The primary container protects the drug product from external influences, such as direct sunlight, oxygen, moisture, and particulate or bacterial contaminants. But modern primary packaging needs to fulfil several other important tasks, such as enabling simple administration by the healthcare personnel or the patient itself, avoiding the escape of hazardous drugs, and being compatible with other clinical devices such as infusion bags.

Coriolis offers the comprehensive testing of the container closure and the integrity of primary packaging materials, including rubber-stoppered glass vials, prefilled syringes, double-chamber cartridges, application devices, and closed system drug transfer devices (CSTD). We also screen different primary packaging formats and products to identify the most suitable option for your drug product and production process.

Glass vials and rubber stoppers

Glass vials are a commonly used as a versatile primary container for biopharmaceuticals. Both, liquid and lyophilized formulations can be stored, whereas the latter are also freeze-dried directly inside the vial. We utilize a range of analytical techniques, many of them non-invasive, to verify that the oxygen and moisture level inside the headspace of the vial remains unchanged over the intended shelf life and even under accelerated stress conditions following ICH guidelines or custom conditions.

Evaluation of prefilled syringes

Prefilled syringes are often used to enable self-administration by the patient. Elderly people, rheumatoid patients, or children need to be able to use the syringe by themselves but cannot apply large forces on the plunger. We test the break loose and gliding forces of prefilled syringes and double chamber cartridges and compare different syringe and needle combinations to find the most suitable option for your drug product.

Closed system drug transfer devices (CSTD)

The USP <800> “Hazardous Drugs—Handling in Healthcare Settings“ provides standards for safe handling of hazardous drugs and recommends closed systems for administration to minimize the risk of exposure to healthcare personnel, patients and the environment. Regarding injectables, which must be withdrawn from the vial into a syringe and either administered to the patient or transferred to an infusion bag, this refers to closed system drug transfer devices (CSTDs). The National Institute for Occupational Safety and Health (NIOSH) defines a closed system drug-transfer device as “a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of the hazardous drug or vapor concentrations outside the system”. We follow comprehensive protocols when testing closed system transfer devices for their ability to protect healthcare workers as well as the drug product.