Fibre in Injectable in Pharmaceutical industry l Fibre in vials of sterile product visual inspection in pharma company.
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Fibre in Injectable in Pharmaceutical industry l Fibre in vials of sterile product visual inspection in pharma company.
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Questions covered:
Q. What is fibre in injectable / sterile products?
Q. What are the main sources fibre in injectable ?
Q. Fibre in injectable are avoidable or can be controlled ?
Q. Whether filtration with 0.22 micron filtration can remove fibres in injectable?
Q. What is impact of fibre on injectable / sterile products ?
Q. What cleanroom controls and personnel gowning controls can be implemented to control fiber in injectable?
Q. What raw material and equipment controls can help to minimize fibre in injectable?
Q. What cleaning practices and environmental monitoring controls can minimize fibre particles?
Q. How to differentiate glass particle and fibre particle during manual visual inspection of injectables. it is very difficult to differentiate between them as both are white or transparent?
Q. What guidance given in USP - 788 - Particulate Matter in Injections for fibre particles?
Q. What EU GMP Annex 1 Manufacture of Sterile Medicinal Products 2022) guide about gowns used in pharmaceutical industry ?
Q. USP - 790 - Visible Particulates in Injections guide about fibre particles?
Q. What EU GMP Annex 1 - 2022 guide about fibre in injectable ?
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