Microbiological Considerations in Cleanroom Validation
Sponsored by: Wickham Laboratories Ltd.
Date: 20 March
Time: 3PM London/11AM New York
Requirements for Ongoing Monitoring of Cleanroom Environments
This webinar will provide an overview of the applicable grading systems and standards as well as reviewing some of the key considerations when developing an environmental monitoring programme, including data trending and the importance of disinfection rotation procedures.
Contamination, microbiological or otherwise, is a major safety concern in the development and manufacture of all pharmaceuticals and medical devices. Ensuring that the product or device has been manufactured to any relevant pharmacopoeial regulations and is within any specified microbial limits should be top of mind when considering the effect of a contaminated product in the market.
As part of this presentation, our speakers will discuss how cleanrooms and other controlled environments play a vital role in manufacturing and testing processes through the control of airborne and surface contamination.
We will also cover a variety of different factors including the importance of a robust environmental monitoring programme and the risk assessment considerations that must be undertaken to best identify any possibility for contamination in your facility. In addition, we will review a case study on a cleanroom qualification project completed recently.
Given aseptic processing relies on the prevention of microorganisms from entering products or test systems during testing or manufacturing, it is evident that these considerations must not be taken lightly as the impact can be devastating to both the end users and the companies involved in the product life cycle. Join us as we discuss the microbiological aspects of cleanroom validation and ongoing monitoring which must be considered in order to ensure your facility is fit for purpose.
Microbiology Business Support Co-ordinator
Tazmin first joined Wickham Laboratories Ltd in 2004, with a keen interest in the science industry. Over the past decade, she has progressed through various roles within the microbiology validation team, gaining experience, scientific qualifications and a deep understanding of a wide variety of pharmaceutical and medical device products for microbiological testing.
In 2017, Tazmin transferred from her position as Senior Technician to her current role as a Microbiology Business Support Co-ordinator, providing key account management for existing and new clients across the company’s entire range of microbiology services.
Senior Technician, Microbiology Quality Control
Jack has been with Wickham Laboratories Ltd since 2016 and currently works in our quality control (QC) department as a Senior Technician, responsible for scheduling of routine QC testing as well as acting in a supervisory capacity for the technicians within the department.
Working in our microbiology laboratory has allowed Jack to grow and develop his skillset for the QC testing of both pharmaceutical products and medical devices.
Part of Jack’s role also involves travel offsite to perform routine environmental monitoring activities at various client facilities.
Key Learning Objectives
- Cleanroom grading systems and standards
- How to plan an effective environmental monitoring programme
- Considerations in risk assessments and importance of data trending in environmental monitoring
- Importance of disinfectant validation and rotation in cleaning procedures
- Business Development Manager/Supervisor
- Commercial Director
- Head of Microbiology
- Head of R&D
- Lab Manager/Supervisor
- Process Support
- Project Manager
- QA Associate/Scientist
- QC Manager/Technician/Scientist/Associate
- Quality Director/Manager/Supervisor
- Qualified Person (QP)
- R&D Team Leader/Scientist
- Regulatory Manager/Supervisor
- Research Manager/Supervisor/Scientist/Associate
- Senior Laboratory Analyst
- Senior Microbiologist
- Senior Scientist
- Technical Lead
- Technical Manager
- Technical Support