Detecting Seal Leaks In Porous Medical Packaging By Dye Penetration
[Gözenekli Tıbbi Ambalajlardaki Mühür Sızıntılarının Boya Penetrasyonuyla Tespiti]
EPTIS factsheet 1130744 | Last revision 2024-07-19 | URL: https://www.eptis.bam.de/pts1130744 https://www.eptis.bam.de/pts1130744
| PT provider | |||||||
| PT provider | AYA Validasyon Ambalaj Sterilizasyon A.Ş. AYA Validasyon Ambalaj Sterilizasyon A.Ş. | ||||||
| Based in | Turkey | ||||||
| Language(s) | English | ||||||
| Remarks | This study has been specifically crafted for laboratories engaged in the testing of packaging materials utilized in medical devices. Participation in this study is facilitated through adherence to ASTM F1929 and equivalent standards. The reporting format will entail the documentation of observations as either "Leak observed" or "No leak observed." Each participant will receive a total of five packages, some of which may be sealed incorrectly. Consequently, participants are required to report any observed leakage on only one side of the packages. It is expected that participants accurately identify both leaked and non-leaked packages in accordance with the provided criteria. | ||||||
| Keywords | |||||||
| Product groups |
Package for goods distribution
Health care / medical devices Plastics Pulp and paper |
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| Testing fields |
Materials evaluation
Medical analysis |
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| Technical details | |||||||
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| Aims of the PT scheme | |||||||
| Target group of participants | Laboratories that perform tests on medical device packages | ||||||
| Linked to specific legislation / standards | ASTM F1929 ASTM F2096 ASTM F88/F88M | ||||||
| Additional, subsidiary aims | - | ||||||
| Number of participants | 7 | ||||||
| Accredited or otherwise reviewed by a 3rd party |
Accredited by Will be applied for the ISO 17043 after 1st organization. on the basis of - |
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| Operation is commissioned / requested by | No | ||||||
| Fees and frequency | |||||||
| Participation fee | 250 € (plus shipment), 5 samples per applicant. | ||||||
| Regularly operated | No (last time in 2023) | ||||||
| When will be the next round | 2024 | ||||||
| Contact details of the PT provider | |||||||
| Provider | Contact person | ||||||
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AYA Validasyon Ambalaj Sterilizasyon A.Ş.
Saray Mah. 106. Cad. No: 14 A Blok Kahramankazan Turkey Phone: 05336546690 Fax: Web: https://ayalab.com.tr/ https://ayalab.com.tr/ |
Erdem Savaş
Phone: Fax: Email: e.savas@ayalab.com.tr e.savas@ayalab.com.tr |
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