The present disclosure is directed to adapters for mixing vials of drug products, and more specifically to multi-vial adapters for reconstituting lyophilized drug products and/or diluting concentrated drug products. It is an object to address one or more of drawbacks in connection with the drug preparation process, for example, by simplifying the procedure where multiple vials are required to be diluted or reconstituted in a serial manner. As such, the multi-vial adapters described herein simplify the complexity of preparing and handling multiple vials of drug product, which significantly reduces preparation time, addresses dosing-related challenges like weight-based preparation, reduces drug waste issues, and reduces risks associated sterility and contamination, among other benefits.

Systems and methods involve a vial assembly system comprising a vial assembly and needle. The vial assembly comprises a septum, neck region, and particulate region comprising a bypass valve, the neck region comprising a top, bottom, and sidewall. The needle comprises a port and a tip configured to puncture the septum that is configured to receive the needle such that the port is disposed in the neck region. A bypass path includes a first end and a second end, the bypass valve is connected to the first end, the second end ends at or within the sidewall, the bypass path is configured to provide a fluid flow path to the needle alternate to a first path upon a build-up of pressure for fluid flow in the vial assembly, and the first path is directly disposed in the vial assembly between the particulate region and the neck region.

An adapter (650) for transferring fluid between a first device (100) and a second device (800). The adapter comprises a first end (652) for receiving the first device, wherein the first end includes a side wall for locating around the first device (100). The adapter (650) further comprises a second end (654) for engaging the first device (100), and including a retaining member (656;658;662), wherein the retaining member (656;658;662) is operable to prevent removal of the first device (100) from the adapter (650) upon engagement of the first device (100) with the second end (654). The first end (652) and the second end (654) are open on both ends to comprise a through-bore extending through the adapter (650). In some cases, the first device (100) may be a drug pen containing insulin.

In certain embodiments, a vial access device for removing liquid contents from a vial includes a piercing member extending from a base of an insertion member and a reservoir. The reservoir can be contained within the piercing member and the insertion member, such that the reservoir is introduced to the vial when piercing member is inserted into the vial. The piercing member is adapted to be opened inside the vial to expose the reservoir to the contents inside the vial. A locking mechanism can prevent the piercing member from being inserted into the vial unless the vial access device is fully coupled to the vial and/or prevent the piercing member from being withdrawn from the vial without uncoupling the vial access device from the vial.