PTI Packaging Technologies and Inspection
SIMS 1915+Optimal solution for helium-based leak detection for a variety of pharmaceutical & medical device product package systems
The Seal Integrity Monitoring System (SIMS) 1915+, is the optimal solution for helium-based leak detection for a variety of pharmaceutical and medical device product package systems. Common applications include vials, syringes, cartridges and blister cards. For parenteral products, common applications for helium include leak testing the rubber stopper on a vial or the plunger on a syringe or cartridge assembly.
Using helium as the tracer gas, packages can be quantitatively tested to levels far exceeding the vacuum bubble and dye penetration test methods. This quantitative approach allows direct comparison across various packaging materials and formats, production line settings and stability storage conditions, supporting the entire lifecycle.
This SIMS 1915+ will enable the quantitative analysis of packages at a sensitivity level as low as 1 x 10-10 mbar/L/sec. and provides relevant data sets in place of a simple pass/fail criteria while enabling testing to be performed at room temperature.
Each SIMS 1915+ Helium Leak Testing instrument is custom built to client specific standards and package configurations. We specialize in the engineering and development of custom test fixtures tailored to the component to be tested, which ensures precision and accuracy to meet your study goals, package configurations and quality monitoring needs.
• Helium Leak Detector Module (HLDM): Oil Free, Production version in Console Frame Assembly, with Stainless Steel working surface.
• Vacuum Test Fixture Model (VTFM) – custom designed for use in testing package or container samples.
• Nitrogen Vent Supply system for the Helium Leak Detector Module (HLDM).
• Data Acquisition & Analysis Module running SIMS (ver. 2.0.5) 21 CFR Part 11 Compliant Leak Rate & Concentration Custom Software.
• External Calibrated Helium Leak Standard for System Calibration/Validation.
• Headspace Analyzer Module (HSAM) – Model VM-2 or UM-2A that includes three (3) Puncture Probes (two spares) for determination of Helium Concentration in the headspace of vial containers or blister card cavities. Includes Integral Calibration Chamber (and Calibrant Gas Flow Meter/Controller) provided for HSAM Calibration, and a Universal Holder to be used for various
• vial diameters.
• Dual Test Port Manifold (allows concurrent use of VTFM & HSAM on HLDM unit).
• Rotary Valve Box – for 3 Helium Calibration Gases (HSAM) & Nitrogen Gas (HLDM) Inlet Vent.
• Helium Filling Device specific for vial testing sample prep to enable vials to be filled with helium.
| Test Method | Helium |
| Application | Testing and evaluation during package design and development, tooling qualification, production line setup and on-going product quality monitoring. |
| Package Type | Cold form blister cards, foil pouches, parenteral vials, cartridges, pre-filled syringes, bottles, combination product systems and medical device products. |
| Test Configuration | Console frame assembly with stainless steel working surface, including an articulating arm for mounting of computer monitor and keyboard. |
| Operator Interface | Customer supplied Window 10 (Pro) PC interface |
| Minimum Detectable Leak Rate | 1 x 10-10 mbar L/sec. |
| CFR Security Capability | Data Acquisition & Analysis Module running SIMS (ver. 2.0.5) 21 CFR Part 11 Compliant Leak Rate & Concentration Custom Software |
| System Dimensions | 25.5” (764mm) W x 30.25” (508mm) D x 38.5” (1153mm) H |
| Dimensions with Monitor arm | 44.0” (111.8cm)/63.0” (160.0cm) Additional width and height |
| Weight | 258 lbs. (117.3 kg.) |
| Power | 100-240 VAC: 50/60 cycles |
| Options | Validation Qualification Package (IQ/OQ/PQ) |
| Test Method | ASTM F2391-05, Vacuum & Sniffer Modes Recommended in USP <1207> FDA Recognized Standard - Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas |
| Backing Pump | Oil Free (No Exhaust) Backing Pump |
| Max Inlet Pressure | 1.3 kPA |
| Operating Temperature | 10-40° C |
| PTI SIMS 1915+ - Data sheet 2.8 MB |
