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2023-01-06
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 pa
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2023-01-06
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 di
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2023-01-06
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 for
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2023-01-06
Positive Control Comparision
Positive control types-Laser drilling, Micropipette, Capillary, Natural defects.
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2023-01-06
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 method
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2022-01-20
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?
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