Search
Contamination Control Strategy Resources
Thank you for submitting your request. Your resource is now available for download, along with some additional materials related to aseptic processing simulations and environmental monitoring that may be of interest:
SmartNotes:
Risk-based approach to selecting environmental monitoring locations
Dr. Tim Sandle's SmartNote series discusses how a risk-based approach to environmental monitoring helps facilities maintain control over their environment and supports quality assurance efforts. Plus, they highlight the importance of selecting appropriate monitoring locations and taking proactive measures based on monitoring results to ensure consistent environmental quality and mitigate potential risks to product safety and integrity.
Download Part 1: What do we want to achieve with our environmental monitoring program?
Download Part 2: Putting environmental monitoring theory into practice
SmartNote:
The crucial role of environmental monitoring in your contamination control strategy
In our latest SmartNote, we discuss the Contamination Control Strategy (CCS), designed to systematically identify, prevent, and address contamination risks, maintain stringent quality standards, adhere to regulatory requirements, and safeguard patient health. And, the role of environmental monitoring, which is an essential aspect of contamination control and crucial for maintaining product integrity and safeguarding patient safety.
Webinars
Aseptic Process Validation – A risk-based approach
Speaker: Shanshan Liu, Technical Director at No Deviation, has over 15 years of professional experience in the field of quality and compliance, regulatory, process development and engineering, process automation, CQV, and project management of bio/pharm projects.
In this webinar, we will discuss the principles of aseptic process validation based on current regulatory expectations and industry best practices, and evidenced via supporting case studies. Plus, hear more about the risk assessment approach and critical success factors for effective media fill simulations.
Risk-based approach for environmental monitoring
Speaker: Dr. Tim Sandle is a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester, with over thirty years’ experience of microbiological research, quality assurance, and biopharmaceutical processing.
The European Union (EU) GMP and PIC/S Annex 1 requires a contamination control strategy and a risk-based environmental monitoring program is a core part of this. In this webinar the use of quality risk management to understand your process will be discussed covering: identification of hazards, assigning sample types, selecting monitoring locations and establishing sampling plans.
Featured solutions
Putting the media in media fills | |
 | Reduce the burden of aseptic process simulations and safeguard sterility and product safety with high quality Thermo Scientific™ cold filterable media, available in both dehydrated culture media and bioprocess container formats. Learn more |
Confident environmental monitoring with enhanced sustainability | |
 | Our pharmacopoeia-harmonized Thermo Scientific™ Triple Wrap Plates, including both contact and settling plates, are better for your environment, and better for our environment ─ now packaged with zero styrofoam to support your facility's green initiatives. |
For more information on all of our biopharmaceutical manufacturing solutions, and to request a quote or demonstration, visit thermofisher.com/pharmamicrobiology.
Style Sheet for Global Design System
Style Sheet for Komodo Tabs