Sterilization method for medical rubber part
A sterilization method for a medical rubber part is a sterilization method for a medical rubber part that can include a body made from an elastic material and that can include an inactive resin film stacked on at least a portion of a surface of the body, where the sterilization method can include irradiating a packaging article with gamma ray, the packaging article accommodating a plurality of the medical rubber parts and having an oxygen concentration not higher than 5%.
1 . A sterilization method for a medical rubber part that includes a body made from an elastic material and that includes an inactive resin film stacked on at least a portion of a surface of the body, the sterilization method comprising:
irradiating a packaging article with gamma ray, the packaging article accommodating a plurality of the medical rubber parts and having an oxygen concentration not higher than 5%,
wherein the elastic material is a cured product of a medical rubber composition containing a (a) base polymer containing a halogenated isobutylene-isoprene rubber and a proportion of the halogenated isobutylene-isoprene rubber contained in the (a) base polymer is not lower than 90% by mass.
2 . The sterilization method for the medical rubber part, according to claim 1 , further comprising irradiating a packaging article with the gamma ray, the packaging article having an oxygen concentration not higher than 3%.
3 . The sterilization method for the medical rubber part, according to claim 1 , wherein the packaging article having an oxygen concentration not higher than 5% is a packaging article in which nitrogen is sealed.
4 . The sterilization method for the medical rubber part, according to claim 1 , wherein the packaging article having an oxygen concentration not higher than 5% is a packaging article in which an oxygen adsorber is sealed.
5 . The sterilization method for the medical rubber part, according to claim 1 , further comprising performing irradiation with the gamma ray such that an absorbed dose of the gamma ray is not lower than 15 kGy.
6 . The sterilization method for the medical rubber part, according to claim 1 , wherein the elastic material has a JIS-A hardness not lower than 30 and not higher than 70, and has a compression set not higher than 20%.
7 . The sterilization method for the medical rubber part, according to claim 1 , wherein the inactive resin is polytetrafluoroethylene (PTFE), tetrafluoroethylene-ethylene copolymer, or ultrahigh-molecular-weight polyethylene.
8 . The sterilization method for the medical rubber part, according to claim 1 , wherein the inactive resin film has a thickness of 10 μm to 150 μm.
9 . The sterilization method for the medical rubber part, according to claim 1 , wherein the medical rubber part is a rubber plug for a vial, a cap or a plunger stopper for a syringe, or a rubber plug for a vacuum blood collection tube.
10 . The sterilization method for the medical rubber part, according to claim 1 , wherein the (a) base polymer consists essentially of the halogenated isobutylene-isoprene rubber.
11 . The sterilization method for the medical rubber part, according to claim 10 , wherein the medical rubber composition contains a triazine derivative as a (b) crosslinking agent.
12 . The sterilization method for the medical rubber part, according to claim 11 , wherein the (b) crosslinking agent consists essentially of the triazine derivative.
13 . The sterilization method for the medical rubber part, according to claim 12 , wherein the medical rubber composition contains no vulcanization accelerator.
14 . The sterilization method for the medical rubber part, according to claim 12 , wherein the triazine derivative includes a compound represented by a formula (1):
wherein in the formula (1):
R represents —SH, —OR 1 , —SR 2 , —NHR 3 , or —NR 4 R 5 , where R 1 , R 2 , R 3 , R 4 , and R 5 each represent an alkyl group, an alkenyl group, an aryl group, an aralkyl group, an alkylaryl group, or a cycloalkyl group,
M 1 and M 2 each represent H, Na, Li, K, ½Mg, ½Ba, ½Ca, an aliphatic primary, secondary, or tertiary amine, a quaternary ammonium salt, or a phosphonium salt.
15 . The sterilization method for the medical rubber part, according to claim 5 , wherein the irradiation is performed in a dose that falls within a range of not lower than 1.4 times 25 kGy and not higher than 2.0 times 25 kGy.