Pharmaceutical CCIT Positive Controls Vial Ampoule PFS BFS
About Zillion
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Zillion CCIT is the leading pharmaceutical packaging leak testing solution provider since 2005. The main business ranges from CCIT testing services, generic drug conformance assessment, packaging sealing verification, packaging headspace analysis, equipment 3Q verification services, equipment method verification services, CCIT feasibility study services, covering the entire life cycle of drug production. CCIT application and research, etc. Detection methods cover various CCIT methods, including vacuum decay method, laser method, micro-current high-voltage discharge method, vacuum helium detection method, low-voltage discharge method, etc.
Quality Assurance
Zillion CCIT is the leading container closure integrity testing solution provider in pharmacy area
NEWS
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Cryogenic refrigeration of biological products throughout their life cycle——Package seal integrity test solution
Why do biological products leak at low temperatures? Biological products such as live viruses, vaccines, cells and so on usually need to be stored in low temperature or even ultra-low temperature environment. The physical and chemical properties of many packaging components of biological products pa2023-01-06
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HVLD(Low voltage) methods for CCIT(container closure integrity testing)
‘No one test is appropriate for all packages or for all leak testing applications’ (USP <1207, FDA presentations and rticles),?A?‘toolbox’ of CCI test methods should be standard configuration for the big pharmaceutical company who need to meet the international market or CDMO company need to face di2023-01-06
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Language for Container Closure Integrity requirements in EU New Annex 1:(deadline for implementation 25 August 2023)
Global regulators are paying more and more attention to improving practices that assure good Container Closure Integrity of sterile products . l?USP<1207> Chapter ’Package integrity evaluation-sterile products’?implemented in August 2016 (old 2 pages chapter now 50+ pages) l?CDE ‘Technical Guide for2023-01-06
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Positive Control Comparision
Positive control types-Laser drilling, Micropipette, Capillary, Natural defects.2023-01-06
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CCIT Methods Comparision -Vacuum decay, HVLD, Laser method, Microbial ingress method, Dying method
Advantage and disadvantage of Container closure integrity testing methods-Vacuum decay, HVLD, Laser method, Microbial ingress method, Dying method2023-01-06
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Gusu dialogue - "the application of drug packaging integrity under the new rules" forum hold in Suzou by Zillion CCIT
How to choose the sealing integrity evaluation method for injection product packaging system? What problems should be paid attention to in the application of integrity technology of drug packaging and sealing? How are CCIT container seal integrity positive samples applied on various packaging materials?2022-01-20
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Zillion’s exhibition in the third China International Biological and Chemical Pharmaceutical Industry Conference
Zillion’s exhibition in the third China International Biological and Chemical Pharmaceutical Industry Conference2022-01-20
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Container Closure Integrity Testing
When assuring the quality of all packaged products, testing container closure integrity (CCI) is critical, especially as related to parenteral pharmaceuticals. If there is a breach of the seal, even a microscopic one, it affects the sterility and the stability of the product – the drug may not be as effective due to oxidation or moisture ingress impacting the active ingredient.2022-01-20
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New Guidelines Offer Menu Of Standard Sterile Package Tests
The dye ingress test method continues to be a widely used test method for Container Closure Integrity (CCI) within the pharmaceutical industry. For high risk parenteral applications this method is not a suitable approach due to reliability of the method and measure.2022-01-20
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Industry Survey: Best Practices In Container Closure Integrity Testing
Container closure integrity (CCI) plays an important role in maintaining the sterility and stability of sterile injectable products. New regulatory guidance has recently triggered changes in industry best practices in the area of CCI testing (CCIT). This article summarizes the answers to polling questions that were presented to representatives of pharmaceutical companies involved in CCIT activities.2022-01-20
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Zillion CCIT is the leading pharmaceutical packaging leak testing solution provider since 2005. The main business ranges from CCIT testing services, generic drug conformance assessment, packaging sealing verification, packaging headspace analysis