By Oliver Stauffer
“The syringes market is expected to reach USD 15.99 Billion by 2021 from USD 10.56 Billion in 2016, at a CAGR of 8.7% during the forecast period. High prevalence of chronic diseases across the globe, rising geriatric population, increasing adoption of safety syringes, technological advancements, and increasing demand for vaccines are supporting the growth of this market” (marketsandmarkets.com, 2016).
“Drug manufacturers are required to check and demonstrate the system is capable of maintaining its microbial barrier integrity. In response to the increasing regulatory expectations, the pharmaceutical industry has driven and witnessed significant technical advancements in CCI testing. Instrumentation-based technologies, such as high voltage leak detection (HVLD), vacuum/ pressure decay, mass extraction, and tracer gas detection (helium, oxygen etc.), have emerged and demonstrated improved detection capabilities compared to conventional dye and microbial ingress methods” (Li, 2013).
“The most common inspection technologies use machine vision, the combination of video and computer technologies, to capture and quickly analyze images of product. Today’s automated inspection systems use several cameras to inspect specific regions of a vial or syringe in detail. These inspection stations include specialized lighting to highlight specific types of defects” (Forcinio, 2014)
Plurality of the test methods used in the industry reflects the fact – there is no single “the best” test method, every method available has some advantages and shortcomings depending on production conditions.
With the success of PTI’s MicroCurrent HVLD technology for parenteral products, the next challenge was to implement an inspection method to automate testing pre-filled syringes in a nested tray.