The dye penetration test specified in ASTM F1929 can be conducted.
- This test is a method established by ASTM to detect seal leaks in medical packaging using a dye penetration solution. - The dye is applied to the seal area between transparent materials and porous sheet materials, and the presence or absence of defects (leaks) in the channels is visually confirmed. - ISO 11607-1 states that as part of packaging system performance testing, "the integrity of the sterilization barrier system must be demonstrated after sterilization and subsequent performance testing." Annex B of this standard describes ASTM F1929 as the standard test method for evaluating seal integrity in medical packaging. - This test method is recognized by the FDA as a consensus standard. ▼ For more details, please download the PDF document (recommended). ▼ If you need immediate assistance, please contact us using the "Contact Us" option below.
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[Testing Procedure] ・Method A: Injection Method Make a hole approximately in the center of the film section and pour the dyeing permeation solution so that it reaches a depth of about 5mm relative to the long side. Allow a maximum of 5 seconds per side and visually check for the presence of channels while rotating to ensure the solution spreads to all sides. ・Method B: Edge Dip Method Fill a container with the dyeing permeation solution to a depth of about 3-6mm, dip each edge of the medical packaging, and quickly pull it out. Repeat this for each edge and visually check for the presence of channels. *Remove any unnecessary margins, such as those from chevrons, in advance. ・Method C: Eyedropper Method Open the unsealed margin areas of the transparent material and porous sheet on each edge, and using a dropper or similar tool, pour the dyeing permeation solution between them with the transparent sheet facing you. Repeat this for each edge and visually check for the presence of channels.
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For more details, please download the PDF document or feel free to contact us using the 'Contact Us' section below.
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Japan Business Logistics Co., Ltd. (JBL) operated as a 100% subsidiary of IBM Japan, Ltd. until 2007, but after the execution date of the stock transfer on January 4, 2008, we will embark on a new journey as an affiliated company of Yasuda Warehouse Co., Ltd. (YASDA). Together with all our employees, we hope to become the most trusted and reliable partner for our customers and business partners, based on the specialized skills and know-how we have cultivated in IBM-related businesses, to achieve an efficient and rapid supply chain. At the same time, we aim to create a corporate culture based on compassion and trust, and we are committed to actively meeting your expectations.