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Annex 1 and the Closed Container Integrity Test (CCI)
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Integrity Test Equipment of Closed Containers in accordance with Annex 1
written by Jesse Sklar, STEQ America LLC.
This white paper covers how Bonfiglioli Engineering (BE) test equipment helps sterile product manufacturers comply with the new EU Annex 1 packaging guidelines for the integrity of closed containers (CCI).
With over 50 years of experience, BE stands out as one of the most experienced container testing companies in the world. Let’s look at each of the five points in Annex 1 that cover the integrity of closed containers (CCI) and associate them with the BE systems that will address them:
1) Annex 1, 8.21 – Final containers must be closed by duly validated methods
BE’s core offerings include both off-line testing for the laboratory and 100% leak testing systems for vacuum decay leak testing (VDT), pressure decay leak testing (PDT) or free space gas analysis (HGA) for a wide range of rigid and flexible pharmaceutical vessels, which comply with ASTM methods, Annex 1 guidelines and UPS’s preferred deterministic test methods. With more than 50 years of experience in CCI testing, Bonfiglioli has thousands of validated systems in operation around the world.
For offline testing
• LT Pro is BE’s benchtop lab system for VDT or PDT testing of containers.
• The Laser Pro is BE’s benchtop HGA for containers.
Both systems offer highly sensitive and accurate quantitative test results. VDT and HGC are completely non-destructive, and PDT is non-destructive for non-leaking samples.
To test 100% of your production
• BE’s PK Series offers vacuum decay or pressure decay leak testing for many different types of containers, including vials, syringes, cartridges, BFS, and IV pouches, and sachet packaging.
• The LVA600 enables 100% laser-based gas analysis typically used for freeze-dried vials to check the internal pressure in the container; or in any case where you need to check that a layer of nitrogen-free space is being kept in a container and that there is oxygen ingress.
In addition, BE offers semi-automatic machines for those cases where you have smaller productions/batches. A benchtop system can be very slow and a fully automatic system is “too much” system to use for these smaller batch sizes.
2) Annex 1, 8.22 – Where final containers are closed by fusion
Our PK-VS and PK-VF systems are ideal for inspecting 100% of BFS containers and SVP bags, ensuring total integrity.
These systems effectively respond to the challenge of meeting the new Annex 1 requirements for 100% CCI for smaller melt-sealed containers.
3) Annex 1, 8.23 – Samples of products using different melting systems
BE’s benchtop and semi-automatic CCI test systems are great options for handling SPC container testing, while if desired, 100% testing can be performed on containers without a melt seal as well. The LT Pro and Laser Pro systems are directly scalable to BE’s 100% inspection systems. In other words, the technologies and testing methodologies for the benchtop units match those of the 100% online systems.
4) Annex 1, 8.24 – Vacuum-sealed containers shall be tested
BE can offer the Laser Pro system for SPC testing or the LVA600 for 100% testing to verify the vacuum level. In addition, VDT can be used to check if a vacuum has been lost.
(5) Annex 1, 8.25
Validating the integrity of the container closure should take into account any shipping or shipping requirements that may negatively impact the integrity of the container (e.g., by decompression or extreme temperatures).
BE’s HGA systems will detect any changes in the oxygen level or pressure (humidity) in a container with free space, and BE’s VDT or PDT systems can be used in containers without free space to check for leaks by determining a container leak rate that corresponds to a micron hole size.
In addition to all the systems mentioned above, BE offers multiple combination systems to include different test methodologies in one space-saving platform:
• Automated visual inspection (AVI) and VDT or PDT
• AVI and HGA
• AVI and VDT or PDT, plus HGA
Click here and access the article on our LinkedIn as well!
For more information about BE’s line of equipment, contact our experts through contato@steq.com.br. [/vc_column_text][/vc_column][/vc_row]
