Over the past few decades, the pharmaceutical industry has experienced tremendous growth on a global scale. Assuring the quality of the packaging is of utmost importance to every manufacturer since any defect in the packaging of pharmaceuticals can have major consequences. Pharmaceutical products must be free from microbiological contamination and safe to use from the time of manufacturing until the end of their shelf life. Through contamination in the form of oxygen, humidity, or microbial entry, the stability of the drug may be negatively impacted. Container closure integrity tests with great sensitivity are needed to reduce these risks. Hence, manufacturers choose helium leak detection technology.
Overview of SIMS 1915+
Helium Leak Detection using Seal Integrity Monitoring System (SIMS) 1915+ is a highly sensitive test method for inspecting the integrity of pharmaceuticals to identify leaks. Helium as a tracer gas may be used to quantitatively evaluate packages, providing higher degrees of accuracy than conventional vacuum bubble and dye penetration test methods. This approach makes it possible to compare various package types, sizes, and configurations, as well as manufacturing line settings and storage conditions, throughout the lifespan. LDA SIMS 1915+ is a tried-and-true technique that can be used for a range of package types, including cold form blister cards, foil pouches, parenteral vials, syringes, bottles, pre-filled syringes, and other unique medical devices. It can also be used for package design, tooling qualification, production line setup, and ongoing product quality monitoring.
SIMS 1915+ Low Temperature Add-on Test Systems
In an effort to maintain product quality aspects, complex pharmaceutical and biologic compositions have led to a constant drive towards deeper cold storage. These products, which are frequently protein-based or cell or gene treatments, must be stored in conditions that may include dry ice (-78.5°C) or even liquid nitrogen (-200°C) for storage and delivery.
The packaging system such as screw or crimp cap vials in which the products are enclosed is frequently quite conventional in nature, even if the products necessitating such deep cold storage may be complex. At these temperatures, many of the materials employed in these package systems and responsible for preserving package integrity are not normally evaluated. When subjected to deep-cold or ultra-cold temperatures, elastomeric components in particular may undergo physical changes when materials reach or exceed their glass transition state, resulting in leaks at low temperatures that would not normally be visible at room temperature. This type of leakage is frequently seen in primary seal regions, such as the interface between an elastomeric closure and a glass vial, when the temperature is below -60°C. In order to minimize leakage and demonstrate a deep understanding of a package system's performance in accordance with USP 1207, manufacturers need a method for evaluating container closure integrity while at these low temperatures. This significantly led them to decide on the best package choice and design as well as assembly parameters.
PTI and LDA’s engineering team developed the LT80, or Low Temperature -80°C, Test System, for use with the SIMS range of helium leak detectors to satisfy the market need for analyzing fine leakage at low temperatures. The LT80 system, which incorporates an SP Corporation Chiller, enables simultaneous temperature conditioning, temperature monitoring, and helium leak testing of packages down to -80°C. LT80 combines the recently announced features of the market-leading, Agilent Technologies-based SIMS 1915+ with 21 CFR Part 11 compliant SIMS Software. This is available as an upgrade for current SIMS units in the field or as a complete system. The SIMS 1915+ LT80 package is the first helium leak testing equipment particularly designed for low temperature testing down to -80°C. Sample testing close to -150°C is possible with the LT150 add-on low temperature unit.
LDA (a PTI Company) is the leading global producer of specially designed leak detection systems for pharmaceuticals and medical equipment. LDA’s low temperature add-on systems are ideal for evaluating fine leakage at cold temperatures using Helium Leak Detection Technology.