PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the January 2011 edition from AdvantaPure and NETZSCH Premier Technologies.
AdvantaPure
Overmolded fittings reduce entrapment
AdvantaPure’s Overmolded Tri-Clamp Ends are suitable for applications such as transferring media, dispensing, and final filling. Because polypropylene fittings are thermally mated to the end of the tubing, the overmolded products provide a completely smooth inner diameter that reduces the opportunity for bacterial entrapment, compared with barb-type fittings. The overmolded fittings also eliminate leakage and minimize the risk of contamination because they do not rely on mechanical connections.
The Overmolded Tri-Clamp fittings are available for various sizes of polyvinyl chloride, thermoplastic elastomer, and thermoplastic rubber tubing. The fittings do not restrict flow or the inner diameter of the tubing. Clients can choose fitting models that are injection molded from US Pharmacopoeia Class VI thermoplastic polyester elastomers or polypropylene. The Tri-Clamp Ends are certified free of animal-derived ingredients and are designed to be cleaned and sterilized easily. In addition, AdvantaPure can provide molded silicone assemblies and various single-use process components.
NETZSCH Premier Technologies
Nanoparticle mills provide efficiency and control
The DeltaVita line of ultrafine nanoparticle mills from NETZSCH Premier Technologies includes devices appropriate for the wet grinding of batch sizes from 0.05 to 2000 L. The mills’ high-energy input and high flow rates in a recirculation process enable them to complete 10 cycles in the time it takes other mills to complete one. Continuous high-flow throughput ensures that the entire batch passes the mill several times before the process is completed while the batch tank is continuously agitated. The milling process is continuously monitored, which helps control the end point of the process and yield the desired product quality.
The DeltaVita mills incorporate NETZSCH’s Zeta grinding system, which uses small grinding media to produce fine end products in the nanometer range. The machines are designed for easy cleaning, repeatability, and easy validation. The units are isolated for operator safety, and their wetted parts are manufactured according to good manufacturing practice standards.
Navigating Annex 1 for Early Phase Sterile Fill Finish in Clinical Supplies
November 21st 2024Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.
Why is the PDA Pharmaceutical Microbiology Conference the Hottest Ticket in the Industry?
October 10th 2024Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.
Ensuring Quality from the Start: Raw Materials Testing Support
November 21st 2024Raw Materials are the foundation of every biopharma product. Our ultimate guide highlights how our testing support can help you establish purity, identity, and quality standards, ensuring a smooth manufacturing process and adherence to regulatory requirements.
Ensure the Safety of Allogeneic Therapies with Advanced qPCR Testing
November 21st 2024Elevate your viral screening with Eurofins BioPharma Product Testing’s qPCR- based assays. Our advanced testing goes beyond standard screenings to detect even dormant and hard-to-detect pathogens, ensuring comprehensive safety in every stage of the allogeneic therapy pipeline. Protect your products – and your patients- with industry-leading sensitivity and specificity.