Package Inspection Featured Articles

  1. Intro To ASTM E3263-20: Qualification Of Visual Inspection For Residues 1/8/2021

    The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.

  2. Six Serialization Mistakes Pharmaceutical Companies Make 12/21/2020

    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.

  3. Implementing Improved Analytical Methods To Support Vaccine Quality 12/18/2020

    Some of the new COVID-19-targeted vaccines are spurring the use of novel analytical technologies to support rapid and thorough characterization, which may help pave the way for other vaccine manufacturers to implement these technologies as well.

  4. Microorganism Challenges On Online Water Bioburden Analyzers: Pitfalls & Best Practices 3/2/2020

    This the second article in a two-part series on conducting microorganism challenge studies using online water bioburden analyzers (OWBAs) in a laboratory setting. Part 1 discussed two different experimental approaches that have been successfully used for microorganism challenges. This second article explores the six pitfalls to avoid and four best practices to follow during execution of microorganism challenge tests.

  5. Experimental Methods For Microorganism Challenges On OWBA 2/17/2020

    While implementing online water bioburden analyzer (OWBA) technology might seem straightforward, several aspects of preparing microbial challenges can easily derail the best intended experimental design.

  6. USP <1207> Updates Leak Testing Recommendations For Pharma Companies 10/2/2018

    Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.

  7. How To Monitor The Performance Of Metered Dose Inhalers (MDIs) 10/21/2015

    The use of metered-dose inhalers (MDIs) for the treatment of diseases such as asthma has become popular since their introduction in the late 1950s. MDIs come in the form of nasal or oral inhalers and are much appreciated by patients who depend on them for their treatment. MDIs are designed to deliver precise/accurate and reproducible doses of the drug to the lungs or nose. This is crucial as patients rely on their inhaler to deliver the required medication at often crucial times when physical strength may be very low.

  8. 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.

  9. 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.

  10. 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.