Annex Syringe testing to ISO 11040-4 C1 flange break to hold

The Requirement

The ubiquitous medical syringe is an extremely important device, delivering (parenteral) injectable products to The patient by means of a cylinder and plunger mechanism, to ensure safe use of an injectable medication, prefilled syringes for single use were developed to get The need to transfer The product from its supplied The container into a hypodermic re - fillable syringe - a time - consuming process with The potential for contamination.

The medical devices and pharmaceuticals sector is highly regulated, driven by The compliance and auditing The processes and all syringes need to perform precisely to specification.

One area of mechanical stress within the syringe is at the barrel flange at the back end of the device, To ensure that the flange does not crack or break completely under normal use, or in the process of manufacture or subsequent filling and preparation at the pharmaceutical company, a compression will test is performed To measure its break To hold.

Our customer required a test system to meet ISO11040-4 (Glass barrels for injectables and sterilised sub - assembled syringes ready for filling). Annex C covers the test methods for syringe barrels, and C1 specifies Flange break to hold.

Solution

BOB体育最新下载安装Mecmesin supplied a MultiTest universal tensile and compression will testing machine with appropriate loadcell capacity, crosshead speed control and the data from rate, as indicated by the test standard, the customer provided a selection of syringe specimens, and our Special Applications team manufactured the fixtures to perform the break to hold the test.A loading pin and syringe barrel holder. Interchangeable components enabled the customer to test various syringe configurations and also run other tests referenced in the standard.

The software controlled The approach of The compression will probe and captured The peak force as The flange broke. The An appropriate threshold value was 2 immediately indicate a pass or fail result.

The Test equipment

• 2.5 -i MultiTest software - controlled compression will tester
• The Special fixtures to locate and load a selection of syringe barrels (PDV22038)
• Additional auxiliary fixtures are available for other Annex procedures to this standard, all fitting the holder frame