Webcasts On-Demand


Extractables & Leachables in Single-Use Systems	The webinar examines the key topics concerning the use of polymeric single-use products in biopharm processes. DOWNLOAD SLIDES	TO WATCH PART I TO WATCH PART II (continued)

Improving Clinical Trial Outcomes by Proper Selection of Drug Delivery Systems	The live Webcast will address the reconstitution and delivery of lyophilized drugs and how they can be prone to errors that impact the safety and efficacy of drug treatment. Errors during reconstitution can lead to under or over dosing, thus effecting clinical trial outcomes and patient benefit. Drug manufacturers have the choice of lyophilizing their drug in a vial or a pre-filled syringe and using reconstitution systems to enhance accuracy and precision of drug delivery. This study investigates the effect of three different reconstitution methods on the accuracy and precision of a 1 ml delivered dose.	TO WATCH

Fundamentals of Lyophilization in Syringes	The webinar will provide an understanding of the basic fundamental principles in the syringe lyophilization process. It will include an overview of the lyophilization in syringe vs. vial, and will discuss challenges involved in freeze-dried products in syringes.	TO WATCH Reconstitution Device: DuoJect's SmartRod Plus

Setting Optimal Microfluidizer Process Parameters to Control Particle Size Reduction	Particle size reduction by microfluidization is achieved when particles are forced through a small dimensional-fixed orifice at high pressures. Numerous collisions occur, large amount of shear and heat are generated. The final outcome is dictated by many variables. Regardless of whether the product is crystalline or polymeric, these variables can be controlled and manipulated to produce outcomes that are desirable not only from the perspective of analytical measurements, but for manufacturing and operations.	TO WATCH Part I-Microfluidics Part II - Hyaluron

Comparison of CCI of Syringes and Vials during Transport	What is a better container: syringe or vial? Understand more about the container closure integrity of syringes/vials during the transport and the possible outcomes. It has been shown that during air transport of pre-filled syringes, the stoppers are prone to move in response to changes in ambient pressure. This puts in question the container closure integrity of syringes exposed to reduced pressure. A syringe stopper may move back under reduced pressure and possibly pull contaminants back into the product as the stopper returns to its original position when the reduced pressure is removed. This phenomenon is not observed with vials since the stopper is held in place. This might suggest that a vial is a more rugged container under reduced pressure than a syringe. In this study we demonstrate that with appropriate control over the gas headspace in a syringe the stopper movement can be reduced to negligible. Further we show that if a true CCI failure exists a syringe is a better container to prevent contamination than is a vial.	TO WATCH Q&A

Overcoming Risks of Technology Transfer	Learn how to best conduct a technology transfer of your drug or device manufacturing needs, resulting in a successful production. Due to the GMP environment, technology transfer of a pharmaceutical process is often viewed as a rigid process to be followed. In actuality, the primary requirement of a successful technology transfer is flexibility on the part of both the client and the CMO. That flexibility allows the technology transfer to be executed for what it really is: A risk management and risk analysis exercise geared toward the successful production of in-specification clinical material.	TO WATCH Q&A

Recent Webcasts On-Demand

Thank you for your interest in one of our Webinars. If you would like to receive a copy of the slides please contact Nonna Druker at ndruker@hyaluron.com.

If you have any questions or problems please contact ndruker@hyaluron.com.

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