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The gas tightness and sterility test of disposable oral medical syringe

Jason Dec 21,2018 Share this post:

In the packaging market,the oral syringe's varieties are a lot,and some are good, others are bad.So when you choose this disposable oral medicial syringe,you need know how to distinguish the good and bad of this syringe's quality.

Today I will tell you the methods to test this syringes' gas tightness and sterility.

First,i will introduce the method of testing gas tightness.

Because of a relatively high requirement of syringe's airtightness,so when you choose this type syringe,you should test the airtightness.How to test?First you fill half water in this syringe,then insert the plunger into the barrel of syringe,then put the cap of syringe tip,then push the plunger,discharge the residual air of the syringe,then lid the tip cap,then exert 30N axial force on the plunger in 30s,then observe the seal of tip cap with tip and the seal of plunger with barrel wether leak.

Second,I will introduce the method of testing sterility.

Because the oral syringe is generally packaged medicine or supplement,the syringe inside wall will directly contact the products,so the oral syringe must be sterile,to protect the products from the bacteria.In the syringe factory,this disposable oral medical syringe is generally produces in clean workshop,and if the medicine manufacturers have more higher requirement of this syringe,the syringe manufacturers can sterile the syringe with EO sterilization or Co60 radiation sterilization.

When you choose this syringe,you should do the sterilization test,according USP.

Interpretation of Sterility Test Results,Growth is determined by viewing the media, which is generally clear and transparent, against a light source. Turbid (cloudy) areas in the media are indicative of microbial growth. Once growth is detected, the suspect vessel is tested to confirm that the turbidity present is due to microorganisms and not due to disintegration of the sample; sometimes samples produce turbidity because of particulate shedding or chemical reactions with the media. Once a suspect container has been tested, it should be returned to the incubator for the remainder of the incubation period. Samples that render the media turbid are transferred on Day 14 of the test and incubated for four days. Growth positive samples require further processing such as identification and storage.

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