Automated Inline Solutions
Automated Inline Inspection Technologies for Complete Quality Control
Automated inspection solutions across all PTI technology platforms – Vacuum Decay, Airborne Ultrasound, MicroCurrent HVLD and Force Decay.
Automated Testing to optimize QA/QC
In addition to offline laboratory systems for leak detection and package quality testing, we offer configurations that provide the capability of fully automated inspection. Automated Systems have been designed using PTI’s Vacuum Decay, MicroCurrent HVLD and Airborne Ultrasound and Force Decay technologies for applications that include automated statistical process control (SPC) testing up to fully automated robotic pick and place package handling.
Automated CCI Solutions for Pharmaceutical Packaging
Automation and digital measurement systems have systematically become a greater part of pharmaceutical manufacturing. The ability to capture better quality data and provide a seamless data integrity solution is critical to all applications. Nowhere is this more evident than in the parenteral fill-finish environment. Considering the guidance documentation and vision of different regulatory bodies, focusing on CCI within the fill-finish arena becomes an incredibly effective space to develop a solution to assure CCI with the highest level of reliability in an automated fashion. Either of PTI’s parenteral CCI solutions (HVLDmcor Vacuum Decay) can effectively be deployed for the wide range of parenteral package formats and application requirements in a robotic automated platform. Between the two technologies, 95% of parenteral applications can be tested for CCI down to critical to quality leak sizes.
Prefilled syringes and single use injection devices are the future of pharmaceutical delivery systems. As the industry develops unique delivery solutions, greater understanding and control of primary container quality is needed. Shifting strategies within the pharmaceutical industry around container closure integrity (CCI) are driving towards a more robust data driven environment. Deterministic technologies that provide a more reliable test measurement can be leveraged to automated inspection platforms. Challenges that face the prefilled syringe call for deploying alternative technologies and inspection methods. Automatic inspection systems that provide answers to the dynamic challenges introduced by prefilled syringes creates a level of assurance required for such high-risk applications.
PTI’s robotic automated inspection platform provides best in class CCI testing with no compromise within the parenteral process. PTI’s technologies provide the reliability and accuracy in test measurement, while the automation platform provides the flexibility needed to not compromise on quality. HVLDmc and Vacuum Decay overlap in capabilities, but more importantly encompass the full parenteral market range. Both technologies are validated as non-destructive methods with leak detection sensitivity down to critical parenteral leak sizes. The technologies are specifically referenced in USP’s Chapter 1207 and have been the subject of depth of scientific research supporting the effectiveness of the measurement solutions. A robust inspection solution to meet the needs of the biologics industry is simply a matter of automating and scaling the functions typically performed by an operator in an offline setting.
Automated Pouch Seal Inspection
The VeriPac LPX for flexible packaging enables continuous testing and throughput of pouches, stick packs, sachets and other flexible packaging formats.
Automated Testing Benefits:
- Increased sampling rate
- Automated data processing
- Eliminates live intervention
A high-speed robotic gripper arm will pick & place the packages into the VeriPac LPX test chambers
where a rapid vacuum-based test is performed. A definitive PASS/FAIL result is displayed along with
quantitative test result data. The packages will then be reintroduced to the product line to ensure
continuous flow and seamless downstream handling. Rejects are automatically removed from the
VeriPac LPX Benefits
- Automated testing enables the highest level of container quality assurance
- Deterministic, quantitative test method
- ASTM Test Method F2338 and FDA standard, ISO 11607
- Distinct PASS/FAIL results
- Highly accurate test results - low false positives and false negatives
- High Signal Noise Ratio (SNR) for peak sensitivity and reliability
- Non-destructive, non-subjective, no sample preparation
- Pick-and-Place option back into the production line
- Auto reject option of defects removed from the production line
- USP <1207> compliant
Automated 100% Pouch Seal Quality Inspection
Seal-Sensor Technology Integration
PTI works closely with industry leaders to integrate PTI’s inspection and sensory technologies into their equipment for automated process and quality control on the production line.
PTI’s Airborne Ultrasound Technology for the 100% Inline inspection of pouch seals has been a successful global solution to verify final pouch seal quality. Seal-Sensor scans seals for defects as the pouch seal passes through the Seal-Sensor test head on the production line. Seal-Sensor can detect common seal defects such as voids and delaminations, foreign materials and inclusions, incomplete seals and misaligned seals. Seal-Sensor detects seal defects and automatically rejects defective pouches from the production line. Package materials & combinations include Tyvek®, paper, foil, film, aluminum, plastic and laminated materials.
Automated Inline Inspection of Low-Head Space Packaging
The VeriPac 410 force decay technology for non-destructive seal and leak detection for blister packs, sachets, and pouches with low headspace has been successfully integrated for automated online inspection.
The VeriPac 410 inspection technology platform combines the sensitivity and reliability of PTI’s vacuum decay technology while introducing a force-based measurement to enhance results. The 410’s force decay technology is capable of measuring force from the surface deflection of a package during a normal vacuum based test cycle. This force measurement of the package surface allows the VeriPac 410 to identify which package is defective while also being able to leak test packages with minimal headspace, such as surgical suture packaging, achieving target leak size detection below 20 microns.