RE: Cleaning validation samples for API Contribution from dick bonner written on 10/14/2003 at 17:20
Original contribution: Cleaning validation samples for API written by umesh B.G on 9/23/2003 at 11:11) Swab sample are usually taken with a sterile cotton wool on a stick. Wipe the cotton-wool stick over a 4inch square area of the reactor, carefully identifying exactly where the swab was taken, and why that place was chosen ( eg Hot-Spot). The swab may have had to be wetted in some solubilizing solution or solvent first. The whole process and recovery of the API onto the swab needs to be validtated as does the elution of the API and the test method as well. The surface area of the reactor and pipework can then be calculated and the total API present is then a factor of the total area in square inches divided by 4 ( the swab area) multiplied by and analytical recovery factor multiplied by the analytical result. Answers to this contribution:
Answering this Contribution:
|
