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Container Closure Integrity Testing (CCIT) through the product life cycle has been gaining importance in the pharmaceutical industry for several years. Container Closure Integrity is an important factor to maintain sterility and stability of the drug product inside the containers. Automated machines provide an effective way to non-destructively test 100% of all units even of large batches to ensure final product quality.
Optical measurement of absolute pressure, oxygen or CO2 to detect permanent and temporary leaks.
Reliable leak testing of aqueous solutions.
CCIT integrated in visual inspection machine.
CCIT integrated in visual inspection machine
Thanks to our long-standing inspection expertise, we offer state-of-the-art visual inspection technologies for manual, semi- and fully automated operations as well as Container Closure Integrity testing solutions.
Laser-based headspace analysis (HSA) measures light absorption by oxygen and/or water vapor molecules and rejects containers with elevated oxygen, pressure or moisture levels. The non-destructive and rapid optical method is perfectly suited to test each container even of large batches. It helps to reliably detect temporary or permanent leaks. The KHS series is based on the highest Syntegon quality standards with HSA technology inside from Lighthouse Instruments. Flexible, modular and user-friendly design ensures optimal accessibility and maintenance.
Benefits:
With the KLD series, Syntegon continues its long history as a leading manufacturer of leak detection machines (dating back to the mid 80s!). The latest generation features even more precise measurement, data acquisition and recipe setup tools, gentle container transport and outstanding ease of handling and maintenance. The fast and reliable technology used in the KLD series ensures 100 % container closure integrity testing (CCIT) by applying high AC voltages (up to 30 kV) and detecting leaks by elevated current responses.
Benefits:
Visual and CCIT inspection methods are increasingly used in a complementary manner to achieve even higher product quality, encouraged e.g. by the new EU GMP Annex 1 (Draft 2020). Syntegon offers machine platforms that combine both quality safeguards in one machine: the AIM 3000 series, the AIM 296 plus series and the DIR syringe inspection line.
Benefits:
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Syntegon supports you in selecting the appropriate testing method individually for each drug product and container type. A thorough understanding of the application is paramount: What is the maximum allowable leak limit (MALL)? How is the leakage behavior related to storage conditions and other process parameters? What are the drug product properties, like conductivity or oxygen sensitivity? We are happy to consult you to find the perfect match - assisted by sample test studies where needed.
Customers from around the globe rely on our Container Closure Integrity testing expertise.
We have supported some of the most renowned industry players in boosting their efficiency, expanding operations or upgrading their equipment to meet latest manufacturing standards.
“We were able to systematically identify and adapt crucial sections within our filling and sealing processes, to make them more stable and reduce the number of unnecessary rejects even further. In fact, our performance is increasing from week to week.”
- Philippe Truelle, CEO of CDM Lavoisier
CDM Lavoisier decided to change their inspection processes for no less than 30 products in four different packaging formats. They are now all inspected on the vision+CCIT machine AIM 3311 from Syntegon.
We are proud to support the fight against Covid-19 together with our partners, some of the biggest contract manufacturers and multinational pharma companies worldwide.
The Covid-19 pandemic is challenging manufacturers of medicines: They have to respond fast to changing demands and supply key medicines across borders. Simultaneously, the preparation for new vaccines and therapeutics is ongoing. We are keeping up with our mission!
Laser-based Headspace Analysis Machine
High voltage leak detection machine
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