{"id":5312,"date":"2023-10-02T09:15:37","date_gmt":"2023-10-02T08:15:37","guid":{"rendered":"https:\/\/sepha.com\/?post_type=test-methods&#038;p=5312"},"modified":"2024-04-29T16:38:38","modified_gmt":"2024-04-29T15:38:38","slug":"container-closure-integrity-testing","status":"publish","type":"test-methods","link":"https:\/\/sepha.com\/test-methods\/container-closure-integrity-testing\/","title":{"rendered":"CCIT"},"content":{"rendered":"<p><strong>Vacuum Deflection explained<\/strong><br \/>\nVacuum deflection is a non-destructive and deterministic leak test method to test the integrity of pharmaceutical blister packs. It is often used for batch testing in production environments and during stability trials. Vacuum deflection by laser measurement is an approved ASTM F3169-16 method for leak detection in blister packaging.<\/p>\n<p><strong>How does Vacuum Deflection testing work?<\/strong><\/p>\n<p>To conduct a vacuum deflection test, a blister pack is placed inside a test chamber. The surface of the blister pack is scanned by a laser, to provide a data point for subsequent deflection measurement. A vacuum is applied, and the pack surface is scanned a second time. The vacuum level is then reduced, and the pack is scanned once more.<\/p>\n<p>Deflection refers to the difference in the height of a cavity under vacuum compared to the first data point. A cavity with a large hole will show no difference, as the hole allows the pressure inside the pocket to equalise to the applied vacuum inhibiting foil movement.<\/p>\n<p>If there is no hole present in the cavity, the lidding foil will move, and the second scan will show a large deflection as the cavity expands as a result of the applied vacuum.<\/p>\n<p>Cavities with small holes will initially expand because of the applied vacuum. The third scan is required to identify small holes. The variation in the average height at full vacuum and reduced vacuum is referred to as collapse. If the collapse is greater than normal, a small hole is present. This occurs as the air slowly escapes through a small defect, allowing the pressure inside the pocket to equalise with the applied vacuum.<\/p>\n<p><strong><br \/>\nWhat type of containers can typically be tested using vacuum deflection?<br \/>\n<\/strong>The vacuum deflection method is used for non-porous blister packs sealed with flexible lidding material. These typically consist of thermoformed polymer or cold formed alumimum trays that contain tablets or capsules in individual blister pockets. The formed trays can be sealed with a polymer, foil or paper lidding material.<\/p>\n<p>The method is non-destructive and is a clean alternative to blue dye testing. Results are deterministic as the method will give a pass or fail result based on set parameters. Depending on material, cavity size, blister pocket headspace, printing, texture and test requirements, the vacuum deflection test method can detect defects between 7\u00b5m and 50\u00b5m.<\/p>\n<p><strong><br \/>\nWhat is Volumetric Measurement?<\/strong><br \/>\nVolumetric measurement is non-destructive measurement technology to identify defects in blister packs. It uses a 3D sensor to measure deflection of blister packs surfaces in response to an applied vacuum.<\/p>\n<p>Volumetric measurement is an alternative technology to 2D laser and light intensity techniques used in the vacuum deflection test method by lasers. It measures volumetric change of individual blister pockets before and after vacuum.<\/p>\n<p>Sepha has developed a patented 3D Leak Detection technology that provides sensitive results as low as 5 \u00b5m. The new technology can be applied to all foil types, including busy text patterns. Different pack configurations can be tested with one setting, allowing for easy calibration, quick set up times, and a streamlined validation process across different foil types.<\/p>\n","protected":false},"parent":0,"menu_order":0,"template":"","acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Container Closure Integrity Test (CCIT) - Methods explained<\/title>\n<meta name=\"description\" content=\"Container Closure Integrity Test is a key evaluation of container closure systems&#039; ability to maintain a sterile barrier against contaminants\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sepha.com\/test-methods\/container-closure-integrity-testing\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Container Closure Integrity Test (CCIT) - 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