INSIGHTS ON MANUFACTURING LOGISTICS

  • Digitally Connected, Liquid Nitrogen-Free Cryogenic Cold Chain
    4/12/2021

    A cryogenic cold chain starts with cryopreservation. Achieve consistent results without liquid nitrogen, scale effectively and efficiently, and get traceable digital records.

  • Switch To A Nitrogen-Free Cryopreservation System
    4/5/2021

    This study focuses on the running costs and carbon emissions associated with cryopreservation equipment, comparing a liquid nitrogen (LN2)-free controlled-rate freezer with a typical liquid nitrogen-based system. The environmental implications of using liquid nitrogen for cell freezing are explored along with carbon emissions during the manufacture, transportation, and operation of LN2-free controlled-rate freezers.

  • The Science Of Cell Therapy Thawing
    4/5/2021

    This guide summarizes the science of thawing following conventional, slow freezing methods. We address how cell thawing has historically developed into the techniques used today, along with the physical and biological implications of key metrics and components, such as warming rate and ice structure. Also included are reviews of key studies from scientific literature and a consideration of the interactions between cooling and warming rates, as applicable to cell and gene therapies.

  • Freezing Biologics For Storage And Transport
    3/29/2021

    The process of freezing biologics for storage and transport is expected to play an increasingly important role in optimizing the supply chain as markets and production sites become more diverse. As the chosen freezing method can affect both product quality and amount of product loss, it is important to fully understand this critical step in the process. In this video we discuss an end-to-end solution to fill, freeze, transport and thaw bulk drug substances.

  • Automated Inspection System For CCIT Of Parenteral Drug Products: Veripac LPX
    3/22/2021

    The VeriPac LPX from PTI is the next generation automated inspection system for container closure integrity testing of parenteral products. This product features automated CCI for prefilled syringes and vials using PTI’s vacuum decay technology.  The VeriPac LPX features a dynamic design tailored to fit your production requirements.

MANUFACTURING LOGISTICS SOLUTIONS

  • The VeriPac 465 performs leak detection based on the basic principles of physics and does not require the use of trace gasses or sample preparation to perform the test. The VeriPac 465 core technology is based on the ASTM vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments. The VeriPac 465 combines technological innovation and practical adjustments to patented dual vacuum transducer technology, PERMA-VAC, to make it the most sensitive and versatile vacuum-based leak detection technology to date. Through the introduction of unique test cycles, pneumatic controls and processing algorithms, the VeriPac 465 is establishing itself as the foremost vacuum-based leak test for parenteral products.

  • The VeriPac 465 performs leak detection based on the basic principles of physics and does not require the use of trace gasses or sample preparation to perform the test. The VeriPac 465 core technology is based on the ASTM vacuum decay leak test method (F2338) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using VeriPac leak test instruments.

  • Thermo Scientific™ Nalgene™ Biotainer™ bottles and carboys are specifically designed to ensure the integrity of your valuable contents and meet demanding biotechnology requirements, including prolonged storage of pH-sensitive materials, freezing of contents, and storage and transport of harsher materials.

  • The most current model, the Seal Integrity Monitoring System (SIMS) 1915+, is the ideal choice for your helium-based leak detection system. Compared to conventional vacuum bubble and dye penetration test methods, packages can be quantitatively tested using helium as the tracer gas that ensures higher levels of accuracy. Such an approach allows a comparison between multiple packaging materials and forms production line settings and stability storage conditions, supporting the entire lifecycle.

  • There have been many advances over the past decade in terms of drug product delivery methods. As a result, key developments like unique cartridge based delivery systems have become common. It is well documented that Helium mass spectrometry is most suited for non-porous packaging such as vials and syringes. The same methodology can also be applicable to cartridge based delivery systems. In most cases the key to success is the development of a text fixture device designed and manufactured to the specific cartridge system being testing. These custom fixtures for helium leak detection can be designed to isolate specific areas of interest in the cartridge system.