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Pharmaceutical Network > Products > Instruments and Meters > Drug Testing Instruments > Packaging Detectors > Pros and Cons of Various Common Test Methods of CCIT

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Advantages, disadvantages and application scope of various common test methods of Shanghai Qiyi CCIT

price ¥ 2000
order amount pcs ≥1 pcs

Product Introduction INTRODUCTION

Laser headspace analysis This is a deterministic leak test method. The laser method is to determine the integrity of the container by monitoring the pressure in the headspace of the container, water vapor and headspace oxygen changes. The principle is that the emitted laser light penetrates the headspace of the container. The water vapor and oxygen in the headspace of the container absorb laser light. The corresponding substance content is proportional. The width of the headspace water vapor absorption peak is proportional to the headspace pressure, so the headspace pressure can be obtained by the headspace water vapor absorption peak width.

Product information INTRODUCTION

Advantages and disadvantages of CCIT's various common test methods and their application scope

I. High pressure leak detection method

advantage:

不需要破坏样本 1) No need to destroy the sample

可以做到100%的在线测试 2) Can do 100% online testing

高速的测试 3) High-speed test

不需要测试前的样品制备 4) No need for sample preparation before testing

其准确性独立于员工的操作技能 5) Its accuracy is independent of the operating skills of employees

在常压下测试 6) Test under normal pressure

Disadvantages:

只有通过/失败两种结果,没有定量的结果 1) Only pass / fail results, no quantitative results

药品本身的电导应该大于包装材料的电导 2) The conductance of the drug itself should be greater than the conductance of the packaging material

有可能破坏到产品(比如引起蛋白质的降解) 3) May damage the product (such as causing protein degradation)

制剂液体必须不是易燃液体 4) The formulation liquid must not be a flammable liquid

测试过程会产生臭氧 5) Ozone will be produced during the test

对于特定的包装系统,需要指定的固定装置 6) For specific packaging systems, designated fixtures are required

电极必须离泄漏点在一定的距离内 7) The electrode must be within a certain distance from the leak point

药品液体需要和泄漏点接触或者非常靠近 8) Drug liquid needs to be in contact with or very close to the leak

产品堵塞泄漏孔会导致测试结果不准确 9) Product plugging leak holes will cause inaccurate test results

不适用于冻干粉制剂产品 10) Not applicable to lyophilized powder preparation products

Application of the method and recommendations:

对于商业化生产线的高产出的检测。 -Detection of high output in commercial production lines.

需要评估产品接触到高压后的质量影响。 -Need to assess the quality impact of products exposed to high pressure.

在长期稳定性样品的泄漏测试上受限,这主要是由于长期储存过程中液体风干堵塞泄漏孔。 -Limited to leak testing of long-term stability samples, which is mainly due to liquid air-drying blocking leak holes during long-term storage.

产品的电导可能不足以检测出泄漏 -Product conductance may not be sufficient to detect leaks

可以把100%的在线检测模式整合到自动目测检查的生产线中。 -100% on-line inspection mode can be integrated into the production line for automatic visual inspection.

在100%的在线测试中依旧受到限制,这主要是由于方法有其灵敏度,只能测试到大于灵敏度的泄漏。 -It is still limited in 100% online testing, which is mainly due to the sensitivity of the method, which can only detect leaks greater than sensitivity.

当泄漏点在小瓶的顶端位置,比如在闸盖处,没有和液体产品接触到,该方法就不适用。 -This method is not applicable when the leak point is at the top of the vial, such as at the gate, and there is no contact with the liquid product.

Laser headspace analysis

This is a deterministic leak test method. The laser method determines the integrity of the container by monitoring the pressure in the headspace of the container, water vapor and headspace oxygen changes. The principle is that the emitted laser penetrates the headspace of the container. The corresponding substance content is proportional. The width of the headspace water vapor absorption peak is proportional to the headspace pressure, so the headspace pressure can be obtained by the headspace water vapor absorption peak width.

advantage:

)不需要破坏样本 1 ) No need to destroy the sample

)可以做到定量测试 2 ) Can do quantitative test

)可以做到100%的在线测试 3 ) Can do 100% online testing

)高速率的测试 4 ) High-speed test

Disadvantages:

)包装容器必须是透明的 1 ) The packaging container must be transparent

) 需要在包装瓶的顶空有可以改变的气体环境 2 ) A changeable gas environment is required in the headspace of the bottle

) 需要顶空部位有一定的空气体积供于检测 3 ) Requires a certain volume of air in the headspace for testing

) 在探测小尺寸的泄漏上,会延长测试的时间 4 ) In detecting small size leaks, it will extend the test time

)变更设备的部件时需要包含所有不同的尺寸和型号 5 ) When changing parts of the device, all different sizes and models need to be included

Application of the method and recommendations:

对于微米级孔径大小的泄漏,测试可能需要耗时几周的气体交换。 -For micron-sized pore size leaks, testing may require several weeks of gas exchange.

测试方法方便使用 -Easy to use test method

可用于评估瞬间发生的泄漏(比如测试需要低温储存的产品) -Can be used to assess transient leaks (such as testing products that require cryogenic storage)

有可能导致错误的测试结果,尤其是在稳定性研究中,由于气体的渗透或被液相吸收。 -May lead to erroneous test results, especially in stability studies, due to gas penetration or absorption by the liquid phase.

由于快速的和环境压力平衡,大尺寸的泄漏可能无法测出(比如测试低温储存的产品)。 -Due to rapid and ambient pressure equilibrium, large-scale leaks may not be detected (such as testing products stored at low temperatures).

不容易区别出不同尺寸的泄漏。 -It is not easy to distinguish leaks of different sizes.

不容易甚至不能够测试出在液面下的泄漏,因此,只适用于预灌注注射器。 -It is not easy or even impossible to test for leaks below the liquid surface, therefore only suitable for pre-filled syringes.

冻干粉制剂产品可能会导致泄漏的堵塞。 -Freeze - dried powder preparation products may cause clogging of leaks.

有部分的压力依赖于温度。 -Part of the pressure depends on temperature.

Third, the vacuum attenuation method

This is a deterministic leak test method. The vacuum attenuation method is to place a packaging container in a special test chamber and evacuate the test chamber. The pressure difference between the inside and outside of the container causes the gas inside the container to leak into the test chamber through a leak. The change value is compared with the reference value. An increase in pressure indicates a leak to determine whether the integrity of the container seal is acceptable. The test steps of this method include: evacuating, holding pressure and testing.

Advantages of this method:

)不需要破坏样本 1 ) No need to destroy the sample

) 可以做到100%的在线测试 2 ) Can do 100% online testing

)高速率的测试和产出 3 ) High-speed testing and output

)测试不会影响生产进度 4 ) Testing will not affect production progress

) 有ASTM方法可供参考(ASTM-American Society for Testing and Materials) 5 ) There are ASTM methods for reference (ASTM-American Society for Testing and Materials)

)可适用于液体和冻干粉的制剂 6 ) Suitable for liquid and lyophilized powder formulations

)可应用于有色包装瓶和贴好标签的包装瓶检漏 7 ) Can be used for leak detection of colored bottles and labeled bottles

Disadvantages:

)仪器昂贵,每种包装系统需要特定的仪器腔体 1 ) Instruments are expensive, and each packaging system requires a specific instrument cavity

)产品堵塞泄漏孔的情况下会检测不出泄漏 2 ) Leakage will not be detected if the product blocks the leak hole

)真空腔体的准备至关重要(湿度会影响测试结果) 3 ) The preparation of the vacuum chamber is very important (humidity will affect the test results)

Application of the method and recommendations:

此方法适用性很广,可用于支持产品开发,商业化,以及稳定性研究各阶段,包装容器的密封性检查。 -This method has a wide applicability, and can be used to support product development, commercialization, and stability research at all stages of packaging container tightness inspection.

适用于液体和冻干粉的制剂。 -Suitable for liquid and lyophilized formulations.

可应用于包装器械的测试,和贴好标签的包装瓶检漏。 -Applicable to the testing of packaging equipment and leak detection of labeled bottles. However, its detection sensitivity is reduced compared to unlabeled primary packaging.

只限于在线测试,并会产生假阳性结果(比如,当有滞留气体在闸盖处时;或者受到湿度波动的影响时)。 -Limited to online testing and will produce false positive results (for example, when there is trapped gas at the gate; or when it is affected by humidity fluctuations).

方法开发研究表明,该方法对冻干粉,预灌注液体的注射器,和小容量瓶液体制剂具有等同的灵敏度。 -Method development studies have shown that this method has equivalent sensitivity to lyophilized powder, pre-filled syringes, and small volume liquid formulations.

当应用于液体制剂时(黏度限制),镭射穿孔的阳性控制样本容易出现堵塞的情况;对预灌注注射器,细孔也很容易被蛋白质或硅油堵塞。 -When applied to liquid preparations (viscosity limitation), positive control samples of laser perforation are prone to blockage; for pre-filled syringes, the pores are also easily blocked by protein or silicone oil.

压力变化和泄漏的尺寸,泄漏的速率有量级的相关性。 -There is an order of magnitude correlation between the pressure change and the size of the leak and the rate of the leak. However, it cannot be distinguished whether the leak came from multiple leak holes or a single leak, or a crack at the joint of the package.

Company details

Dealer Manufacturer Nature

Area of Shanghai

Wu Nengwen Contact

Main products: instruments and meters, mechanical and electrical equipment, electronic products, machinery and equipment, wholesale and retail of first-class medical equipment, installation and maintenance of mechanical and electrical equipment

Registration time: 2019-04-23

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