Sampling Videos & On-Demand Webinars

Oct. | 2016

• Presenters:
  
  • Janmeet Anant, Regulatory Advocate, Merck
  • Marc-Antoine Kaag, Global Product Manager, Sampling, Merck
• Abstract

  Increasing validation requirements along with the raise of QbD and PAT have put sterile processes sampling under scrutiny by regulation bodies. Traditional sampling methods have reached their limits whilst closed sampling methods come of age.
  
  Beyond the necessity to ensure contamination control, the regulatory authorities require compliances in different aspects related to the sampling method of a drug. This webinar will review the benefits attained from implementing single-use systems. In this objective, these authorities provide guidance on processes helping to reach these requirements (e.g. QbD, PAT, Process validation). Drug manufacturers have the possibility to respond to these expectations through the implementation of single-use systems, instead of common traditional sampling methods, which include usage of glass bottles or SIP stainless steel valves.
  
  Join this webinar to learn more about the recommendations and requirements stated by these major regulatory authorities around the monitoring of the manufacturing process with the execution of sampling. In addition, this webinar will include a review on the benefits attained from implementing single-use systems, therefore reducing the sampling risks compared to traditional methods.

  In this webinar you will learn:

  • Key drivers for Aseptic Process Sampling
  • Complexity and Risks of "Traditional" Sampling Methods
  • Regulatory Recommendations, Corresponding Needs, and how to get there

May | 2015

• Presenter: Corinne Miller, R&D Manager, Virology & Microbiological Sciences, Merck
• Abstract

  When it comes to biopharmaceuticals, a critical step in any sampling is disconnection of the sampling container from the process container. Separation and isolation of compartments, including vessels, containers, or single-use assemblies, can be a cause of contamination. During this webinar, we will present results of a NovaSeal™ crimping tool study where the cleanliness and integrity of the tubing crimp to both bacterial and viral passage have been evaluated. Crimp cleanliness and integrity to virus outgress has been demonstrated for both silicone and thermoplastic elastomer (TPE) tubing.

Feb. | 2014

• Presenters: Simone Biel, Ph.D., Field Marketing Specialist, Sterile Sampling, Merck and Shawn Bates, Field Marketing Specialist, Single-use Sampling, Merck
• Abstract

  Collecting the right sample at the right place and time is paramount to deliver effective process management in today’s biopharmaceutical manufacturing. Sampling has been shown to be challenging and critical in the production of biopharmaceuticals, vaccines and non filterable drugs. The growing need to improve the effectiveness and minimize risks (PAT, QdD…) has brought more focus on the value to implement sampling plans designed to deliver increased accuracy. The introduction of closed disposable sampling systems opened new possibilities in particular when used in stainless steel processes. Please join us to learn best practices and key considerations for optimizing your sampling plan resulting in enhanced process management. You will hear about current and future regulatory requirements, risk management considerations and best sampling options for bringing your QbD process to the next level.