US 12,296,138 B2
Prefilled syringe and method of preparing a prefilled syringe
Markus Hemminger, Basel (CH); Ulla Grauschopf, Basel (CH); Frank Bamberg, Basel (CH); Mayumi Bowen, South San Francisco, CA (US); Robert Müller, Basel (CH); Flora Felsovalyi, Basel (CH); and Denny Christensen, South San Francisco, CA (US)
Assigned to F. HOFFMANN-LA ROCHE AG, Basel (CH); and GENENTECH, INC., South San Francisco, CA (US)
Appl. No. 16/651,440
Filed by F. HOFFMANN-LA ROCHE AG, Basel (CH); and GENENTECH, INC., South San Francisco, CA (US)
PCT Filed Sep. 28, 2018, PCT No. PCT/EP2018/076445
§ 371(c)(1), (2) Date Mar. 27, 2020,
PCT Pub. No. WO2019/063785, PCT Pub. Date Apr. 4, 2019.
Claims priority of provisional application 62/565,366, filed on Sep. 29, 2017.
Prior Publication US 2020/0297919 A1, Sep. 24, 2020
Int. Cl. A61M 5/00 (2006.01); A61L 2/20 (2006.01); A61M 5/31 (2006.01); A61M 5/32 (2006.01); B65B 3/00 (2006.01); B65B 55/02 (2006.01)
CPC A61M 5/001 (2013.01) [A61L 2/206 (2013.01); A61L 2/208 (2013.01); A61M 5/002 (2013.01); A61M 5/3137 (2013.01); A61M 5/3202 (2013.01); B65B 3/003 (2013.01); B65B 55/02 (2013.01); A61L 2202/182 (2013.01); A61L 2202/24 (2013.01); A61M 2207/00 (2013.01)] 20 Claims
OG exemplary drawing
 
1. A method of preparing a prefilled syringe, comprising:
obtaining a syringe barrel having an open end and a tip with an orifice essentially opposite to the open end, and a needle adaptor cap assembled on the tip of the syringe barrel, wherein the needle adaptor cap has a rubber element tightly sealing the orifice of the tip of the syringe barrel and the syringe barrel together with the needle adaptor cap assembled on the tip of the syringe barrel is sterilized, prior to filling or sealing an interior of the syringe barrel, by performing a first sterilizing comprising a main step of exposing to the syringe barrel together with the needle adaptor cap assembled on the tip of the syringe barrel to ethylene oxide;
filling a drug substance through the open end of the syringe barrel or through the orifice of the syringe barrel into an interior of the syringe barrel;
sealing the interior of the syringe barrel by advancing a rubber stopper through the open end of the syringe barrel;
packaging the syringe barrel together with the rubber stopper sealing the interior of the syringe barrel and the needle adaptor cap assembled on the tip of the syringe barrel; and
performing a second external surface sterilizing of the packaged syringe barrel together with the rubber stopper sealing the interior of the syringe barrel and the needle adaptor cap assembled on the tip of the syringe barrel,
wherein the second external surface sterilizing comprises a main step of exposing to pulses of vaporized hydrogen peroxide the packaged syringe barrel together with the rubber stopper sealing the interior of the syringe barrel and the needle adaptor cap assembled on the tip of the syringe barrel to at least six pulses of vaporized hydrogen peroxide for at least about five minutes per pulse at a relative humidity of about 40% to about 100%.