Inspection Featured Articles

  1. The Impact of Well-Designed Weighing Processes On Product Quality 4/22/2015

    Companies involved in the production of pharmaceutical products are well aware of the importance of consistency and accuracy in manufacturing processes. Batches that fail quality inspections waste time, labor, effort, and resources. This further leads to a loss in profits and market reputation, as well as compromises human health and safety.

  2. Staying On Top Of Microbes: Smarter Testing Technology For Labs Of The Future 4/15/2015

    Over the past decade, drug and medical device manufacturers have become leaner and more stream-lined. Given the current market pressures, companies are looking for more ways to improve their bottom-line.

  3. USP General Chapter <1207> Revisions: Industry Experts Offer Best Practices To Avoid Destructive, Unreliable Integrity Testing 10/1/2014

    The US Pharmacopoeia released a proposed revision to USP General Chapter <1207> Sterile Product Package – Integrity Evaluation for public comment, which focuses on package integrity testing. This chapter is not mandated but does reflect recommended best practices. These changes are necessary to better protect not just the product but also the patient.

  4. Assembling The Package Integrity Profile For Autoinjectors

    Due to their complexity, combination products present unique challenges in implementing a container closure integrity (CCI) testing strategy. Learn about these challenges and how to overcome them.

  5. Ensuring IV Bag Sterility With Container Closure Integrity Testing Systems

    In the event of an IV bag leak, contaminants can adversely affect the solutions within. Learn how the reference standard for CCIT, USP 1207, applies to the CCIT inspection method of IV bags.

  6. Key Considerations For Selecting Flexible Fillers

    Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.

  7. The Importance Of Container Closure Integrity (CCI) Feasibility Testing

    In the CCIT space, one single inspection technology cannot be used for every type of pharmaceutical product. You should always weigh the various factors to determine the ideal inspection methodology.

  8. Single-Use Manufacturing Systems: Implementation Considerations

    As single-use systems continue to evolve, more biopharma companies will be able to benefit from their ever-improving reliability and unique adaptability as part of both fully single-use and hybrid processes. 

  9. Evaluating Container Closure Integrity Of High-Risk Pharmaceuticals

    Manufacturing inconsistencies often result in container closure failure, causing serious implications down the supply chain. Learn why it is critical to use the most precise leak testing method possible.

  10. Selecting Container Closure Components: A Data-Driven Approach To CCI

    Discover an efficient, data-driven process that employs innovative methods to accelerate the selection of a closure containment system that meets the requirements of the modern regulatory landscape.