1. Catalogs
  2. Labthink Instruments Co., Ltd.
  3. Leak Detection Tests for Ensuring Medical Device Package Integrity

Leak Detection Tests for Ensuring Medical Device Package Integrity
1 /3Pages

Leak Detection Tests for Ensuring Medical Device Package Integrity

Leak Detection Tests for Ensuring Medical Device Package Integrity
1 /3Pages

Catalog excerpts

Leak Detection Tests for Ensuring Medical Device Package Integrity-1

Labthink Instruments Co., Ltd. [email protected] +86-531-85068566 Leak Detection Tests for Ensuring Medical Device Package Integrity Keywords: Medical packaging integrity, leak testing, bubble method, vacuum method, ASTM standards. Medical devices rely on sterile packaging to ensure patient safety. Leakage can compromise sterility, so manufacturers rigorously test package integrity. This article explores two key methods for leak detection: the bubble method and the vacuum method. The bubble method (ASTM F2096) works by pressurizing the sealed package underwater. If leaks exist, escaping air forms a stream of bubbles, revealing the breach. This method is versatile, handling various package shapes and sizes. However, pressure control is critical. Too little pressure might miss leaks, while too much can damage the packaging or create misleading bubble patterns for porous materials. The key is to find the right balance, starting with a quick initial pressure increase followed by a slower, controlled rise until a steady stream of bubbles appears.

 Open the catalog to page 1
Leak Detection Tests for Ensuring Medical Device Package Integrity-2

Labthink Instruments Co., Ltd. [email protected] +86-531-85068566 C660B Leak and Seal Strength Tester is professionally designed for the leakage tests of packages for food, drugs, medical instruments, household chemical products, cars, electronic components, stationeries and other industrial products. The instrument also can be used to test seal performance of specimens after falling and compression tests Vacuum Degree Vacuum Chamber Effective Sizes

 Open the catalog to page 2
Leak Detection Tests for Ensuring Medical Device Package Integrity-3

Labthink Instruments Co., Ltd. [email protected] +86-531-85068566 The vacuum method (ASTM D3078) takes a different approach. The sealed package is submerged in a liquid-filled container placed within a vacuum chamber. As the pressure inside the chamber decreases, leaks allow air or liquid to enter the package, creating visible bubbles or liquid ingress. The higher the vacuum level, the smaller the leaks it can detect. However, this method has limitations. Flexible packaging with excess headspace can affect test accuracy. Additionally, trapped air pockets might mimic leaks, requiring careful observation....

 Open the catalog to page 3

All Labthink Instruments Co., Ltd. catalogs and technical brochures

  1. C610M

    3  Pages

  2. C690H

    4  Pages

  3. C130H

    4  Pages

  4. COF-P01

    2  Pages

  5. VAC-V2

    3  Pages

  6. C230H (2025)

    4  Pages

  7. C610H

    3  Pages

  8. C206H

    4  Pages

  9. C406H

    5  Pages

  10. C403H

    5  Pages

  11. C 681M

    1  Page

  12. C660B (2025)

    3  Pages

  13. C632M

    3  Pages

  14. C630H

    3  Pages

  15. C620H

    3  Pages

  16. C 640

    4  Pages

  17. C 660M

    3  Pages

  18. C306H (2025)

    4  Pages

  19. C203H

    4  Pages

  20. BTY-B3P

    2  Pages

  21. C360M

    4  Pages

  22. C632B

    3  Pages

  23. C190H

    3  Pages

  24. C390H

    4  Pages

  25. C360H

    4  Pages

  26. C660M

    3  Pages

  27. C303H

    4  Pages

  28. C106H

    5  Pages

  29. C640

    4  Pages

  30. MXD-02

    2  Pages

  31. CHY-C2A

    2  Pages

  32. C611B

    2  Pages

  33. CH130

    4  Pages

  34. C 631 H

    2  Pages

  35. C660 B

    3  Pages

  36. VAC-VBS

    3  Pages

  37. XYD-15K

    2  Pages

  38. C360

    4  Pages

  39. C631 H

    2  Pages

  40. FST-02

    2  Pages

  41. C681 M

    2  Pages

  42. C230

    4  Pages

  43. C631H

    2  Pages

  44. C612M

    3  Pages

  45. SLY-SI

    2  Pages

  46. C360 M

    4  Pages

  47. C611M

    2  Pages

  48. C330H

    4  Pages

  49. Leak Tester

    3  Pages

  50. Tensile Testers

    19  Pages

  51. FDI-01

    5  Pages

  52. DIN 75201

    2  Pages

  53. Abrasion Test

    2  Pages

  54. Torque Meter

    2  Pages

  55. Leak Detector

    2  Pages

  56. Torque tester

    2  Pages

  57. Impact tester

    2  Pages

  58. Gas Analyzer

    2  Pages

  59. TOQUE TESTER

    1  Page

Archived catalogs

  1. C611M

    2  Pages

  2. C306H

    3  Pages

  3. C230H

    4  Pages

  4. Leak Tester

    2  Pages

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.