Drugs
Whether it is biological drugs, chemical synthetic drugs or traditional Chinese medicine preparations, packaging plays a role in protecting the safety of products throughout the life cycle of drugs.
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Whether it is biological drugs, chemical synthetic drugs or traditional Chinese medicine preparations, packaging plays a role in protecting the safety of products throughout the life cycle of drugs. It acts as the main sterile barrier in the drug delivery process, so the effectiveness of the main sterile barrier and functional components is critical to the safety of patients. In recent years, with the rapid development of the pharmaceutical industry in the field of new drug research and development, and continuous breakthroughs have been made in the field of drug delivery systems; The regulatory authority is constantly strengthening the review, so it also highlights that the container sealing integrity goes beyond the quality characteristics, and the container sealing integrity determines the safety of drugs in use.
Any negligence of CCI will be taken seriously by the regulatory authority, so the selection of appropriate container sealing integrity test (CCIT) methods should not only conform to the quality standards recognized by the pharmaceutical manufacturers, but also have the certainty and reliability of the industry quality standards supported by the guidance documents.
BMI is committed to the research on the sealing of packaging systems, and its products are mainly used for:
Sealing test for pre filled syringes, glass tubes/molded injection bottles (vials), glass/plastic ampoules, soft bags/bottles for infusion, various plastic strip packaging, cartridge bottles, oral bottles, bulk drug containers, eye drops bottles, sealed bottles, active drug containers and other packaging containers.
The US Pharmacopoeia issued guidelines in 2016, pointing out that the deterministic method is superior to the probabilistic test method, and the Chinese Pharmacopoeia is also actively preparing for updating. The vacuum attenuation test methods provided by BMI are nondestructive, deterministic and quantitative, ensuring the highest level of integrity test. It can provide repeatable and reliable test results for CCI testing of high-risk packaging applications. The BMI detection system meets the industry standards in terms of sensitivity, reliability and stability.
It meets the requirements of ASTM test methods and FDA standards, CDE (Technical Guide for Sealing Research of Chemical Injection Packaging System), and USP-1207.
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