How to ensure the tightness of prefilled syringes

Update:18 Mar 2021

Nowadays, there are many kinds of medicine packaging sy […]

Nowadays, there are many kinds of medicine packaging syringe products on the market, and the quality is different. So how can we correctly distinguish the quality of medicine packaging syringe products? Now make the following brief analysis based on some of its characteristics:

First of all, the current medical packaging syringes are mainly made of glass and plastic materials. Plastic infusion devices are gradually replacing glass syringes. They mainly have lower cost, higher safety than glass syringes, and are not easy to break. The production technology of the device is relatively advanced. Generally speaking, the injection molding process is used to produce the syringe. The products produced by the injection molding process are molded at one time, with no leftovers, accurate product size and uniform weight.

Second, the tightness of the syringe product is required to be high. When selecting the syringe, its tightness should be tested. Inject half of the water into the syringe, insert the piston into the syringe, remove the protective cap, and remove the remaining air. Block with a protective cap, apply an axial pressure of 30N on the push rod rubber plug inside the syringe through the push rod, and keep it for thirty seconds. There should be no leakage at the seal of the protective cap and the piston seal.

Third, the sterility of syringes must be guaranteed because they are in direct contact with drugs. Generally, syringes should be produced in a clean workshop that meets national standards. In addition, in order to ensure their sterility, if the pharmaceutical manufacturer has a higher degree of sterility Upon request, additional ethylene oxide sterilization or cobalt 60 irradiation sterilization can be performed.

As a new type of drug packaging method, prefilled syringes have the characteristics of simple use and convenient operation. The use greatly reduces the process of dispensing before the drug is used; it reduces the error of drug dosage, because the prefilled syringe contains all Precise absolute dosage, it is a brand-new device that combines the primary packaging of liquid preparations and syringes into one.

The prefilled syringe is mainly composed of a needle tube, a rubber piston, a push rod, a cone and a protective cap. The syringe components have good compatibility with drugs. At the same time, the syringe itself has good sealing performance, and the drugs can be stored for a long time. The tightness of prefilled syringes is mainly controlled by the following points:

First, adopt sealing components that comply with internationally accepted standards;

Second, when the components of the sealing system or the potting system are changed, the impact on the sealing system should be evaluated in time, and the sealing integrity should be re-verified if necessary;

Third, the verification of tightness requirements should meet the requirements of bacteria intrusion test and saturated salt water test;

Fourth, in addition to the conventional experimental methods for prefilled syringes, influencing factor experiments and accelerated experiments should also be carried out to ensure that the sealing performance of the prefilled syringe meets user requirements during the validity period.

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