FCE:

SUP SID:

Aseptic Filler:

 Critical Control Sterilizing Record

 Number Control/Description Unit Limit Threshold Corrective Action
Point Medium Used
1 Compressed Air
Filter            
Sterilization
1.2 Sterilization
           
Temperature
2 Aseptic chamber
           
pre-heat
2.1 Pre-heat
           
Temperature
2.2 Pre-heat Time            
3 Aseptic Chamber
Sterilization
3.1 Sterilization
Temperature
3.2 Sterilization
Time
3.3 H202
Concentration
3.4 Sterile air
overpressure
4 Production
4.1 Air Knife
Temperature
4.2 H202 Bath
Temperature
4.3 H202
Concentration
4.4 Film Speed
4.5 Sterile air
overpressure
 

Product Sterilizer:

 Critical Control Sterilizing Record

 Number Control/Description Unit Limit Threshold Corrective Action
Point Medium Used
1 Product Sterilizer            
1.1 Sterilization
           
Temperature
1.2 Sterilization
           
Time
1.3 Sterilization
           
Back Pressure
2 Aseptic Tank            
2.1 Sterilization
Temperature
2.2 Sterilization
Time
2.3 Sterilization
Back Pressure