Knowing about the stability of pharmaceutical packaging materials

On September 1, 2021, the official website of China Medical Packaging Association issued the "Guidelines for the Study of the Stability of Plastic and Rubber Pharmaceutical Packaging Materials" (T/CNPPA3017-2021), which will be implemented from the date of publication on September 1, 2021.

This article sorts out the difficulties in the supervision of pharmaceutical packaging materials and the key points of its own stability implementation, which can provide references for pharmaceutical packaging materials companies to carry out research on the stability of pharmaceutical packaging materials

01 Supervision of domestic pharmaceutical packaging materials

Pharmaceutical packaging materials play an important role in ensuring the safety and effectiveness of drugs

In recent years, with China’s drug reform, the corresponding regulatory model for pharmaceutical packaging materials has also undergone tremendous changes.

In the review and approval of the drug packaging material association, the drug MAH is the first person responsible for drug quality, but this does not mean that the responsibility of the drug packaging material manufacturer has become lighter

Research on the stability of pharmaceutical packaging materials is generally carried out by pharmaceutical packaging material manufacturers to confirm the quality stability period of their products under specified storage conditions.

The quality stability period of pharmaceutical packaging materials refers to the stable period of pharmaceutical packaging materials from the date of production of the pharmaceutical packaging materials to the expiry date of the drug

In the drug packaging materials registration application data project, it is necessary to provide the stability research data of the pharmaceutical packaging materials.

02 Key points for the implementation of research on the stability of pharmaceutical packaging materials

1.

The purpose of the research on the stability of the pharmaceutical packaging materials is to investigate the law of the packaging materials and containers directly in contact with the drugs over time under the specified temperature and humidity environment, for the establishment of the storage conditions of the pharmaceutical packaging materials and the determination of the pharmaceutical manufacturer The deadline for the combination of medicine packaging materials and medicines provides a scientific basis

From the point of view of materials, some products used for pharmaceutical packaging have aging or stability problems due to environmental factors.

2.

At present, self-stability research can be divided into influencing factor test, accelerated test and long-term test.

03 How to consider the conditions for research on the stability of pharmaceutical packaging materials?

The research on the stability of pharmaceutical packaging materials should explore and optimize the research conditions according to the purpose of the research and the characteristics of the product.

1.

Literature research is preferred

2.
Accelerated test:

According to the commercially available packaging or packaging equivalent to the commercially available packaging, place it at the selected temperature and humidity until the required accelerated aging time
.
The equipment used in the accelerated aging test should be able to control temperature ± 2°C, relative humidity ± 5%, and be able to monitor and automatically record the real temperature and humidity in real time
.
The accelerated aging factor method is a simple and rigorous technique for studying the long-term effects of pharmaceutical packaging materials.
The accelerated test should be carried out at the same time as the long-term test
.
Examples of accelerated aging principles and parameter determination are as follows:

Examples of accelerated test conditions

3.
Long-term test:

Under the conditions of temperature 25℃+2℃ and relative humidity 60%±10%, place it for the expected stable period (for example, not less than 3 years)
.
It is recommended to sample once every 6 months (including the zero time), and test according to the stability inspection project
.
The measurement results shall be comprehensively evaluated according to the approved or planned quality standards for pharmaceutical packaging materials to determine the quality stability period of the pharmaceutical packaging materials
.

(1) For the pharmaceutical packaging materials expected to be used for packaging refrigerated drugs, the long-term test conditions should be placed under normal temperature and humidity conditions (for example, at least 1 year), and then placed at 5°C + 3°C for 2 years
.
Perform testing according to the above-mentioned time requirements to establish a stable period for refrigerated pharmaceutical packaging materials
.

(2) For the pharmaceutical packaging materials expected to be used for packaging frozen drugs, the long-term test conditions should be placed under normal temperature and humidity conditions (for example, at least 1 year), and then placed at a temperature of 20℃+5℃ for 2 years
.
Perform testing in accordance with the above-mentioned time requirements to establish a stable period for frozen pharmaceutical packaging materials
.

(3) For the drug packaging materials that are expected to be packaged and stored at other temperatures, the long-term test conditions should be placed under normal temperature and humidity conditions (for example, at least 1 year), and then placed at the corresponding drug storage temperature for 2 years
.
Perform testing according to the above-mentioned time requirements to establish a stable period for drug packaging under other storage conditions
.

(4) If the validity period of the medicine stored in refrigeration, freezing or other temperature exceeds 2 years, it should be stored under refrigeration, freezing or other conditions for the required time
.

04 What are the key investigation items for the research on the stability and stability of pharmaceutical packaging materials?

The stability evaluation index of pharmaceutical packaging material itself is more complicated.
Stability experiments should be carried out according to the composition characteristics of different varieties.
It can be formulated according to the characteristics of pharmaceutical packaging materials.
The reference expression examples of plastic and rubber pharmaceutical packaging materials product inspection items are as follows surface:

Reference table of inspection items for plastic and rubber pharmaceutical packaging materials

references

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