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Testing a pre-filled syringe is critical when it comes to developing and releasing safe injectables to the market. Pre-Filled syringes are becoming increasingly popular due to their efficiency and simplicity. In addition, they provide a more dependable and safe option for patients as they contain the exact dose. Container closure integrity test techniques can be utilized to satisfy the regulatory, quality, and safety demands of sterile drug products. During development, qualification, and stability testing, the FDA encourages sterile pharmaceutical manufacturers to employ established and deterministic methodologies to confirm CCI.

Ensuring Pre-Filled Syringes Integrity using SIMS 1915+

Seal Integrity Monitoring System (SIMS) Model 1915+ is a helium-based leak testing system specially designed for a variety of pharmaceutical and medical device product package systems. A pre-filled syringe is one of its applications. Vials, cartridges, and blister cards are other applications. Packages may be quantitatively evaluated to levels much above the vacuum bubble and dye penetration test procedures using helium as the tracer gas. This quantitative method supports the full lifespan by allowing direct comparison across multiple packing materials and formats, production line settings, and stability storage conditions. SIMS 1915+ allows for quantitative analysis of packages with a sensitivity as low as 1 x 10-10 mbar/L/sec and will offer meaningful data sets instead of simple pass/fail criteria.

Seal Integrity Monitoring System (SIMS) model 1915+ helium-based leak testing system from LDA includes an oil-free pump, detector, and integrated power system built for the pharmaceutical and medical device industries. The most important component is the Helium Leak Detector Module (HLDM), built into a console frame assembly with a stainless steel working surface and an optional dual test port manifold. The freestanding units are equipped with a locking wheel and an articulating arm system for attaching the computer and peripherals, making them easy to operate and move. Each SIMS 1915+ helium leak testing device is manufactured to the specifications and package configurations of the individual customer.

SIMS 1915+ Options

• Low-Temperature Add-on Systems LT 80 and LT 150 for ultra-cold CCI testing utilizing helium leak detection methods.
• Vacuum test fixtures come in a variety of sizes to meet all package types and sizes.
• Helium leak testing for non-vacuum chamber applications with custom test fixtures.
• External helium leak standards in a variety of leak rate ranges.
• Helium Sniffer Probe - for determining leak sites on a site-by-site basis.
• Vacuum clamps, O-ring seals, chamber gaskets, and other components.

Pre-filled syringes benefit the manufacturer as well as the patient. They help in reducing medication mistakes since they have fewer steps and are easier to use than empty syringes. SIMS 1915+, developed by Leak Detection Associates, is an effective technique for testing leaks in pre-filled syringes. End-users may utilize the technology to ensure that manufacturing and packaging processes are efficient and productive while still satisfying safety requirements, international regulations, and market quality standards.

The use of pre-filled syringes (PFS) as a container solution for pharmaceutical products has increased significantly in recent years. It is expected that this trend will accelerate in the future decades. Pre-filled syringes have the benefit of reducing pharmaceutical waste and extending the life of the product for the pharmaceutical industry. In general, pre-filled syringes are recognized as an effective, reliable, and convenient way to dispense drugs. In addition, many injections can be self-administered without worrying about being completely transferred from a vial. It provides a safe and effective option for patients in need of long-term pharmaceutical therapies.

When compared to the conventional vial, pre-filled syringes provide extra complexity in the field of container closure integrity (CCI) inspection. The advantages of pre-filled syringes include ease of use compared to conventional vial packaging. Pre-filled syringes eliminate the necessary procedures before you use the drug in a vial. In addition, since pre-filled syringes contain the correct dose, it helps to avoid dosing errors.

Leak Testing Pre-Filled Syringes Using Helium Mass Spectrometry

The device that detects and monitors leaks within and outside a product is called Mass Spectrometer Leak Detector. This approach makes use of helium as a tracer gas, which is utilized to fill a product coupled to a detector. Helium mass spectrometry is widely known for its suitability for non-porous packaging like vials and pre-filled syringes.

The leak detector works on the basis of a sector field mass spectrometer. In a vacuum, analyzed entering gases (Helium) are ionized. Helium ions are accelerated and separated in a magnetic field using increased voltage. Using a specific detector, the ion current is converted to an electric current. The current is accelerated and displayed on the screen by leak detection units. The current measured is proportional to both, the helium concentration and the measured leakage.

Benefits of Helium Leak Testing

• Leaks may be detected and quantified with a high degree of sensitivity.
• Due to the inert properties of helium, it does not affect the substances under test.
• The testing is mostly conducted in a dry, temperature-independent environment.
• Helium leak testing has a shorter cycle time, which lowers the cost and overall processing time.

For non-porous packaging including vials, pre-filled syringes, and cartridges, helium mass spectrometry has emerged as the new leak detection standard. Unlike probabilistic traditional methods, helium leak detection methods are preferred by manufacturers and regulators for their high sensitivity, fast test time, and detection capability. Pharmaceutical industries usually choose this process during the evaluation and eligibility stages of a new packaging process, where MALL plays an important role.

Foil pouches are commonly used when a product requires multi-layered packaging. They are utilized as the innermost layers of packaging. Since the foil pouches come into direct contact with the packaged product, they must be of the highest quality and extremely hygienic. They are typically composed of aluminum and are used to protect products from high temperatures. Furthermore, foil pouches have a low moisture vapor transfer rate. Foil pouches usually contain three to four layers. The higher the number of layers, the higher the pouch quality. Each extra layer increases the strength of the pouch.

Foil pouch integrity testing offers a unique set of challenges. The occurrence of foil punctures is an issue in most packaging techniques that use foil as the product barrier. These imperfections can occur when the foil is rolled into thin sheets and microscopic particles are rolled into the foil by mistake. Handling of the packages during the assembly of the foil and insertion of the drug product is the most typical source of the defect. Although the human eye can only reliably spot punctures bigger than 100 µm, these faults are difficult to identify. Punctures smaller than this can cause substantial ingress and, as a result, affect the effectiveness of the product.

How to Inspect Foil Pouches for Quality Control Using Helium Leak Test?

A highly sensitive method of detecting leaks in enclosed systems by using helium as a "tracer gas" is known as helium leak testing. Pre-filled syringes, foil pouches, and cold form blister cards are the most common applications of helium leak testing. Each of these package types is meant to keep out harmful environmental pollutants including debris, germs, and even gases while maintaining the sterility of the drug product inside. The leak rate is calculated from the amount of helium that escapes from the package.

The sensitivity of the helium leak detection methods makes it an ideal platform for quality control testing foil-based packaging systems. The test technique is designed to identify helium that has been trapped in the packaging system and has leaked via micro-voids in the pouch. Placing the foil pouch in the custom-designed test fixture and drawing a vacuum is the first step in a test sequence. Helium thus escapes through possible defects in the package as a result of the resultant pressure difference. The flow is directed to the analyzer cell at vacuum pressure, where the escaping helium gas is measured in the cell.

The average test cycle time is between 20 and 60 seconds. The test chamber is evacuated to the environment when the test cycle is completed and the measurement is recorded, and a new sample can be tested. The LDA HSAM helium concentration device is used to detect the helium concentration value of each pouch once all samples in the designated set have been tested. This approach normalizes the helium leak rate to 100%, allowing direct comparison of all test samples as well as the manufacturing line configuration.

Helium leak testing, one of the most commonly used CCI testing methods, is used to accurately determine the tiniest of the leaky opening in the foil pouches. Using this method, leaks can be quantified and detected with a high level of sensitivity and quality control testing. The Food and Drug Administration- FDA has long recognized helium leak detection as a consensus standard for package integrity evaluation.