The quality and safety of drugs directly affect national health. In the process of drug production, enterprises cannot overlook any details, let alone shirk responsibility for drug research and development difficulties.
Packaging, as an important component, plays a crucial role in the quality protection of drugs after they leave the factory. Strengthening the testing of drug packaging materials cannot be ignored. It is understood that accurate and precise testing of drug packaging materials can better safeguard drug safety. And China has successively issued relevant regulations to ensure drug safety, making quality inspection of drug packaging and packaging materials one of the key tasks that pharmaceutical companies must carry out.
From 2002 to 2006, the State Food and Drug Administration successively issued the "Compilation of Standards for Packaging Materials and Containers in Direct Contact with Drugs" to unify and standardize the quality standards and inspection methods of drug packaging materials. In 2004, the "Management Measures for Packaging Materials and Containers in Direct Contact with Drugs" were issued, clarifying the types of drug packaging materials that are subject to registration management and conducting spot checks on the production and circulation of drug packaging materials. The 2015 version of the drug packaging material standard has made significant improvements in terms of terminology specifications, inspection methods, testing limits, and other quality control aspects. It has positive significance for further promoting the construction of China's drug packaging material standard system, improving the quality of drug packaging materials and drugs, promoting the development of the drug packaging material industry, and ensuring the safety and effectiveness of public drug use.
Whether the drug packaging materials are qualified and whether the quality is guaranteed not only requires the manufacturer to strictly produce according to the standards, but also the testing process is an important link that cannot be ignored. In the process of drug packaging material testing, drug packaging material testing instruments play an important role. Industry insiders say that drug packaging material testing instruments are related to people's medication safety and must be precise and rigorous.
It is understood that the relevant standards for drug packaging and material testing and control mainly include barrier performance, mechanical performance, smoothness, thickness, solvent residue, sealing performance, bottle cap torque, headspace gas analysis, printing quality, etc. relatedThe testing instruments for pharmaceutical packaging materials include ampoule breaking force tester, pharmaceutical packaging tearing force tester, circular jumping tester, wall thickness gauge, pharmaceutical aluminum foil rupture resistance tester, polarizing stress tester, glass bottle internal pressure resistance tester, and glass bottle thermal shock resistance tester.
In recent years, with the continuous advancement of technology, the technology of drug packaging material testing instruments in China has also been significantly improved. Following the national drug packaging material policy, many enterprises are committed to drug packaging material testing, constantly upgrading, updating, and replacing testing instruments to provide overall solutions for the pharmaceutical industry to meet market demand, including the birth of various advanced instruments. The two instruments recently launched by Jinan Zhongnuo, "ZNCRT-01 Electronic Axis Deviation Tester" and "DBH-01H Electronic Wall Thickness Bottom Thickness Tester", are more intelligent during testing, greatly reducing the workload of operators and errors caused by human factors, achieving comprehensive automation of sampling and measurement.
The value of today's pharmaceutical packaging material testing instruments lies in their precision, rigor, and small errors. Taking the plastic film thickness gauge as an example, the focus of enterprises will no longer be on factors such as price, but on the resolution and testing accuracy of the instrument. The higher the resolution and accuracy, the more accurate the test data, which directly helps manufacturers in product development on the production line. According to industry insiders, with the arrival of the intelligent era, intelligent automation technology will be widely used in pharmaceutical packaging material testing instruments, which will greatly improve the detection accuracy and efficiency of the instruments.
Serving the people is our duty, improving the quality of pharmaceuticals and ensuring the safety of people's medication is the duty of every pharmaceutical company. The quality of drug packaging materials is closely related to the quality of drugs. Ensuring the quality of drug packaging materials is not only the focus of pharmaceutical companies, but also the focus of drug packaging material testing instrument manufacturers. According to the new version of GMP requirements, pharmaceutical factories need to confirm the quality and conduct necessary testing on the auxiliary materials and packaging materials used when entering the factory. In addition, the 2015 version of the Chinese Pharmacopoeia includes pharmaceutical packaging materials as part of drugs. Therefore, it is necessary for pharmaceutical factories to conduct quality inspection and control on packaging materials. In this testing process, the more accurate and efficient the drug packaging material testing instruments are, the better they can serve pharmaceutical companies' testing of drug packaging materials, improve their production efficiency, and ensure the safety of people's medication. Improving the accuracy and efficiency of drug packaging material testing instruments is our duty. We need to continuously innovate our technology, strive to make our equipment more precise and efficient, and provide a good guarantee for people's medication safety! "Said a company leader in an interview.