Importance of pharmaceutical packaging materials and standardization of testing

As an inseparable part of drugs, drug packaging materials are an important guarantee to ensure the safety and effectiveness of drugs
.

Pharmaceutical packaging materials have always been considered to be part of pharmaceuticals, and the materials used in packaging will also affect the effectiveness, safety and stability of pharmaceuticals, which is also the purpose of pharmaceutical packaging testing
.

Commonly used pharmaceutical packaging materials are paper products, plastics, glass, metal, wood, review materials, rubber products, etc.
From the perspective of development trends, packaging materials are replacing wood with paper, plastic instead of paper or paper.
, plastic, aluminum foil and other composite materials composed of the direction of development
.

Composite material is a new type of packaging material, which is a packaging material made of plastic, paper, aluminum foil and other multi-layer composites
.

Commonly used are paper-plastic composite materials, aluminum foil-polyethylene composite materials, aluminum foil-polyester ethylene and so on
.

Drug packaging testing data show that these composite materials have good mechanical strength, biological corrosion resistance, vacuum retention performance and compressive performance, etc.
, which are a combination of many favorable factors
.

 Performance testing of pharmaceutical packaging materials In addition to certain mechanical properties, barrier properties and good safety performance, packaging materials must also have suitable processing performance and good economic performance
.

For the drug packaging testing of the performance of drug packaging materials, from the perspective of national supervision, special attention is also paid to the testing specifications for performance
.

　　In the 2020 version of the Chinese Pharmacopoeia, which was officially implemented on December 30, 2020, 16 new general drug packaging testing methods were added, and the drug packaging testing in terms of barrier properties, physical and mechanical properties, and biosafety properties of pharmaceutical packaging materials was elaborated.
Standardization, and through the continuous improvement of the standard system of pharmaceutical packaging materials to help the development of drugs
.

　　On September 1, 2021, the website of the China Pharmaceutical Packaging Association released the "Guidelines for Research on the Self-Stability of Plastic and Rubber Pharmaceutical Packaging Materials" (T/CNPPA3017-2021), which will be implemented from the date of publication.
*Guidelines for the study of self-stability of plastic and rubber pharmaceutical packaging materials
.

　　With the reform of domestic drugs, the corresponding supervision mode of drug packaging has also undergone tremendous changes, from no restrictions on drug packaging to the implementation of the production enterprise licensing system, to the "registration management system" of drug packaging, and then to "related review and approval" It can be seen that the supervision of drug packaging materials is more refined and clear
.

　　Labthink Packaging Safety Testing Center was founded in 2000 and is affiliated to Jinan Languang Electromechanical Technology Co.
,
Ltd.

The testing center covers an area of ​​410 square meters, of which the testing site is 360 square meters, with 120 sets (sets) of main instruments and equipment, with a total value of more than 30 million yuan.
The business includes two major sections: scientific research laboratory and cloud testing laboratory, covering barrier, strength , heat sealing, hot adhesion, friction coefficient, thickness, tearing, impact, heat resistance, leakage, rubbing, bonding, color, fastness, chromatography and other testing items
.

 Introduction of testing capability and scope: 1.
1 Film and paper barrier property testing: 1.
1.
1 O2, N2, CO2, air and inorganic gas permeability testing of various films and papers
.

1.
1.
2 Water vapor permeability testing of various films and papers
.

1.
2 Physical properties testing of various films and papers: such as tensile strength, tensile strength, heat sealing strength, peel strength, tear resistance, thickness, etc.
Common test materials: PE, LDPE, HDPE, PP, BOPP, CPP, PET, PA, EVOH, EVAL, PVC, PVDC, AL, KOP, KPET, KPA, KMF, PET aluminized, CPP aluminized, matte BOPP, PA/AL/CPP, PA/PU, PET/AL/PA, PE /AL/PET, five-layer co-extruded film, seven-layer co-extruded film, etc.

.

1.
3 Detection of oxygen barrier and water barrier of various finished containers and bottles, film bags
.