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.
E-SCAN 665 ROBOTIC TEST SYSTEM
The E-Scan 665 is a fully automated robotic inspection system for container closure integrity testing of nested pre-filled syringes. A single, high speed compact 6-axis robotic arm picks & places rows of syringes from the nested trays into the HVLDmc test position.
The robot picks 10 syringes from a row, and the HVLDmc testing probes automatically scan each syringe in continuous motion. The robotic system provides all the necessary handling:
Test results presented to the operator include a definitive pass/fail on test completion along with quantitative test result data. This automated HVLDmc technology is suitable for low speed production lines, “production lot on hold” 100% inspections, as well as high sampling rate SPC inspection on high speed production lines. Current destructive test methods required that whole batches must be scrapped in the event of a leak being detected. The E-Scan 665 can process a batch worth over $1 million in a matter of hours, making it a great tool to process suspect product at a reasonable speed and price. It takes just a singular quality deviation to provide the ROI for an E-Scan 665.
The nature of PTI’s MicroCurrent HVLD allows the E-Scan 665 to inspect a wide range of product classes and delivery systems. The technology provides reliable inspection and detection of leak sizes down to the critical to quality levels. Traditional HVLD systems may struggle to inspect low conductivity liquids or smaller diameter container formats. PTI’s E-Scan 665 can perform a CCI inspection on syringes containing Water for Injection (WFI) on small diameter formats such as a 1mL syringe. The E-Scan 665 delivers advanced automated CCI inspection to meet the guidelines of USP 1207 and ANNEX 1.