Combination products are made up of two or more regulated components, such as pharmaceuticals, devices, or biologicals, that have been physically, chemically, or otherwise combined and formed as a single entity to achieve a therapeutic effect.
Combination products can be divided into three main categories:
- Drug-device combination products: These products combine one or more drugs with a medical device. Examples include prefilled syringes, inhalers, and insulin pumps.
- Deterministic, quantitative test method.
- Biological-device combination products: These products combine one or more biological products with a medical device. Examples include drug-eluting stents and tissue-engineered products.
- Drug-biological-device combination products: These products combine one or more drugs, biological products, and medical devices. Examples include gene therapy products and combination vaccines.
Combination products can be complex and challenging to test, as they require expertise in both the pharmaceutical and medical device industries. One of the most important tests for combination products is container closure integrity testing. CCIT ensures that the product container and closure system are properly sealed and will not leak during transport, storage, and use. Leaks can lead to product contamination, degradation, and even patient harm.
CCIT is important for all combination products, but it is especially important for products that contain sterile or sensitive ingredients. Leaks can allow bacteria and other contaminants to enter the product, which can lead to serious health problems for patients. Container closure integrity testing is also important for products that are used to deliver drugs or biological products directly to the bloodstream or other sensitive tissues. Leaks can cause the product to lose its potency or efficacy, or it can even cause an overdose.
SIMS 1915+ for Leak Testing Combination Products
SIMS 1915+ is a helium-based leak detection system that is well-suited for testing combination products. It is a highly sensitive and accurate system that can detect leaks as small as 1 x 10-10 mbar L/sec. SIMS 1915+ is also very versatile and can be used to test a wide variety of combination product packages, including vials, syringes, cartridges, and blister cards.
SIMS 1915+ works by filling the test chamber with helium gas and then measuring the amount of helium that leaks out of the product package. If there is a leak, the helium leak detector will generate a signal. The size of the signal is proportional to the size of the leak.
SIMS 1915+ can be used to test combination products in both vacuum and sniffer modes. In vacuum mode, the test chamber is evacuated and then filled with helium. The helium leak detector is then used to measure the amount of helium that leaks out of the product package. In sniffer mode, the helium leak detector is used to scan the outside of the product package for helium leaks. This mode is useful for testing products that are difficult to place in a vacuum chamber, such as prefilled syringes and inhalers.
SIMS 1915+ Options
SIMS 1915+ is a modular system that can be customized to meet the specific needs of each customer. Some of the available options include:
- Dual test port manifold: Allows two product packages to be tested simultaneously
- Low temperature testing: Allows product packages to be tested at temperatures as low as -80°C.
- CFR 21 Part 11 compliance: Ensures that the system meets the data integrity requirements of the FDA's 21 CFR Part 11 regulations
SIMS 1915+ is a powerful and versatile helium leak detection system that is well-suited for testing combination products. It is a highly sensitive and accurate system that can detect leaks as small as 1 x 10-10 mbar L/sec. SIMS 1915+ is also very versatile and can be used to test a wide variety of combination product packages, including vials, syringes, cartridges, and blister cards.