Validation is the process of establishing documentary evidence demonstrating that a procedure,process or activity carried out in testing and then production maintains.
VALIDATION SCOPE :-
Autoclave (Vertical / Horizontal)
Bung Processor
Dry Heat Sterilizer
Sterilization Tunnel
● Validation Will Be Carried Out With 16 Channel Software Based PC Interface Data Logger 21 CFR Part11 Compliance.
● Validation Report Will Be Include Pass Criteria, Procedure, Drawing, Min./ Max./Average ForEachPointTemperature, Graph, Lethal Rate & F0 and FH Value Calculation, Hot Point, Cold Point AndConclusion.