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Container Closure Integrity

Container Closure Integrity Testing (CCIT)

cci-pharma

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.

Key benefits

Product safety is patient safety
The pharmaceutical container should keep contents in and bacteria or other contaminants out. Use our CCIT solutions to test if each single container is free of leaks and if other quality attributes like headspace oxygen level comply
The appropriate technology for your product
We offer laboratory and consulting services that support you in selecting and developing the right method for each product and container before the start of the machine project. After installation, we offer method validation tailored to your application
Improve production processes
The generation of scientific and analytical data supports you in gaining knowledge and improving your upstream processes

Container closure integrity testing methods and machines for your product

Laser-based headspace analysis with KHS

Optical measurement of absolute pressure, oxygen or CO2 to detect permanent and temporary leaks.

CCIT-2

High-voltage leak detection (HVLD) on KLD

Reliable leak testing of aqueous solutions.

High-voltage leak detection module integrated on AIM3 or AIM296 plus

CCIT integrated in visual inspection machine.

CCIT-4

High-voltage leak detection module integrated on AIM3 or AIM296 plus

CCIT integrated in visual inspection machine

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:

  • Compact platform for 100% CCI testing covering a large format range (2R to 250 ml)
  • High detection and low false rejects rate through automatic calibration, re-inspection and separate eject for too dirty containers (optional)
  • Retrofit of HSA modules, formats and products possible

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Expert Services
Expert Services

We support you throughout the entire machine life cycle, from spare parts management to digital line optimization. Service agreements are a key element of our portfolio structure. Together, we tailor our solutions to your individual needs. Our global network of experts supports you with maintenance planning, technical support, and modernizations, as well as operator training and end of life services. With our digital solutions, you gain control over your production processes and create transparency on product and machine data anytime, anywhere.

Maintenance & Support
Maintenance & Support

Spare Parts
Spare Parts

Why choose a Syntegon container closure integrity solution?

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About us


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. 

years of experience 
patents and patent applications 
machines installed world-wide 
locations 
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Our expertise, your advantage

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.

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Our expertise, your advantage

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. 

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Our expertise, your advantage

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!

Downloads

KHS Series
KHS Series

Laser-based Headspace Analysis Machine

KLD 1043
KLD 1043

High voltage leak detection machine

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