How to measure insoluble particles in medical pack
Particles are everywhere. The main sources of particles on medical packaging are: particles generated by production environment, particles brought by raw materials, particles generated by operators, particles generated by production process, and pollution generated by storage time and storage conditions. Clinical medicine shows that insoluble particles not only affect the normal process of infusion treatment, but also cause pathological changes of many tissues and organs, resulting in new diseases and even death. If a large number of insoluble particles enter into the human body, they can directly cause the same reaction of heat, which is specifically manifested as temperature rise, heartbeat acceleration, shortness of breath and other symptoms Severe cases can lead to shock.
In 2017, with the continuous implementation of medical industry laws and regulations, insoluble particle detection has not only become a hot topic for medical device manufacturers, but also the packaging manufacturers of medical devices feel pressure. In the bad information released in the flight inspection, it is often seen that the initial packaging particles exceed the standard, so how is the insoluble particles detected?
In 2015 edition of Chinese Pharmacopoeia, "0903" There are clear requirements in insoluble particle inspection method, which includes photoresist method and micro counting method. Photoresist method is widely used. Its measurement principle: when particles in liquid pass through a narrow detection channel, the incident light perpendicular to the flow direction of liquid is weakened due to being blocked by particles, so the signal output by the sensor is reduced. This signal change and the cross-sectional area of particles Size dependent. When the measurement result of the photoresist method does not meet the requirements or the test object is not suitable for the measurement by the photoresist method, the micro counting method shall be used for the measurement, and the test result of the micro counting method shall be taken as the judgment basis. The experimental operation environment shall not introduce foreign particles. The operation before the measurement shall be carried out on the clean bench, and the glass instrument and other required articles shall be clean and free of particles.
Of course, for different products or packaging, using the same testing method inevitably leads to the possibility of deviation or misjudgment. Therefore, China Medical Device Industry Association and professional branches are also organizing to explore the best testing method and solicit opinions from all parties. It is reported that the medical polymer branch is expected to introduce the test standard first.
At present, the general situation of medical packaging industry is that hard plastic is better than soft plastic, and hot melt adhesive is better than hydrosol. Generally speaking, we need to work hard on design and manufacturing, that is, quality control. Quality management is easy to understand and difficult to do. We need our colleagues in the industry to work together, learn from each other, and promote and improve overall.