Package Inspection White Papers & Case Studies

31. Considerations In Formulation Development Of Injectable Solutions 2/8/2022

    Injectable solutions offer an alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability, and suitability of administration under hospital setting.

32. Digital Transformation In Regulatory: Achieving Excellence Virtually 1/24/2022

    As the industry looks forward, key decisionmakers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually.

33. Headspace Moisture Analysis For Determination Of Residual Moisture Content In Lyophilized Pharmaceutical Products 8/24/2021

    Here, we describe how rapid non-destructive headspace moisture determination enables the generation of insightful data for product life cycle activities.

34. How To Build A Robust Packaging Strategy For Rapid Commercialization 8/3/2021

    Look at the elements involved in building a robust packaging strategy and the key technical considerations in packaging design and operational planning for products of various sizes.

35. Nitrogen Purging Process Development For Oxygen Sensitive Formulations In Pre-Filled Syringes 6/22/2021

    A new biological product, in pre-filled glass syringes, had demonstrated oxygen sensitivity in stability studies. Therefore, the headspace was purged with nitrogen during filling, and the client wanted to validate the batch production process and assess the nitrogen purge efficiency. In this study we demonstrate by performing a 100% inspection on the engineering batches using non-destructive headspace oxygen analysis you could gather the data needed before a commercial launch.

36. An Introduction To High Voltage Leak Detection (HVLD) Technology 4/8/2021

    A majority of methods used to detect pinholes, cracks, and defective seals in containers are destructive. Learn about High Voltage Leak Detection (HVLD) and why it is free from these shortcomings.

37. Test Method Development For A Container Closure Integrity Test Using Headspace Gas Ingress 3/11/2021

    To ensure patient safety, good container closure integrity (CCI) is of great importance for all sterile injectable products. Recent regulatory guidance has made clear that there is no ‘gold standard’ for CCI testing. As a CCI test method, headspace analysis is based on detecting changes in the headspace gas composition that result from gas ingress through a leak. Non-destructive headspace analysis, using laser-based spectroscopy, can be used to directly quantify the gas concentration inside a sealed parenteral package. It can be applied to a range of product configurations, and formulations, and has historically been used for detecting leak defects in modified headspace product.

38. Oxygen Sensitive Product: Comparing Oxygen Testing Methods 3/7/2021

    The accurate determination of oxygen concentration as a critical quality parameter for oxygen-sensitive products is important across the product life cycle activities. Traditional methods for determining headspace oxygen levels in parenteral containers, such as electrochemical methods or gas chromatography, are slow and destructive. This article describes several case studies comparing non-destructive laser-based oxygen headspace analysis with electrochemical oxygen analysis and gas chromatography.

39. Ensuring CCI For Products Requiring Deep Cold Storage By Correlating Seal Quality To CCI 3/3/2021

    This case study describes how packaging development and process study data of a pharmaceutical vial product requiring deep cold storage can be combined in a holistic approach.

40. 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.