INSIGHTS ON PHARMACEUTICAL INSPECTION

• How To Ensure Container Closure Integrity Of Combination Drug Products

  The rapidly increasing preference towards combination pharmaceutical products continues to fuel innovation, while presenting unique challenges in implementing a container closure integrity (CCI) testing strategy. Common examples of combination products include prefilled syringes, pen injectors, inhalers, and drug-eluting stents, orthopedic products, infusion pumps and more. The packaging for combination products can be just as complex as the products themselves. Hence, container closure integrity testing in line with current USP <1207> guidance and regulation is critical to ensure package integrity.

• Applications For High Voltage Leak Detection You Might Not Be Aware Of

  High Voltage Leak Detection (HVLD), a technology first applied to pharmaceutical manufacturing in the 1970s, does not destructive to packaging components or cause the loss of good product like other inspection methods. HVLD is capable of handling any product as long as  the container is made of electrically insulated material and the product contains an electrically conductive solution. In this article you will learn more about other packaging applications that can be inspected with HVLD.

• Six Mistakes Pharmaceutical Companies Make When Implementing Serialization

  This article examines mistakes that are commonly made in the planning and implementation phases of a serialization project, and proposes a solution to avoid each of these issues.

• Evaluating Container Closure Integrity Of High-Risk Pharmaceuticals

  Since many high-risk pharmaceutical products are filled and sealed in combination devices, it’s critical for manufacturers to ensure that the components function well together. Hence, design and distribution considerations are critical to both the drug and the container. Manufacturing inconsistencies and tolerance differences in packages containing multiple components are primary contributors to distribution issues. Often, such inconsistencies result in container closure failure, causing serious implications down the supply chain. It is critical to use the most precise leak testing method possible.

• Protecting Oxygen Sensitive Formulations Throughout Product Life Cycle

  5/19/2021

  The headspace gas composition in parenteral product containers is critical for sterile oxygen-sensitive drug product. This webinar reviews how oxygen levels in finished parenteral drug containers can be determined and controlled throughout the product life cycle by using laser-based headspace analysis. From development to manufacturing and QC, the optimization and control of oxygen levels can play an important role in achieving optimal shelf life and protecting drug efficacy.

• Gene Therapy: Maintaining Sterility At Low Temperature Storage

  6/23/2020

  Bringing the first gene therapy for pediatric Spinal Muscular Atrophy to market in a leak and break resistant container which maintains sterility over product shelf life, through freeze and defrost cycles presented challenges. A combination of high-quality components created a proven system which ensured CCI over the product shelf life and low temperatures.

• A Holistic Strategy To Ensure Container Closure Integrity Of Sterile Injectable Vial Product

  1/25/2021

  Recent regulatory guidance has triggered changes in industry best practices in the area of container closure integrity testing (CCIT). However, assuring good CCI of sterile injectable product goes beyond CCI testing. A more science-based holistic approach that includes robust design & qualification of the process and the implementation of appropriate process controls is required. This article describes a framework enabling such a holistic approach to CCI that assures both the primary packaging and the process contribute to good CCI of sterile injectable vial product.

• Experimental Design And Statistical Tools For Non-Destructive Package Integrity Testing Systems

  3/26/2020

  This short podcast focuses on experimental design and statistical tools we use with non-destructive package integrity test systems. PTI’s Veripac inspection systems are deterministic test methods for package integrity testing that produce reliable and robust quantitative test data.

• Package Inspection Guidelines For Sterile Medical Products

  4/9/2020

  Class III medical devices have a unique set of requirements and package characteristics that need a comprehensive approach to selecting the right inspection methods. A variety of inspection methods exist for medical package inspection that require a thorough understanding to ensure quality.