PPA indicator leak test

Testing by PPA indicator leak test

Testing the integrity of primary packaging using the PPA indicator leak test for tubes and stoppers

Aim
  • The integrity of the primary package as a whole (tube and plug) is a prerequisite for maintaining product quality.
  • To test the integrity, a leak test method using a blue indicator fluid, which provides information about the packaging components in terms of composition / dimension and sealing variables with regard to time, temperature and pressure.
testing schedule
  • Tool qualification (new tool or dimensionally modified tool)
  • Sampling at the beginning and at the end of the intended durability (long-term test)
  • Significant material or manufacturing changes
test preparation
  1. Depending on the requirements, the test can be carried out with unprinted or printed tubes
  2. Always check a complete shot of the tubing tool (i.e., all cavities) along with
    the stoppers, which are intended for these tubes.
  3. Apply blue indicator fluid: water plus blue dye
  4. The tubes controlled with the stopper seal
  5. Insert the sealed tubes into the blue indicator fluid of the desiccator and weigh them down that the packaging is completely immersed in the blue indicator fluid.
  6. Close the desiccator (put the lid on and align) and open the valve on the lid.
  7. Compressor: one
  8. If negative pressure -400 mbar is displayed on the manometer, then …
  9. Compressor: off
  10. Wait two minutes and then
  11. Open the desiccator
  12. Remove packaging
  13. Rinse packaging with clear water and then dry thoroughly (eg with compressed air) that they are clean and dry on the outside.
  14. For the packaging, tear off the guarantee ring and open it carefully.
  15. Visually inspect the inside of the tubes:
    • In the case of blue traces, the packaging material was leaking: Inform the manager of the QA and clarify the further procedure.
    • If no blue traces are visible, the packaging was tight.
Foundations for experimental setup
There are no clear guidelines for the be predefined vacuum in mbar, and the holding time of vacuum in the literature currently.
A reference value refers to the transport of the packaging material by plane, wherein in 20,000 feet above sea level, a vacuum pressure of 400mbar to be expected. (1)

Literatur:
(1) http://www.packtest.com/archives/106, abgerufen am 03.05.2017
(2) American Society for Testing and Materials – ASTM 6653 „Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method“
(3) T.Krebsbach, C.Schröder, C.Matthies, „Container Closure Integrity Test“, Pharm.Ind.76, Nr.7, 1141-1147 (2014), Editio Cantor Verlag, Aulendorf (Germany)