Single Use Syringe Testing
Plastic single use manual syringes require both aspiration and immediate injection of the drug into a patient. The act of aspiration and immediate action of injection after filling is most commonly tested to ISO 7886-1 standards. While there are several annexes in ISO 7886-1, Annex D and Annex G are most common for mechanical testing. Annex D describes a test method for liquid leakage at the syringe piston under compression. This test requires that the syringe be pre-filled, capped, and then tested axially under compression while a side load is applied to the plunger. After a 30 second force hold, the syringe must be checked for leaks. Annex G specifies a test method for quantifying the forces needed to activate the syringe plunger. This test is used to evaluate the force profile associated with both aspirating and expelling liquid from the syringe barrel.
ISO 7886-1 Annex G specifies a particular syringe fixture that includes a bottom plunger holder, a top syringe holder, and a reservoir table for holding a beaker. The Instron® ISO 7886-1 compliant fixture is fully adjustable to accommodate multiple syringe sizes. In addition, the top part of the fixture remains the same for testing to both Annex D and Annex G. Adding a side load to the fixture is easily achieved with a simple, near friction-less sled fixture that includes a range of calibrated low force weights. Both tests can be performed using Bluehill® Universal software, and we recommend using a low force load cell, such as 50 N or 100 N.