Medline Industries, Inc.

Centurion Medical Products Corporation

Jessica Leginski

Curt Carpenter

Kelley Kuehne

Kelly Kuehne

John T Bauer

A method of sterilizing a prefilled syringe comprises assembling a syringe assembly and performing at least one ethylene oxide (EtO) sterilization procedure cycle. The assembling step includes inserting a tip cap at a first end of a plunger, filling a non-glass barrel with sterilization sensitive material at a second end of the barrel, and inserting the plunger into the barrel at a second end to seal the sterilization sensitive material within the barrel. The EtO sterilization procedure cycle comprises undergoing a preprocessing stage, a wash and conditioning stage, an EtO sterilization stage and a wash and post exposure stage. Upon completing the EtO sterilization procedure cycle, a resultant pH of the sterilization-sensitive material does not exceed an acceptable pH range as defined by the United States Pharmacopeia. The disclosure also discusses inserting an assembled prefilled syringe into a procedure tray prior to performing the EtO sterilization procedure cycle.

Methods for manufacturing non-glass prefilled syringes

A syringe assembly may include a plunger having a stopper. A barrel may be configured to receive the plunger at an open first end. A tip cap may be removably attached to the second end and may form a chamber within the barrel between the plunger and tip cap. The chamber may be configured to contain a sterilization sensitive material. The barrel may be formed of a plastic material having a high barrier property configured to create a barrier between the sterilization sensitive material and gases produced for sterilization purposes such that the sterilization sensitive material remains unchanged during a sterilization procedure.

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Chicago, IL, United States of America

Jessica Leginski