Equipment and Processing Report
PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the May 2009 edition from Continental Disc and Filimatic.
Continental Disc
Rupture disc withstands severe conditions
Continental Disc (Liberty, MO) has added the MP unit to its SanitRX series of rupture discs. The product was designed for applications during which conditions frequently change between positive pressure and vacuum. The company moved the disc’s score line from the contact side to the downstream side so that it is subject to less stress when pressure changes. The new position also improves the disc’s cleanability. The disc can be cleaned or steamed in place.
The disc complies with the American Society for Mechanical Engineers’s bioprocessing equipment criteria for process-side surface finish and fully traceable metal and elastomer materials. The component also is free of polishing compounds, release agents, and animal derivatives. The disc’s flow-resistance values are 1.13 for gas and 1.60 for liquid. The disc is appropriate for pressure-vessel applications such as autoclaves, fermenters, and heat exchangers.
Filamatic
Adaptive filling machine
Filamatic’s (Baltimore, MD) AdaptaFil semiautomatic filling machine now offers interchangeable peristaltic, gear, lobe, and piston pumps. Pump changeover does not require tools and enables users to adapt the device to run new products. Changeover also reduces operators’ need to learn how to use new equipment, says Jack Chopper, chief electrical engineer for Filamatic.
The unit can operate at production scale and can be incorporated into an automatic filling line. The filler’s human–machine interface allows operators to save and retrieve recipes by name and number, copy recipes to other machines, and change fill setups easily. The machine’s software system provides control over fill speeds and delay time between fill segments. Users can calibrate a fill with the push of a button.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.