Sterile surgical membrane refers to a medical material made of polyurethane, polyethylene and other films as the substrate, coated with medical pressure-sensitive adhesive on its surface, used to adhere to the surgical site during the surgical process to prevent the spread of bacterial dandruff that may be carried by the skin to the surgical wound, prevent the migration of microorganisms from the deep skin around the surgical incision to the skin surface and spread to the surgical incision, thereby preventing surgical incision infection.

The viscosity of sterile surgical membranes is an important factor affecting their ability to fully exert the above-mentioned effects. This is because if the viscosity is poor, the sterile surgical membrane cannot fully adhere to the skin during the surgical process, and even separates, it will weaken the barrier effect of the sterile surgical membrane on dandruff and microorganisms, and even lose this function. At the same time, it will also bring inconvenience to surgical operations. Therefore, viscosity is an important performance of sterile surgical membranes.

The indicators that characterize the viscosity of sterile surgical membranes mainly include adhesion and peel strength.

Testing basis

The experimental process is based on the relevant provisions B.3 of the YY 0852-2011 "Disposable Sterile Surgical Membrane" standard for peel strength testing.

Test equipment

The MED-01 pharmaceutical packaging performance tester was used as the experimental equipment to test the samples

4.1 Experimental principle

The peel strength test is the force required to peel the sterile surgical membrane off a stainless steel plate. The sterile surgical membrane sample is pasted onto a stainless steel plate. During the experiment, the unfixed end of the sample is clamped separately with the stainless steel plate in the upper and lower fixtures of the equipment. The upper fixture can move upwards while the lower fixture is fixed. When the upper fixture moves upwards at the set speed, it will strip the sample from the surface of the stainless steel plate. The force value generated during the process is monitored and recorded in real-time by the force value sensor configured in the upper fixture. After the experiment is completed, the peeling strength of the sample is calculated and displayed based on the monitoring value.

4.2 Equipment parameters

The testing range of the equipment is 250 N, and it can be optionally configured with 50 N, 100 N, and 500 N, with a testing accuracy better than level 0.5, effectively ensuring the accuracy of the test results; The itinerary is 600Mm; Supports bidirectional testing modes for tension and compression, with 6 levels of free selection for the progress and return speed of the fixture, namely 10 mm/min, 50 mm/min, 100 mm/min, and 150Mm/min, 200 mm/min, 300Mm/min; Intelligent configurations such as limit protection, overload protection, and automatic return ensure the safety of user operation; One testing machine integrates 16 kinds of testing procedures such as medical appliances, foam peeling, compression, and tension, providing users with a variety of test item options; We have adopted Labthinkzui’s newly developed embedded computer system platform, combined with Zui’s new operating software, to support the LystemTM laboratory data sharing system and unify the management of test results and reports.

4.3 Scope of application

(1) This device is suitable for testing the properties of pharmaceutical packaging bags, such as 90 degree peeling, 180 degree peeling, tensile performance, tear resistance, and heat sealing strength.

(2)This equipment is suitable for testing indicators such as the puncture force of rubber stoppers, the breaking force of ampoules, the sliding performance of syringes, the tightness of the syringe body, the puncture force of injection needles, the firmness of the needle tube connection of the injection needle seat, the fit force between the injection needle seat and the sheath, and the pressure and emptying test of plastic blood bags.

(3) After special modification or configuration of special accessories, this equipment can also be used for testing various performance indicators such as rubber plug pulling force, tape unwinding force, protective film separation force, combined cover opening force, release paper separation force, etc.

(4) This device complies with multiple and international standards, such as GB 8808, YY 0852, GB/T 1040.1, GB/T 1040.2, and GB/T1040.3, GB/T 1040.4, GB/T 1040.5, GB/T 4850, GB/T 12914, GB/T 2790, GB/T 2791, GB/T2792, ISO 37, ASTM E4, ASTM D882, ASTM D1938, QB/T 2358, JIS P8113, YY 0613, YBBMore than 30 items, including 00042002.

5. Experimental process

(1) After adjusting the sample in an environment at 22 ℃ and 60% RH for 24 hours, 5 samples with a width of 25.0 mm and a length of 400 mm were cut from the surface of the sample.

(2) Take one sample, remove the protective layer, and immediately stick the sample to the middle part of the stainless steel plate. The length of the pasted sample should be at least 200Mm, the two sides of the sample are parallel to the two long sides of the stainless steel plate. After rolling along the length direction of the sample 4 times with a pressure roller, let it stand for 10 minutes.

(3)Clamp the free ends of the sample and stainless steel plate separately in the upper and lower fixtures of the equipment, set the sample name, sample width, test speed and other parameter information, click the test option, and the test will start. The device displays the real-time force value during the sample peeling process and reports the test results after the test is completed.

(4) Follow the steps in (2) and (3) to test the remaining 4 samples.