Pharma industry

Leak testing or “container closure integrity testing” (CCIT) plays an important part to secure sterility over the shelf life of a product and prevent microbiological, oxygen or moisture ingress into the primary packaging as for example vials, syringes, plastic bottles or pouches.

Various pharmaceutical packaging

Various pharmaceutical packaging

Various pharmaceutical packaging

Various pharmaceutical packaging
 

Historically, probabilistic test methods like blue dye or microbiological ingress testing have been mainly used in the industry. Nowadays, those methods are being replaced by deterministic methods which reduce the needs for sample preparation and validation, and also give more reliable detection of leaks and defects.

Another characteristic of the pharma industry is that the integrity requirements are often not defined in leak respectively flow rates but as maximum defect size in µm.

Regulations play a major role in the pharma industry. While many regulations like the “European Pharmacopoeia” only talk about the fact that integrity testing needs to ensure “sterility over the shelf life of the product”, PDA’s USP 1207 gives quite detailed recommendations about CCIT in the pharma industry. CCIT at different stages as MALL (maximum allowable leak level) testing, 100 % production testing and IPC (In Process Control) are also described.

Key challenges

As already mentioned above, there are quite strict regulations in place in the pharma industry that also describe different process stages of the development and production process. All those stages thereby show very different requirements when it comes to leak testing. During the development process, integrity testing must ensure that the packaging is capable of securing an integrity of lower 6 · 10-6 mbar · l/s (<1 µm maximum defect size) by design. Therefore, helium leak testing is the method of choice.

While generally the MALL leak rate requirement should be met with every produced packaging, practical reasons lead to the fact that during production 100% testing is often performed with less sensitive test methods. In this case, cycle time for very high production rates becomes more critical. Typical detection limits here are between 5-10 µm.

Due to the fact that a sensitive enough measurement is hard or impossible to reach, IPC is performed on production samples with more sensitive testing technologies additionally to the 100 % testing. Here the test sensitivities are often between 1 and 5 µm.

  • Highly sensitive helium leak testing for MALL testing during production – accuracy, sensitivity, safety
  • Reliable and high speed integrity testing for 100 % production – short cycle times and reliable measurement
  • Reliable and quantitative measurement with high sensitivity for IPC testing – repeatability and reliability with easy test handling

Pfeiffer Vacuum solutions

Pfeiffer Vacuum helium leak detection solutions are perfect for MALL testing in the pharmaceutical industry. In order to ensure a correct measurement, it is very important that you also manage the tracer gas concentration during the measurement. This is especially tricky when handling vials or other sealed packages. Therefore, Pfeiffer Vacuum offers complete solutions including tracer gas handling and charging, as well as adaptations for your packaging and test chambers.

ASM 2000
ASM 2000
 

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Which tracer gas?

For production testing, especially when 100 % control is required, cycle time becomes more critical. But also ensuring that the complete packaging is tested and that the drug itself is not affected by the test are crucial.

With our mass extraction product range, we offered solutions for 100% testing of IV bags with through puts of 80 parts per minute.

Test station customer solution
Test station customer solution
 

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Mass Extraction (vacuum testing)

For IPC, Pfeiffer Vacuum offers various solutions to fit different packaging types and different kinds of drugs that are inside the packaging – mainly differing between liquid and solid fillings. Depending on the application, we offer our mass extraction or AMI (optical emission spectroscopy) solutions. Beside the high sensitivity of the products, the technologies ensure reliable and operator independent measurement with quantitative results.

Test station ATC
Test station ATC
 

Read more:
Mass Extraction (vacuum testing)

Read more:
Optical emission spectroscopy

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