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Load Pattern & Justification for steam steriliser

APPROVAL SIGNATURES

Signing of this approval page of load pattern indicates agreement with the qualification approach described in PQ protocol. If any modification in the load pattern becomes necessary, a revision through change control shall be prepared, checked and approved. Wherever applicable revalidation of the modified load pattern shall be carried out.

  1. Location of the Bowie – Dick Test Pack 

Schematic representation of the bowie-dick test pack placement in the sterilizer chamber

In Built Temperature Sensor Placement In The Chamber And Justification For The Selection Of Location

Temperature Sensor Placement In The Empty Chamber And Justification For The Selection Of Location  

Schematic representation of temperature sensor placement in the empty chamber

Justification for the selection of locations for the temperature sensor placement in the empty chamber

 

Sensor No. Location In The Chamber Justification For Location Selection
1 In the active Chamber Drain (Near RTD -01) This is the location for the reference measurement point of the sterilizer, which controls the sterilization cycle. Hence important to compare the achieved temperature distribution results (strip chart/ print out of sterilizer) with the results from data logger.
2 Near RTD -02 As these are temperature recording probes at different points. It is necessary to verify/compare the temperature distribution obtained with strip chart / print out from the sterilizer
3 Near RTD – 03
4 Near RTD – 04
5 Near RTD – 05
6 Non-sterile door middle  

Any conduction of heat through the door, which may cause temperature drop at that particular point.

7 Non-sterile door left corner bottom
8 Non-sterile door right corner top
9 Chamber middle bottom To know the temperature distribution in these regions
10 Chamber middle top
11 Chamber middle
12 Sterile door left corner top  

Any conduction of heat through the door, which may cause temperature drop at that particular point.

13 Sterile door middle
14 Sterile door right corner bottom
15 Steam in let left side To verify the probability of excess temperature near the steam inlet.
16 Steam in let right side
(NOTE: The temperature sensors shall be placed in the pre determined locations with predetermined sensor numbers corresponding to the data logger channels).

Temperature Sensor Placement And Justification For Location Selection (Garment Load Maximum)

 Schematic representation of temperature sensor placement in the garment load

Justification for the selection of locations for the temperature sensor placement in the garment load

 

Load Details
12 pairs of aseptic area gowning Each one number of trunk, pair of booties and headgear in one cloth bag. Four such bags are placed side by side as one layer in the trolley and three such layers are loaded amounting to 12 pairs.
One numbers of glove packs Each containing 12 pairs of powder free latex gloves.
12 numbers of lint free mopping dusters Wrapped using parchment paper and arranged side by side

 

Sensor No. Location In The Chamber Justification For Location Selection
1 In the active Chamber Drain This is the location for the reference measurement point of the sterilizer, which controls the sterilization cycle. Hence important to compare the achieved temperature distribution results (strip chart/ print out of sterilizer) with the results from data logger.
2 Near RTD -02 As these are temperature recording probes at different points. It is necessary to verify/compare the temperature distribution obtained with strip chart / print out from the sterilizer
3 Near RTD – 03
4 Near RTD – 04
5 Near RTD – 05
6 Inside garments pack -01 To verify the temperature penetration in the innermost portion of these packs.
7 Inside garments pack -03
8 Inside garments pack -05
9 Inside garments pack -07
10 Inside garments pack -09
11 Inside garments pack -11
12 Inside mopping dusters pack top
13 Inside mopping dusters pack bottom
14 Inside the gloves pack
15 Chamber middle top To verify the temperature distribution above the packs in the bottom rack.
16 Chamber middle bottom

(NOTE: The temperature sensors shall be placed in the pre determined locations with predetermined sensor numbers corresponding to the data logger channels).

 

Temperature Sensor Placement In The Machine Parts Load 

Schematic representation of temperature sensor placement in the filling machine parts load

Justification for the selection of locations for the temperature sensor placement in the filling machine parts load

 

Sensor No. Location In The Chamber Justification For Location Selection
1 In the active Chamber Drain This is the location for the reference measurement point of the sterilizer, which controls the sterilization cycle. Hence important to compare the achieved temperature distribution results (strip chart/ print out of sterilizer) with the results from data logger.
2 Near RTD -02 As these are temperature recording probes at different points. It is necessary to verify/compare the temperature distribution obtained with strip chart / print out from the sterilizer
3 Near RTD – 03
4 Near RTD – 04
5 Near RTD – 05
6 Powder hopper top To verify the temperature penetration in the innermost portion of these parts.
7 Powder hopper bottom
8 Index wheel port
9 Rubber stoppers hopper
10 Dust collector set
11 Rubber stoppers chute
12 Sterilizing grade filter and tubing pack
13 Accessories (forceps etc)
14 Chamber middle bottom To verify the temperature distribution at these points during sterilization cycle.
15 Chamber middle top
16 Near steam inlet

(NOTE: The temperature sensors shall be placed in the pre determined locations with predetermined sensor numbers corresponding to the data logger channels).

Temperature Sensor Placement In The Filtration Accessories Load

Schematic representation of temperature sensor placement in the filtration accessories

Justification for the selection of locations for the temperature sensor placement in the filtration accessories load

 

Sensor No. Location In The Chamber Justification For Location Selection
1 In the active Chamber Drain This is the location for the reference measurement point of the sterilizer, which controls the sterilization cycle. Hence important to compare the achieved temperature distribution results (strip chart/ print out of sterilizer) with the results from data logger.
2 Near RTD -02 As these are temperature recording probes at different points. It is necessary to verify/compare the temperature distribution obtained with strip chart / print out from the sterilizer
3 Near RTD – 03
4 Near RTD – 04
5 Near RTD – 05
6 Membrane holder inside top To verify the temperature penetration in the innermost portions of the loaded items.
7 Membrane holder inside bottom
8 Pressure Vessel inside top
9 Pressure Vessel inside bottom
10 Pressure Vessel inside middle
11 Inside Silicon tubing
12 Inside Silicon tubing pack
13 Near steam in let To verify the temperature distribution at these points during sterilization cycle.
14 Near non-sterile door middle
15 Near sterile door middle
16 Chamber middle

(NOTE: The temperature sensors shall be placed in the pre determined locations with predetermined sensor numbers corresponding to the data logger channels).

 

Temperature sensor placement in the rubber stoppers load

Schematic representation of temperature sensor placement in the rubber stopper load

Justification for the selection of locations for the temperature sensor placement in the rubber stopper load

 

Sensor No. Location In The Chamber Justification For Location Selection
1 In the active Chamber Drain This is the location for the reference measurement point of the sterilizer, which controls the sterilization cycle. Hence important to compare the achieved temperature distribution results (strip chart/ print out of sterilizer) with the results from data logger.
2 Near RTD -02 As these are temperature recording probes at different points. It is necessary to verify/compare the temperature distribution obtained with strip chart / print out from the sterilizer
3 Near RTD – 03
4 Near RTD – 04
5 Near RTD – 05
6 Cassette 01 with stoppers To verify the temperature penetration in the innermost portions of the loaded items.
7 Cassette 02 with stoppers
8 Cassette 03 with stoppers
9 Cassette 04 with stoppers
10 Cassette 05 with stoppers
11 Cassette 06 with stoppers
12 Cassette 07 with stoppers
13 Cassette 08 with stoppers
14 Chamber middle top To verify the temperature distribution at these points during sterilization cycle.
15 Near non-sterile door middle
16 Near sterile door middle

(NOTE: The temperature sensors shall be placed in the pre determined locations with predetermined sensor numbers corresponding to the data logger channels).

NOTE: As it is not possible to insert the temperature sensors in the Rotating carriage of the bung processor during Sterilization and drying as the carriage rotates during the sterilization and drying process. Hence the basket drive of the equipment has been intentionally stopped and the sensors are introduced into the static carriage during this heat penetration study. This simulates worst case study of stationary load for sterilization and drying.

Temperature Sensor Placement In The Rubber Stoppers Holding Canisters

 Schematic representation of temperature sensor placement in the rubber stopper holding canisters load

Justification for the selection of locations for the temperature sensor placement in the rubber stopper holding canister load

 

Sensor No. Location In The Chamber Justification For Location Selection
1 In the active Chamber Drain This is the location for the reference measurement point of the sterilizer, which controls the sterilization cycle. Hence important to compare the achieved temperature distribution results (strip chart/ print out of sterilizer) with the results from data logger.
2 Near RTD -02 As these are temperature recording probes at different points. It is necessary to verify/compare the temperature distribution obtained with strip chart / print out from the sterilizer
3 Near RTD – 03
4 Near RTD – 04
5 Near RTD – 05
6 Inside canister -01 To verify the temperature penetration in the innermost portions of the loaded items.
7 Inside canister -02
8 Inside canister-03
9 Inside canister -04
10 Inside canister -05
11 Inside canister -06
12 Inside canister -07
13 Inside canister -08
14 Near non-sterile door middle To verify the temperature distribution at these points during sterilization cycle.
15 Near steam in let
16 Chamber middle

(NOTE: The temperature sensors shall be placed in the pre determined locations with predetermined sensor numbers corresponding to the data logger channels).

Temperature sensor placement in the media vessels with WFI

 Schematic representation of temperature sensor placement in the media vessels (with WFI) load

Justification for the selection of locations for the temperature sensor placement in the media vessels (with WFI) load

Sensor No. Location In The Chamber Justification For Location Selection
1 In the active Chamber Drain This is the location for the reference measurement point of the sterilizer, which controls the sterilization cycle. Hence important to compare the achieved temperature distribution results (strip chart/ print out of sterilizer) with the results from data logger.
2 Near RTD -02 As these are temperature recording probes at different points. It is necessary to verify/compare the temperature distribution obtained with strip chart / print out from the sterilizer
3 Near RTD – 03
4 Near RTD – 04
5 Near RTD – 05
6 Inside vessel –1 (top) To verify the temperature penetration in the innermost portions of the loaded items.
7 Inside vessel – 1 (bottom)
8 Inside vessel –2 (top)
9 Inside vessel – 2 (bottom)
10 Inside vessel –3 (top)
11 Inside vessel – 3 (bottom)
12 Inside vessel –4 (top)
13 Inside vessel – 4 (bottom)
14 Near non-sterile door middle To verify the temperature distribution at these points during sterilization cycle.
15 Near steam in let
16 Chamber middle

(NOTE: The temperature sensors shall be placed in the pre determined locations with predetermined sensor numbers corresponding to the data logger channels).

 

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