am EDT
A successful environmental monitoring programme must identify and encompass all the possible sources of contamination including people, air, surfaces and water spillages. The programme 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.
The MAS-100 family of air samplers is specially designed for monitoring microbiological contamination in aseptic production areas and isolators with the rigorous requirements of the pharmaceutical industry. All MAS-100 instruments are tested and designed to ISO 14698 guidance in validating air samplers. Methods and results for defining the physical and biological efficiency of the air samplers will be presented along with best practices for selecting agar plates used in conjunction with air samplers. The combination of instruments and results must be specifically designed for different cleanroom environments, should be able to yield the same result using the same media to allow for baseline measurements and should be fit for purpose such as particle generation, flow control, ease of cleaning and battery life.