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Lyophilized vials broken causes and solutions

Source:www.sumspring.cn   Release time:2016-08-16
         Vials are packaged in the form of a sterile powder for injection of drugs is now mainly used in large usage. Meanwhile, the vacuum freeze-drying technology very rapidly in China in recent years, the development of competition in the market and optimize the combination after nearly 10 years, the current form of more than 10 professional manufacturer lyophilizer. Pharmaceutical lyophilizer its technical performance has matured, the country will also develop the appropriate industry standards. From a practical point of view of production problems, since the adoption of the domestic vials found broken bottles freeze-drying process is relatively prominent issue, whereby the relevant departments have done a lot of work, from the technology, equipment, and vials quality start, finally solved this long-standing problem plagued.
        
        First, the equipment manufacturing reasons
        At present, there are still many domestic lyophilizer lack of individual companies are still in the imitation of foreign lyophilizer structure, no thorough understanding of the principles of design and manufacture. Because different overall technical quality, design structure and manufacturing process is different, there is no uniform standard. Some manufacturers product shelf flatness is not good, especially for the larger area of the shelf, after the freeze-drying proceeds tamponade, non-uniform pressure distribution, resulting in individual bottles being crushed.
 
       Second, the quality of their vials
       This is an important factor affecting the rate of broken bottles lyophilized. We know that the vials before filling, and subject to ultrasonic cleaning and autoclaving addition to heat, no matter what the procedure, is a test of the vials. Ultrasonic cleaning of impact strength and moisture glass will have a certain influence, and the distribution of the tunnel oven temperature unevenness prone to sudden thermal quenching, this is poor quality of the vials to a significant damage. Maybe change the appearance of the bottle with the naked eye can not see, but it is possible to produce tiny cracks, so that later freeze-drying process is not sufficient to withstand temperature changes. Various domestic vials were varying degrees of broken bottles appear phenomenon, serious or even more than 10%, while the rate of broken bottles vials of the best domestic and imported vials are also very different.

        Third, the impact of the freeze-drying process
        During the inspection, the quality of the vials, we focus on the lyophilization process, analyzes the causes of broken bottles. Normally when the glass uniformly heated to a greater temperature tolerance range without fragmentation, such as baking in an oven, or frozen at minus several tens of degrees Celsius environment. However, if the temperature in different parts of the same (especially the bottom) on the occurrence of a bottle or a sudden quench heat changes, the formation of relatively large temperature difference, this time will be different in different parts of the bottle expansion force, when this force more than a glass of endurance, will inevitably lead to damage to the glass.
 In this case, the process of freeze-drying is very likely to occur. The key to solving the problem of fragmentation and removal is to reduce the temperature difference between the bottom of each glass part of the freeze-drying process is to reduce the temperature curve reflects shelf temperature curve line spacing between the curves and the sample temperature. This can be achieved by vacuum control and temperature control in the actual operation.
       
       Wall Thickness Tester

       Fourth, the detection means
       In the incoming inspection, it is now a lot of testing methods for pharmaceutical vials yet related, often refer to the technical parameters of the packaging plant provided no actual situation lyophilizer. This proposal considering the quality of the vial into the factory inspection is necessary for the impact of hot and cold caused upheaval on vials, bottles need to adopt RCY-02 thermal shock tester thermal shock test.

       For vials off the bottom, the main reason is the bottom part of the bottle should stress concentration YLY-02 Polarizing Stress tester . In addition, the vials will also affect the thickness uniformity of product stability, applicable CHY-B Wall thickness tester gauge the thickness of the bottom wall thickness of the sidewall of the test. With the testing equipment to detect the three springs in the stone production company, will effectively reduce the rate of broken bottles vials.

      I hope this can bring some friends to the relevant drug benefit thinking.

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