Testing the integrity of primary packaging using the PPA indicator leak test for tubes and stoppers
- 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.
- 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
- Depending on the requirements, the test can be carried out with unprinted or printed tubes
- Always check a complete shot of the tubing tool (i.e., all cavities) along with
the stoppers, which are intended for these tubes.
- Apply blue indicator fluid: water plus blue dye
- The tubes controlled with the stopper seal
- 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.
- Close the desiccator (put the lid on and align) and open the valve on the lid.
- Compressor: one
- If negative pressure -400 mbar is displayed on the manometer, then …
- Compressor: off
- Wait two minutes and then
- Open the desiccator
- Remove packaging
- Rinse packaging with clear water and then dry thoroughly (eg with compressed air) that they are clean and dry on the outside.
- For the packaging, tear off the guarantee ring and open it carefully.
- 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
(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)