Package Inspection White Papers & Case Studies
-
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.
-
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.
-
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.
-
Checkweigher Provides High-Throughput Tube Line Automation Inspection
6/15/2020
Teligent produces a range of generic prescription topical and injectable pharmaceuticals. To automate inspection on their high-throughput tube line, they turned to a dual-lane checkweigher.
-
Inline Weighing Technology Offers Additional Quality Check Features
6/10/2020
Alongside weight monitoring, the checkweigher used at Protina Pharmazeutische GmbH offers other important functions that support the company's system of strict quality management.
-
Utilizing A Checkweigher To Identify Inaccurately Filled Products
6/9/2020
Sanofi-Aventis uses checkweighers to check vital insulin: in the Injectables Division, where liquid drugs such as different types of insulin or drugs for emergency medicine are produced, the packaged medical compounds are subjected to final checks using a dynamic checkweigher.
-
The Importance Of Package Integrity To Shelf Life Of Products
6/9/2020
Pharma Tech Industries, a contract manufacturer and packer of pharmaceuticals and medical devices relies on x-ray, metal detection systems, and checkweighers to achieve their high quality standards
-
OEE And Product Inspection Efficiency In The Pharmaceutical Industry
6/4/2020
Few industries are as heavily regulated as the pharmaceutical industry, as poor quality or otherwise defective pharmaceutical products can potentially have fatal results for end users. Manufacturers must perform a careful balancing act: weighing pressure to improve production speeds against the need to ensure compliance with government regulations. The purpose of this white paper is to provide an overview of the various components that go into measuring OEE, a method of obtaining a complete view of the efficiency of a production process, and then to discuss the ways in which product inspection equipment can affect OEE in the pharmaceutical industry.
-
Contract Pharmacal Corporation Installs X-Ray Inspection And Checkweighers For Brand Protection And Quality
5/12/2020
CPC has five lines of packaging products in a foil-laminated film, which disrupts traditional metal detector, they need to implement x-ray systems for those lines.
-
Experimental Design And Positive Controls For Package Integrity
4/9/2020
Given that the experimental design has only two conditions, leaking and non-leaking, this variable is extremely important to understand. Proper use of positive controls and knowledge of how alternative approaches are applied to challenge a test method support the validity and reliability of the method.