Vials, Ampoules & Syringes
The nondestructive testing technology of BMI verifies the sealing integrity of containers through deterministic quantitative testing of vials, ampoules, pre filling and automatic syringes.
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The nondestructive testing technology of BMI verifies the sealing integrity of containers through deterministic quantitative testing of vials, ampoules, pre filling and automatic syringes. US Pharmacopoeia USP 1207, China CDE (Technical Guide for Sealing Research of Chemical Injection Packaging System) encourages the use of deterministic, quantitative and reliable nondestructive testing technology to meet quality standards.
Parenteral products are usually packaged in a variety of packaging forms. The following forms are common - packaging containers such as vials, ampoules, syringes, BFS and automatic syringes, as well as containers filled with lyophilized products.
Any damage in the package may cause microbial contamination of the product due to exposure to the air. Therefore, container sealing integrity is an essential stage in the life cycle of sterile drugs. Defects in the integrity of the container seal may cause harm to the patient. Life saving drugs may lose their efficacy or even cause fatal side effects. CCI defects can lead to oxidation and have a significant impact on the effectiveness and shelf life of drugs.
Test method selection:
The selection of the appropriate container closure integrity test (CCIT) method depends on the production process of the product and the requirements and purposes of the test. When determining the appropriate CCI test method, the factors to be considered include the sensitivity and reliability of the test method, materials for primary packaging, and offline test requirements. Appropriate CCI testing methods can detect quality defects before product contamination and ensure patient safety. It also reduces the risk of catastrophic defects and product recalls.
The test technologies for packaging integrity test of such products include vacuum attenuation and pressure attenuation technology, high-voltage discharge technology in some cases, and headspace gas analysis technology in others.
BMI-MD vacuum attenuation technology
Meet ASTM test methods and FDA standards
Conform to the requirements of CDE (Technical Guide for Sealing Research of Chemical Injection Packaging System),
Fully comply with USP-1207.
Defect detection as low as 1 μ m。
Measure the sealing integrity of the entire container or package
Gas leak test of dried products (freeze-dried vials, powder filling)
Liquid leak test (liquid filled vials, ampoules, vials and pre filled syringes, BFS)
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