Manufacturing Logistics Solutions

1. Considerations For Helium Leak Testing 4/30/2021

   Helium leak detection (HeLD) is routinely used and widely accepted for applications that require the utmost leak sensitivity. This brochure explains how Helium enables the discovery of extremely small microleaks that other leak testing methods cannot detect and what applications it can be used for.

2. Next-Generation Labtainer BPC Providing Improved Performance, Reliability, And Higher Quality Assurance 4/22/2021

   As technology and innovation advances within the bioproduction industry, single-use technologies (SUTs) have also made considerable progress in the drug and vaccine manufacturing space. The innovative design of the Thermo Scientific™ Labtainer™ Pro BioProcess Container (BPC) provides improved flexibility and assurance—without compromise.

3. Best-In-Class Formulations, Significant Competitive Advantages 4/21/2021

   The Alliance of Rentschler Biopharma and Leukocare offers contract development and manufacturing with proven excellence including best-in-class formulation that enables clients to realize the full medical and commercial potential of their products. Advanced formulation development is considered at every step of the manufacturing process to capitalize on the full product potential.

4. Sub-Micron Leak Detection For CCIT On Parenterals And Rigid Containers: VeriPac 465 3/5/2021

   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.

5. VeriPac 465 Micro Leak Test System Brochure 3/5/2021

   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.

6. Nalgene Biotainer Bottles And Carboys 3/2/2021

   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.

7. Seal Integrity Monitoring System (SIMS) 1915+ (Helium Leak Detection) 1/29/2021

   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.

8. Helium Leak Detection For Combination Drug Products 1/29/2021

   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.

9. Helium Leak Testing System For Foil Pouches 1/29/2021

   Integrity testing of foil pouches offers a unique set of challenges. In most packaging processes that involve foil as the product barrier there is a concern about the incidence of punctures in the foil. These defects (typically called micro-voids) can be created as the foil is being rolled in thin sheets and tiny particles are inadvertently rolled into the foil. The most common defect is caused from the handling of the packages during the assembly of the foil and insertion of the drug product.

10. Helium Leak Detection For Blister Packaging 1/29/2021

    A helium based test method for verifying the integrity of a blister card holding drug product has been proven to be the most effective approach due to the extreme sensitivity offered. The test method relies on detecting helium sealed in the package system as it escapes through micro-channels in the package. A test sequence begins by placing the package in the test fixture and a vacuum is quickly drawn. The resulting pressure differential causes helium to escape through potential holes or cracks in the package.