“Sterilization of xxxxx Vials, Autoclave 6, Building 4”] Use Quantitative Criteria [“RSD Maximum of 4.5%” Rather Than “Must Demonstrate a Uniform Mix”] Use Meaningful Criteria [“3 Log Reduction in Endotoxin” Rather Than “8 Minutes At 300 C”] Validation as discussed in Q7A Should ...
through a 0.1 micron filter (note: we do not expect or require firms to routinely use 0.1 micron filters for media preparation). In the future, the firm will use sterile, irradiated TSB when it becomes available from a commercial supplier. (Firm...
through a 0.1 micron filter (note: we do not expect or require firms to routinely use 0.1 micron filters for media preparation). In the future, the firm will use sterile, irradiated TSB when it becomes available from a commercial supplier. (Firm's autoclave is too small to permit processin...
We think TOC or TC can be an acceptable method for monitoringresidues routinely and for cleaning validation. But in order for TOC to befunctionallysuitable, it should first be established that a substantial amount of thecontaminating material(s) is organic and contains carbon that can be oxidized...
“Sterilization of xxxxx Vials, Autoclave 6, Building 4”] Use Quantitative Criteria [“RSD Maximum of %” Rather Than “Must Demonstrate a Uniform Mix”] Use Meaningful Criteria [“3 Log Reduction in Endotoxin” Rather Than “8 Minutes At 300 C”] 性能合格确认 Validation as discussed in ...
(Firm's autoclave is too small to permit processing of TSB for media fills, so this was not a viable option.) The firm will continue monitoring for mycoplasma and has revalidated their cleaning procedure to verify its removal. In this case, a thorough investigation by the firm led to a ...
Since May 1991, CBER issued a number of memoranda to industry, depicting new recommendations, and modifications to previous guidance, in addition to guidelines on quality assurance and validation of computer systems. Although the agency, at the time of this publication, is in the process of ...
If a laboratory chooses to deviate from the product insert (eg, to offer a specimen type that is not described in the product insert), the modified assay is considered off-label use and the laboratory is obligated to perform a thorough validation to ensure that the modification does not ...
Sterilization and validation which is of course on par for all the devices and shelf life, protocols and testing. So when you show us the testing whether it be for bench, the clinical, animal or human factors, give us a summary table first where at a glance we can understand this it wh...
“Sterilization of xxxxx Vials, Autoclave 6, Building 4”] Use Quantitative Criteria [“RSD Maximum of 4.5%” Rather Than “Must Demonstrate a Uniform Mix”] Use Meaningful Criteria [“3 Log Reduction in Endotoxin” Rather Than “8 Minutes At 300 C”] Validation as discussed in Q7A Should ...