Closed loop sterility testing systems have been successful in prevention of false positives while sterility testing of sterile injectables. However, there are special containers such as insulin cartridges (that fit into hand held delivery systems), wherein increased manual intervention is required for pooling the same into a 100ml vial before these can be transferred/filtered through the closed sterility test canisters. This increases the possibility of extraneous contamination and thereby false positives.
A syringe is used to draw the insulin sample from the specialized cartridge and is then pooled into a 100ml vial to be transferred/filtered through the sterility test canisters.
This involves multiple risks and cons such as:
- Chances of extraneous contamination, spillage and manual error
- Increased incidence of false positives
- Increased cost of operation and documentation
Continue reading “Prevent False Positives While Sterility Testing of Insulin Cartridges”
Clarification of turbid solutions is a key requirement to achieve critical objectives in the pharmaceutical and bio-pharmaceutical manufacturing which range from clarification, polishing, bio-burden reduction to sterilization of process fluids.
These process streams can range from easy to filter, predictable solutions such as large volume parenteral, water for injection and buffers, to difficult to filter colloidal solutions, emulsions, liposomal drug delivery systems, cell cultures, lysates, plasma, etc.
0.2 µm Membrane filters are used at various stages of the manufacturing process and fluids with a wide ranging contamination profile, including difficult to filter colloids and compressible particles, pose a serious challenge to these filters. This leads to lower throughputs and higher filtration footprint.
Continue reading “ClariPro GK – A Success Story”