Automated CCI for Parenterals

E-Scan MicroCurrent RTX Automated CCI for Pre-filled Syringes

Features Dynamic Robotic design tailored to fit your production requirements.

The E-Scan RTX is a non-destructive, automated package leak testing system for pre-filled syringes. Utilizing PTI’s MicroCurrent HVLD technology, this automated solution is effective across all parenteral products. This technology is listed in the USP < 1207 > guideline as a recommended method for liquid-filled parenteral package inspection. The E-Scan RTX is a scalable, modular solution designed to meet all production requirements.

PTI’s MicroCurrent HVLD technology uses a unique mode of DC voltage, applying no more than 50% of the voltage used on conventional high voltage technologies. The nature of the PTI solution allows for detection of leaks in packages with liquids of extreme low conductivities, including packages containing sterile water for injection (WFI). The low voltage and current applied to the product also reduce the voltage the product is exposed to during the test. This technological advantage makes it the ideal solution for all parenteral and biologic solutions.

The HVLD test method ensures product seal integrity by scanning the complete syringe to detect small pin holes, micro cracks, and closure seal imperfections. MicroCurrent HVLD has proven to be a highly sensitive leak test method for various types of liquid filled pharmaceutical packaging (pre-filled syringes, vials, blow-fill-seal containers, as well as other liquid filled packages).

Benefits:

Fast inspection method for wide range of parenteral package formats.
Robust method and good Signal-Noise-Ratio between good and defective products.
Low voltage exposure reduces production of ozone

A 6-axis articulated robotic arm will track and pick-up trays from a standard single lane conveyor transporting the nested syringe tubs. The robotic arm will pick & place the syringes from the nested trays and interact with the E-Scan module to complete testing. The test is automatically initiated and will provide a definitive pass/fail signal on test completion. After testing, the syringes will be automatically loaded into the passed tray or reject tray.

E-Scan RTX supports PTI’s Data Integrity 21 CFR Part 11 (21CFR11) and EU GMP Annex 11 compliant solution, ETHOS software.

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CCI Testing -The Importance Of Sensitivity, Automation And Efficiency

VeriPac LPX Vacuum Decay Technology Automates CCI For Parenteral Products

Sensitivity and reliability go hand in hand with CCI testing. The VeriPac LPX 430.8S is the next generation automated inspection system for container closure integrity testing of parenteral products. Automated for 100% testing or batch release, the VeriPac 430.8S is an eight-station dual chamber design robotic testing platform for pre-filled syringes and vials, testing products filled with lyophilized product, small molecule liquids and Water for Injection (WFI).

PTI’s Vacuum Decay Difference

Achieves highly sensitive testing with leak detection of critical defects down to the 1-micron range. Parenteral applications require this level of sensitivity, with the maximum allowable leakage limit (MALL) at the single digit micron level to eliminate any risk to the patient. The VeriPac LPX for parenterals also features a small footprint design. The test chambers can be swapped out for easy changeover to test vials or syringes with different fill volumes.

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