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The design verification tests for pre-filled syringes are critical in ensuring the device’s safety, functionality, and compliance with regulatory standards. ISO 11040 has different parts that describes the requirements for the barrel or plunger of a prefilled syringe. ISO 11040-8…
Pre-filled syringes (PFS) are single-dose, pre-loaded syringes are widely used across various therapeutic areas, including vaccines, biologics, and anticoagulants. They have become a preferred method for delivering injectable medications due to their convenience, safety, and precision. In this article, we…
Main types of Combination Products for injectable biologics: Wearable Injectors: These devices are worn on the body and can automatically administer drugs over time, useful for treatments that require multiple doses, like biologics. Syringes: The most common and basic injectable…
What is a Combination Products According to 21 CFR Part 3.2, a combination product is a product comprised of two or more regulated components (drug/biologics/device) that are physically or chemically combined or mixed. any combination of a drug & a…
