Lighthouse White Papers
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Correlating Laser-Based Headspace Analysis To Helium Leak Rate Testing
5/22/2023
Laser-based headspace analysis is a non-destructive and rapid method for testing container closure integrity. We demonstrate that headspace analysis is equally as sensitive as helium leak rate testing.
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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.
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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.
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Water Activity Measurements And Microbial Contamination In Pharma Products
6/19/2020
Non-sterile pharmaceutical products, including oral solid dosages (OSDs) such as tablets, capsules, and softgels, are subject to microbiological examination prior to release and during stability testing.
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The Impact Of Water Activity On The Chemical and Physical Stability Of Oral Solid Dosage Products
6/18/2020
This paper presents three case studies to show that direct water activity measurements can determine the impact of moisture on potency and dissolution.
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Water Activity Determination Of Oral Solid Dosage Products Using Frequency Modulation Spectroscopy
6/18/2020
Controlling water content in oral solid dosage (OSD) products, and dry pharmaceutical products in general, is essential to maintaining efficacy and safety. Measuring the water activity at multiple time points during the product life-cycle will correlate to changes in critical quality attributes such as degradation of the active ingredient, changes in the dissolution or disintegration rate, and changes in physical properties such as hardness or friability.
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Container Closure Integrity Testing Of Sterile Injectable Product
3/18/2020
This article summarizes the current state of container closure integrity testing in the pharmaceutical and biopharmaceutical industries and outlines possible approaches for developing a CCIT strategy.
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Rapid Nondestructive Moisture Determination Of Freeze-Dried Product
12/28/2018
Rapid water vapor determination with an optical method could replace the slow destructive traditional methods for the moisture analysis of freeze-dried product. A description of industry applications of headspace moisture analysis including freeze drying cycle optimization, lyo chamber moisture distribution mapping, and 100% moisture inspection of commercial freeze-dried product.
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Introduction To Laser-Based Headspace Inspection And The Application To 100% Container Closure Inspection
12/26/2018
Gain insight into the process, ensure the maintenance of sterility for finished product after capping, and meet current regulatory guidance using laser-based headspace inspection.