Application Notes & Case Studies

  1. Meeting GMP Requirements For Closed Handling Of Vial Stopper Components In Filling Operations

    In 2011 the State Food and Drug Administration of China (SFDA) published a revised version of the GMP regulation. Hence, all new and upgraded manufacturing facilities will need to comply with these requirements with strict deadlines for existing manufacturers of sterile products.

  2. A Remedy For Humans, A Challenge For Pharmaceutical Packaging Technology

    With demands for their cough syrup is increasing, a company decided to install an additional production line for the safe filling and packaging of cough syrup into glass bottles. With the help of equipment expert Bosch Packaging Technology, they realized a compact turnkey solution with high throughput.

  3. A Case Study In Real-Time Release Testing

    Real-time release testing can be defined as a set of in-process controls that may provide greater assurance of product quality than end-product testing.

  4. Medical Device Manufacturer Improves Product Quality Control

    A platform’s integrated business framework helps dental implant and medical device manufacturer eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.

  5. Data Solutions For CMOs Working With Sponsor Organizations

    CMOs can empower their sponsors or customers to conduct many of these activities on their own products or processes through better data transparency.

  6. Ensuring Pharmaceutical Film Strength To Avoid Damaged Product

    This method can be used to identify potential points of weakness in a film or seal during the manufacturing process by simulating circumstances whereby the material may burst during packaging and transport.

  7. Evaluating Inhaler Performance To Ensure Clinical Efficacy

    MDIs are designed to deliver precise/accurate and reproducible doses of the drug to the lungs or nose. Good performance is crucial as patients rely on their inhaler to deliver the required dose of medication at often crucial times.

  8. Measuring The Hardness Of Blister Packs To Determine Effectiveness

    The degree of stiffness of a blister pack will affect its effectiveness. Measuring the required force to push-through a blister pack is therefore necessary.

  9. Temperature And Humidity Measurement For Cleanrooms

    With the importance of monitoring and verifying pressure conditions as well as humidity and temperature measurement data in its cleanrooms, this automation, management and monitoring solution offered a consistent solution for technical facility management and thus the prerequisite for cost-optimized plant operation.

  10. Fighting The Opioid Epidemic: How Grünenthal’s Abuse-Deterrent Technology Contributes

    While the wider use of opioids has led to many benefits for patients in pain, it also has led to higher incidences of misuse, abuse, and development of opioid addiction. To address this issue without preventing legitimate patients from receiving their necessary medication, Grünenthal set out to create an abuse-deterrent formulation with a technology that creates a physico-chemical barrier to abuse and, as a result, safeguards patients from the battle of addiction.