STERILIZATION CYCLES – AUTOCLAVE
ST — 109
STERILIZATION CYCLES – AUTOCLAVE
Temperature Used: 121 ºC Time to get F0 minimum 15
Time of Cycle: Validation minutes at coolest point for
(Theoretical Cycle Temperature) all loads
Various Loads of the Autoclave
1. MEMBRANE HOLDER AND VIAL FILLING ASSEMBLY LOAD
1. Membrane Filter Holder: 142/293 mm with 0.2µ membrane filter and 2 micron fiberglass prefilter
2. 10 Liters bubble test flasks 2 N0.
3. Vial filling machine unit: 10 ml/5ml glass syringes, stainless steel syringe casing, non-returned valves, filling needles, nitrogen manifold, SS ‘T’ joints, nitrogen gas reservoir.
Tubing
a. 2 Silicon tubing connecting outlets of solution holding vessel to the inlet of non-return valves
b. 2 Silicon tubing connecting outlets of non-return valve to the filling nozzles
c. 6 Silicon tubing to connect manifold to nitrogen gas nozzles
d. 1 Silicon tubing to connect nitrogen source to 25 mm filter
e. One PVC tubing for connecting two nitrogen filters
f. One Silicon tubing to connect manifold to nozzle of tank for gas overlaying
4. Sponges in bags.
5. SS bucket
6. 1 PVC tubing for drainage
7. Nitrogen filter holders: 25 mm with 0.2 micron hydrophobic membrane filter 4 Nos.
8. A bin containing tubing for filtration:
a) 1 silicon tubing for solution filtration
b) 2silicon tubing for nitrogen gas overlaying during filtration
c) 1silicon tubing to connect outlet of membrane holder to inlet of solution holding vessel.
9. 15 Liters distilled water in SS bucket.
10. Empty beakers 2 Nos.
11. 1 Liter round flat bottom B.T. flask
12. Tubing for integrity testing of nitrogen filters
a. 1 PVC tubing as an inlet to nitrogen filter
b. 1 silicon tubing at outlet of nitrogen filter
13. Air sampling drum and fan
14. Parchment papers 8 Nos.
15. Aluminum foil for covering distilled water flasks
16. Millipore breather filters 1 No.
As per validation cycle, the above load is run for 30 minutes from the time the digital temperature indicator reaches 123 ºC and in this time all the items including the item in coolest location satisfy F0 = 15 minutes.
2. Holding Vessel Load
Items sterilized in this load
1. 120 Liters holding vessel
2. 4 Nos. Pegs wrapped in a parchment paper
As per validation cycle, the above load is run for 30 minutes from the time the digital temperature indicator reaches 123 ºC and in this time all the locations including the coolest location satisfy F0 = 15 minutes.
3. GARMENT AND RUBBER STOPPER LOAD
Items sterilized in this load
1. 10 Sets of garments placed in perforated baskets
2. Cotton buds for swab testing
3. Rubber stoppers (approx. 30,000) in maximum 9 large and 6 small SS pots.
As per validation cycle, the above load is run for 60 minutes from the time the digital temperature indicator reaches 123 ºC and in this time all the items including the item in the coolest location satisfy F0 = 15 minutes.
4. MEMBRANE, HOLDER, HOLDING VESSEL AND AMPOULE FILLING ASSEMBLY LOAD
Items sterilized in this Load.
1. 40 liters holding vessel
2. Membrane filter holder: 142/293 mm with 0.2µ membrane filter and 2 micron fiberglass prefilter.
3. 10 liters bubble test flask 2 Nos.
4. Ampoule filling machine unit: Ss syringes along with SS spring, filling needles, nitrogen needles, nitrogen manifold, SS‘T’ joints.
Tubing:
a. 7 silicon tubing for nitrogen line
b. 6 silicon tubing for nitrogen line
c. 8 silicon tubing for pre and post nitrogen flushing
d. 4 silicon tubing for filling of solution
5. Sponges in bag.
6. SS bucket 2 Nos.
7. 1 PVC tubing for drainage
8. Nitrogen filter holders: 25 mm with 0.2µ hydrophobic membrane filters 4 Nos.
9. A bin containing tubing for filtration:
a. 1 silicon/PVC tubing for solution filtration
b. 2 silicon tubing for nitrogen gas overlaying during filtration
c. 1 silicon tubing to connect outlet of membrane holder to inlet of solution holding vessel
10. Empty beakers 2 Nos.
11. 1 Liter round flat bottom B.T. flask
12. Tubing for integrity testing of nitrogen filters.
a. 1 PVC tubing as an inlet to nitrogen
b. 1 silicon tubing at outlet of nitrogen filter
13. Air sampling drum and fan
14. Parchment papers 8 Nos.
15. Aluminum foil for covering distilled water flask
As per validation cycle, the above load in run for 15 minutes from the time the digital temperature indicator reaches 123 ºC and in this time all the items including the items in coolest location satisfy F0 = 15 minutes.
5. EMPTY ALUMINUM CONTAINER LOAD
Items Sterilized in this Load
1. 4Nos. of empty aluminum containers for collection of filled ampoules.
As per validation cycle, the above load id run for 15 minutes from the time the time the digital temperature indicator reaches 123 ºC and in this time all the location including the coolest location satisfy F0 = 15 minutes.
6. GARMENT LOAD
Items sterilized in this load
1. 10 sets of garments placed in perforated baskets
2. Cotton buds for swab testing
As per validation cycle, the above load is run for 60 minutes from the time the digital temperature indicator reaches 123 ºC and in this time all the location including the coolest location satisfy F0 = 15 minutes.
TALIBAN 