Cleanliness and Microbial Integrity using the NovaSeal™ Crimping Tool during Sterile Sampling of Bioprocess Products
Thursday, May 14, 2015
2:00pm - 3:00pm EDT
Speaker: Corinne Miller, R&D Manager, Virology & Microbiological Sciences
The NovaSeptum® single-use sterile sampling system offers improved, contamination-free sampling of bioprocess products and intermediates compared to traditional sampling methods. A critical step in any sampling step is disconnection of the sampling container from the process container. When it comes to biopharmaceuticals, separation and isolation of compartments, including vessels, containers, or single-use assemblies, can be a cause of contamination. For the manual NovaSeptum® sampling system, the NovaSeal™ crimping tool crimps and cuts a metallic pinch-pipe on the exterior of sample tubing to provide sterile disconnection of the sample container.
In this study, the manual NovaSeal™ crimping tool has been evaluated for cleanliness and integrity of the tubing crimp to both bacterial and viral passage. Crimp cleanliness and integrity to virus outgress has been demonstrated for both silicone and thermoplastic elastomer (TPE) tubing. The NovaSeal™ crimping tool is ideally suited for sterile product sampling, including for viral vaccine production applications, ensuring cleanliness and integrity of the sampling crimp, lack of operator exposure, and protecting the product during bioprocess sampling and handling.
Webinar Learning Objectives:
- Crimp cleanliness eliminates operator exposure risk
- NovaSeal™ crimping tool ensures sample integrity
- Contamination-free sampling of bioprocess products and intermediates
Listen to recordings of past webinars from INTERPHEX's 2013-2014 Webinar Series. The Webinar Series aims to support INTERPHEX's robust conference program and will serve as the industry's year round education resource, covering the hottest topics and trends.
When CIP Spray Systems are not Recommended or Unavailable: Then What? A Scientific Perspective
Speaker: Jeff Phillips, Director, Science and Marketing, Alconox, Inc.
This webinar will cover general chemistry of aqueous cleaning with a focus on the use of high foaming detergents or non-spray ball CIP cleaning. Also covered will be the 9 variables in effective cleaning. This will cover things such as how a surface is treated before it’s cleaned through how these surfaces are stored when cleaning has been completed and everything in between. A focus will be paid on the often forgotten examples when more powerful emulsifying detergent use may be necessary or preferable compared to those detergents with little or no emulsifying capability. By attending this webinar you will understand the chemistry of aqueous cleaning, understand the variables and how to utilize them to achieve optimal cleaning, and when to use manual and/or high foaming detergents for cleaning pharmaceutical manufacturing equipment.
Performance and Fluid Contact Extractables Evaluation of Polyethylene Films
Speaker: Karen Green, Senior Product Manager, Mobius® Single-use Assemblies
Biopharmaceutical companies are using single-use containers and assemblies for upstream and downstream processes at an ever increasing rate. Since process fluids come in contact with the inner film layer of these single-use containers, there is a need to understand the extractables profile at room and elevated temperatures and over prolonged time of exposure. This webinar will outline the study that determined the extractables profile of our new PureFlex™ Plus film and original PureFlex™ film. By attending this event, you will learn about the model stream approach used in the study and why we chose this approach instead of conducting actual formulations. We will present out the results of the extractables profile for the new PureFlex™ Plus film and answer any questions you may have about extractables and leachables as they relate to single-use technologies.
Taking Life Sciences to the Cloud
Speakers: John Niziolek, Practice Leader, Compliance, Cornerstone OnDemand and Aaron Weinstein, Senior Director - Validation Services, IPS - Integrated Project Services
Life science organizations face unprecedented compliance and transparency expectations today. In order to meet requirements, focusing on the development of your people has to be just as important as your improving upon your product. But is there a way to continually develop your staff to meet new requirements without it interfering with your core business?
Performance and Economics Analysis of Fully Automated Single-use Tangential Flow Filtration Process
Speaker: Engin Ayturk, Ph.D., BioPharm Applications R&D, PALL Corporation
Fully automated design approach to single-use tangential flow filtration (SUTFF) brings real-time process control, monitoring, flexibility and reliability in manufacture. Gamma irradiated Cadence™ Single-use TFF modules are scalable and easy to use, and form part of the fully automated UF/DF solution from Pall Life Sciences. This approach is well suited for R&D, clinical manufacturing or commercial production up to several hundreds of liters. The system can be implemented in multi-purpose or multi-product facilities, or CMOs (flexible facilities), for applications with containment or safety issues and processes targeting increased productivity. In addition to the application data showcasing SUTFF module performance, a detailed process economics modeling analysis will compare single-use versus conventional stainless steel TFF technologies and quantify the impact of key process parameters. In this context, the modeling strategy and the key points of SUTFF process economics will be presented via sensitivity and benchmark analyses under the main cost of goods categories of capital, materials, consumables, labor and facility operating costs.
Single Pass Tangential Flow Filtration for Bioprocessing
Speaker: Joseph Parrella, Biomanufacturing Engineer, Biomanufacturing Sciences Network, EMD Millipore
Downstream purification processes for biopharmaceutical products are being challenged by increasing bioreactor titers as well as demand for higher concentration final formulations. In some cases, these challenges may result in a reduction in facility run rate or process yield. Single pass tangential flow filtration (SPTFF) provides a simple and effective solution to overcome these challenges without requiring major changes to facilities or purification processes. This webinar reviews the advantages of SPTFF, discusses applications where SPTFF adds value, provides recommendations for process development, and presents guidance for scale up and implementation.
Going Beyond The Batch: Benefitting From Continuous Thermal Viral Inactivation & Sterilization
When used for viral inactivation, sterilization, or pasteurization of liquid biologicals such as media, pharmaceuticals, and nutraceuticals, Continuous Flow Thermal (CFT) Processing offers many crucial advantages over traditional processing.
Optimizing a Continuous Wet Granulation Process by Understanding Granule Properties
In developing a continuous wet granulation process, it is easy to produce a large number of samples by varying both the formulation as well as the process parameters. Commonly used granule measurements include loss-on drying of residual moisture content, and particle size measurements from which correlations including the Carr Index and Hausner ration may be calculated. However, it is seen that these measurements are not sufficient to differentiate between a large number of samples produced at conditions which are not drastically different. Using a powder rheometer, we have been able to repeatably measure and produce reliable trends at multiple points in the process train (powder feeders, wet granules, dry granules) to determine which powder properties are critical-to-quality in generating the desired tablet properties. In this study two formulations were studied to demonstrate how to use improved understanding of granule properties to develop the design space of a continuous manufacturing process.
Emerging Market Capital Sourcing
Speaker: Kevin Batche, Sr. Procurement Manager, IPS – Integrated Project Services
Evaluated from an operations standpoint rather than a technical standpoint, this webinar looks at common fears as they relate to sourcing process and packaging equipment from emerging markets. Of primary concern are the risks associated with material segregation, cross-contamination, test reports, qualification documentation, as well as parts and service after start-up.