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.
This guide explains the concept of metal detector sensitivity, key factors that impact it, and why a small difference in spherical sensitivity performance can mean a big difference in contaminants detected.
This white paper provides an explanation of the differences between validation, verification and routine performance monitoring as well as an overview of recommended test methods for different types of metal detection systems.
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.
A vaccine-focused biotechnology company approached LIGHTHOUSE to help investigate a phenomenon observed in liquid vaccine product stored at -80°C. During QC testing, a number of vials were found to have an overpressure. This phenomenon represented a serious safety risk and LIGHTHOUSE was asked to support an investigation to identify the root cause.
Laser-based headspace provides yet another alternative approach for detecting microbial contamination in sterile pharmaceutical product allows for quicker, more sensitive, accurate, and reproducible test results when compared with conventional, growth-based methods.
This application note describes how laser-based headspace analysis is used for the rapid non-destructive determination of headspace oxygen levels in pre-filled syringes. Data is presented demonstrating two major applications of this technique: 1) headspace oxygen monitoring on a pre-filled syringe line filling oxygen-sensitive product, and 2) container closure testing of pre-filled syringes.
PTI Inspection Systems announces its latest industry driven technological development to advance the capabilities of package testing.
PTI recently formally announced the approval of ASTM Test Method F3004-13, a new non-destructive test method for “Evaluation of Seal Quality & Integrity using Airborne Ultrasound Technology.” Approval of this test method was based on PTI sponsored inter-laboratory research study utilizing PTI’s patented Seal-Scan technology.
PTI will exhibit VeriPac Package Integrity/Leak Detection Systems at Interphex, April 23-25, 2013 at the Jacob Javits Convention Center in New York, NY in Booth 2558.
PTI Inspection Systems will showcase the E-Scan 625 HVLD Micro Leak Detection System at the Interphex Show, April 23-25, 2013 at the Jacob Javits Convention Center in New York, NY in Booth 2558.
Nikka Densok USA will exhibit at the Interphex Show, April 23-25, 2013 at the Jacob Javits Convention Center in New York, NY in Booth 2558.
An overview of color inspection software that will analyze color changes digitally and verify color accuracy before and during printing.
Seidenader's V90 Semi-Automatic Inspection offers the highest qualiity of parenteral product inspection, coupled with the versatility of human intervention.
It is important that each link in the tracking chain speaks the same language, regardless of whether it is hardware, such as labelling devices and inspection systems, or software, such as those used for production line management.
The VeriPac UBV utilizes volumetric imaging under vacuum to detect the presence of leaks. It’s a simple, rapid 3-step process to test a blister pack.
Non-destructive package integrity testing and leak detection of dry-filled flexible packaging, pouches, stick packs and sachets. More efficient and cost effective than destructive test methods. Non-destructive, non-subjective results, no sample preparation, zero waste. PTI’s vacuum decay leak testing technology (ASTM F2338). Test multiple packages in a single test cycle. Rapid pass/fail results and quantitative test data.