Lyophilized________ Preparation Record Lot Number:__________________

Start Date: __________ Time: __________ Operator: __________ Pharmacist: __________

Fill Volume PER vial:__________ Total Number of Vials: __________

Shelves Clean and Dry? __________ Condenser Drain Closed and Dry? __________

LOADING
Shelf Temp: _____ RTD#1 Temp: _____ RTD#2 Temp:_____ RTD#3 Temp: _____

FREEZING PROCESS

Start Date/Time _____ / _____ Completion Date / Time _____ / _____

Record temperatures at the end of freezing process

Shelf Temp: _____ RTD#1 Temp: _____ RTD#2 Temp:_____ RTD#3 Temp: _____

PRIMARY DRYING PROCESS (vacuum process)
Start Date/Time _____ / _____ Completion Date / Time _____ / _____
Time at -40C +/- 2C: _____________ Chamber Pressure: ____________

SECONDARY DRYING Increase shelf temperature to -35 C and record date and time that all preparations have reached -35 C +/- 2 C for no less than 30 minutes

-35C +/- 2C Shelf :_____ RTD#1: _____ RTD#2: _____ RTD#3: _____ Condenser Temp: _____ Pressure:_____ Init:_____
-30C +/- 2C Shelf :_____ RTD#1: _____ RTD#2: _____ RTD#3: _____ Condenser Temp: _____ Pressure:_____ Init:_____
-25C +/- 2C Shelf :_____ RTD#1: _____ RTD#2: _____ RTD#3: _____ Condenser Temp: _____ Pressure:_____ Init:_____
-20C +/- 2C Shelf :_____ RTD#1: _____ RTD#2: _____ RTD#3: _____ Condenser Temp: _____ Pressure:_____ Init:_____
-15C +/- 2C Shelf :_____ RTD#1: _____ RTD#2: _____ RTD#3: _____ Condenser Temp: _____ Pressure:_____ Init:_____
-10C +/- 2C Shelf :_____ RTD#1: _____ RTD#2: _____ RTD#3: _____ Condenser Temp: _____ Pressure:_____ Init:_____
-05C +/- 2C Shelf :_____ RTD#1: _____ RTD#2: _____ RTD#3: _____ Condenser Temp: _____ Pressure:_____ Init:_____
000C +/- 2C Shelf :_____ RTD#1: _____ RTD#2: _____ RTD#3: _____ Condenser Temp: _____ Pressure:_____ Init:_____
+05C +/- 2C Shelf :_____ RTD#1: _____ RTD#2: _____ RTD#3: _____ Condenser Temp: _____ Pressure:_____ Init:_____
+10C +/- 2C Shelf :_____ RTD#1: _____ RTD#2: _____ RTD#3: _____ Condenser Temp: _____ Pressure:_____ Init:_____
+15C +/- 2C Shelf :_____ RTD#1: _____ RTD#2: _____ RTD#3: _____ Condenser Temp: _____ Pressure:_____ Init:_____
+20C +/- 2C Shelf :_____ RTD#1: _____ RTD#2: _____ RTD#3: _____ Condenser Temp: _____ Pressure:_____ Init:_____
+25C +/- 2C Shelf :_____ RTD#1: _____ RTD#2: _____ RTD#3: _____ Condenser Temp: _____ Pressure:_____ Init:_____

STOPPERING
Date: __________ Time: __________ Chamber Pressure: __________ Init:_____

BACKFILLING
Date: __________ Time: __________ End Time: __________ Init:_____

UNLOADING SHELVES
Date: __________ Time: __________ Init:_____

Inspect all vials and note the number of broken: ___, number of improper closures: ___, and number of defective cakes: ___.
TOTAL Number of Finished Vials:_____ Comments (use other side if necessary):

Date: __________ Time: __________ Operator: __________ Pharmacist: __________