Introduction to Quality Requirements and Testing Methods for Pre filled Syringes in Drug Packaging Material Standards

Pre filled syringes are a new form of drug packaging developed abroad in the 1990s. After more than a decade of promotion and use, they have played a great role in preventing the spread of infectious diseases and promoting the development of the medical industry. Pre filled syringes are mainly used for packaging and storage of high-end drugs, and can be directly used for injection or for surgical flushing in ophthalmology, otology, orthopedics, and other fields.

Product characteristics of pre filled syringes

1.High quality glass and rubber components are generally used, which have good compatibility with drugs and ensure the stability of the drugs inside the packaging.

2.It can also reduce the waste caused by drug adsorption during storage and transfer, especially for high-value biochemical agents.

3.Avoid repeated suction after using diluent to reduce the chance of secondary pollution.

4.Adopting automated production line for quantitative filling of medicinal liquids, which is more accurate than manual operation by medical staff

5.The drug name can be directly labeled on the outside of the injection container, making it less prone to errors during clinical use.

6.In actual clinical use, it saves a lot of time compared to using ampoules, making it particularly suitable for emergency patients.

1、 Reference standards (partial):

YBB00062004-2015Borosilicate glass needle tube for pre filled syringes

YBB00072004-2015Chlorinated butyl rubber piston for pre filled syringes

YBB00082004-2015Brominated butyl rubber piston for pre filled syringes

YBB00092004-2015Stainless steel injection needle for pre filled syringes

YBB00102004-2015Polyisoprene rubber needle cap for pre filled syringes

YBB00112004-2015Pre filled syringe assembly(With injection needle)

2、 Introduction to Testing Projects and Testing Methods

1Borosilicate glass needle tube for pre filled syringes---121℃ particle water resistance

Take an appropriate amount of sample and measure the glass particles121Determination method and grading of water resistance at ℃YBB00252003-2015Measurement should comply with1Grade.

YBB00252003-2015The preparation method for glass particles specified in the regulations is as follows: smash the test sample into small pieces, take an appropriate amount and put it into a grinding bowl, insert the pestle, strike the pestle with a hammer, only once, and transfer the glass in the grinding bowl to the upper layer of the sieveOScreen and repeat the above process. Use vibrating screen or manual screen5Minutes will passAScreen but stayBThe glass particles on the sieve are transferred to the weighing bottle. Then conduct water resistance testing according to the measurement method specified in the standard.

Due to the requirement of the standard for particle preparation method being a single blow, the preparation process is very labor-intensive and time-consuming. After researching the standard, Theo Electromechanical has developed * that meets the requirementsYBBThe glass particle preparation instrument specified by the standard automatically strikes the particles and automatically transfers them toOScreen, with built-in automatic screening structure, reduces labor consumption and improves preparation efficiency.

2Butyl rubber piston---Compatibility between piston and push rod

(Applicable only to threaded pistons) Take an appropriate amount of sample, connect the push rod to the piston, insert the piston into a pre filled syringe lubricated with silicone oil and filled with half water, eliminate air, insert a needle guard cap into the syringe, and slowly withdraw about3mmThe distance. The push rod should remain stable and should not separate from the piston.

3Butyl rubber piston---Piston lubricity

Take an appropriate amount of sample, insert the piston into the silicone oil lubricated syringe tube, and use a push rod to push the piston into the entire syringe tube. The push rod piston should move smoothly without sudden pauses.

4Butyl rubber piston---Piston sliding performance

Take an appropriate amount of sample and place the push rod piston into a needle tube lubricated with silicone oil100mm/min±5mm/minPush the push rod at high speed. The starting force of piston sliding and the sustained force of piston sliding should comply with the provisions in the following table.

5Butyl rubber piston---Body tightness

Take an appropriate amount of sample, inject half of the water into the syringe, insert the piston into the syringe, remove the protective cap, eliminate residual air, and then block the needle with the needle protective cap. Apply axial pressure on the push rod rubber stopper inside the syringe through the push rod30N, Reserved5second. There shall be no leakage at the contact area between the needle and the needle seat, and no leakage at the contact area between the piston and the syringe.

6Injection needle---Needle puncture force

Take an appropriate amount of sample separated from the glass needle tube, and mix the injection needle with simulated skin (polyurethane, thickness)0.35mm）Preprocess according to standard requirements, take a simulated skin of appropriate size and clamp it on the fixture, without any obvious tensile or compressive force applied to the simulated skin. Install the test needle on the testing machine, with the needle tip pointing towards the circular puncture area100mm/minSimulate skin penetration vertically at a certain speed and record the maximum peak force.

7Injection needle---Connection force between needle and needle holder

Take an appropriate amount of sample and fix the syringe on the testing machine100mm/minThe speed must not be less than22NConduct a pull-out test on the injection needle under tension. The needle seat between the stainless steel needle and the glass needle tube must not be loose or separated.

8Injection needle---Pull out force of needle guard cap

Take an appropriate amount of sample, fix the needle cap and injection needle tube in the upper and lower fixtures of the testing machine, and test at a speed of100mm/minThe pulling force of the needle cap should be within4.0-45Nbetween.

The above introduces the quality control items and testing methods for pre filled packaging related products in the drug packaging material standards. We hope it can be helpful to you. Jinan Xio Electromechanical Co., Ltd. is dedicated to the research and development, manufacturing, and sales of laboratory testing instruments. Theo continuously develops and improves manufacturing processes and design concepts. The product has won wide trust from customers with excellent performance and is widely used in packaging, food, medicine, plastics, paper products, daily chemical products, quality inspection institutions, colleges and universities, and other fields.

Jinan Xio Electromechanical Co., Ltd. always puts customers at the center, insists on providing cost-effective and stable products and services, and is committed to providing quality control and research equipment for our customers.