Ensuring the Integrity of Pharmaceutical Packaging

How a pharmaceutical manufacturer can ensure and verify the integrity of packaging: There are several proven test methods for Container Closure Integrity Testing (CCIT) to choose from here.

The risk: The ingress of impurities

Regardless of whether the packaging is glass bottles, ampoules, blisters or even IV bags: a tight and reliable seal is essential when it comes to primary packaging for medical products. There are various reasons for this. With many medicines, the penetration of moisture or oxygen must be prevented in order to ensure their efficacy over the entire shelf life. And in the case of sterile parenteral products, biological contamination poses a serious risk of infection for the patient.

Test methods: The user has the choice

But which method is suitable? One thing is certain: there is no single solution that fits all the challenges associated with a particular product or project. So the user has to choose which methods come into question and which criteria the user should apply when making a decision. There are – from Pfeiffer Vacuum's point of view – several suitable methods: Helium Mass Spectrometry, Mass Extraction, Optical Emission Spectroscopy.

High performance CCIT solution for the pharmaceutical industry based on helium mass spectrometry

Due to the method’s popularity, many standard helium leak detection systems exist on the market.

The ASM 2000 from Pfeiffer Vacuum is a comprehensive solution completely adapted to the needs of pharmaceutical companies.

It is the perfect solution for the validation and qualification of new containers. Based on a high performance helium mass spectrometer leak detector, it also includes a helium charging module, and can be equipped with custom fixtures for the particular container formats. The instrument is calibrated against NIST-traceable standard leaks. Further advantages of the ASM 2000 are its high helium pumping, its integrated automatic helium charging module as well as the optimized free internal volumes. Those features guarantee high performance measurements on helium filled sealed containers and open sub-assemblies. The ASM 2000 sustains very high throughput, ensures the accuracy and the reproducibility of the measurement results, and allows ultra fast cycle time.

The user has the choice – but help is to hand

There are several proven and purposeful methods available. Pfeiffer Vacuum supports the user during the entire CCIT process definition and integration process and also throughout the GMP procedure (IQ/OQ), including the required documentation. In its pharmaceutical laboratories, Pfeiffer Vacuum also conducts extensive feasibility studies and acquires in-depth process knowledge for the user.

Find out more about this and the other solutions from Pfeiffer Vacuum and explore the virtual CCIT showroom.