Validation Observations Recording Format -I for steam steriliser and load Pattern

Validation Observations Recording Format -I for steam sterilizer and load Pattern

Recording Of Observations For Revalidation

Steam Quality Tests

Steam Non-Condensable Gas Test

When the temperature of the water in the container reaches 70-75°C close the needle valve. Note the volume of gas collected in the burette (Vb) and the volume of water collected in the measuring cylinder (Vc).

Calculate the fraction of non-condensable gases as a percentage as follows.

• Fraction of non-condensable gases = 100 x (V b/V c).
• The test should be considered satisfactory if the fraction of non-condensable gases does not exceed 3.5 %.

Checks	Observations
	Run – 1	Run – 2	Run – 3
The volume of gas collected in the burette (Vb)
The volume of water collected in the measuring cylinder (Vc)
Fraction of non-condensable gases as percentage. (100 x (V b/V c))
Done by Sign & Date
Checked by Sign & Date

Comments:

 Reviewed by:                                                                                             Date:

Super Heat Test

From the measured temperatures, note the temperature in the steam service pipe (for use in the dryness test) and in the expansion tube (Te) when the steam supply to the chamber first opens. Calculate the superheat in ^oC from the following equation:

Superheat = Te – To

Where:

To is the boiling point of water at local atmospheric pressure.

Acceptance criteria: The test should be considered satisfactory if the superheat measured in the expansion tube does not exceed 25^oC. 

Checks	Observations
	Run – 1	Run – 2	Run – 3
Temperature in the expansion tube (Te)
The boiling point of water at local atmospheric pressure. (To)	100 oC	100 oC	100 oC
Superheat = Te – To
Done by Sign & Date
Checked by Sign & Date

 Comments: 

Reviewed by:                                                                                             Date:

 Steam Dryness Test

Dryness value of the steam from the following equation:

D= (T1-T0) (4.18MW + 0.24) / LMC – 4.18 (TS-T1) / L

Where:

T0    =       Initial temperature of the water in the flask (^oC);

T1    =       Final temperature of the water and condensate in the flask (ºC);

TS   =       Average temperature of the steam delivered to the sterilizer (ºC);

MW  =       Initial mass of water in the flask (Kg);

MC   =       Mass of condensate collected (Kg);

L     =       latent heat of dry saturated steam at temperature TS (kJ Kg-1).

 

Checks	Observations
	Run – 1	Run – 2	Run – 3
Mass of Dryness test assembly (M1)
Mass of flask with cold water, stopper & tube assembly (M2) in kg
Temperature of the water in the flask before testing (T0)
Temperature in the steam service pipe (TS)
Temperature of the water in the flask after testing (T1)
Mass of flask stopper & tube assembly after test (M3) in kg
Initial mass of water in the flask is MW = M2-M1 in kg
The mass of condensate collected is given by Mc= M3 – M2. in kg
Dryness value of the steam as per the above formula

 Comments:

  Reviewed by:                                                                                             Date: 

Vacuum Leak Test

Checks	Readings from the Strip chart (in mbar)
	Run – 1			Run – 2			Run – 3
	Initial (P1)	After 3 min (P2)	After 10 min (P3)	Initial (P1)	After 3 min (P2)	After 10 min (P3)	Initial (P1)	After 3 min (P2)	After 10 min (P3)
Date of Test
Sterilization Chamber Pressure
Sterilization Chamber Temperature

Refer attachment (printouts):

Calculations:

Vacuum leak rate = (P2-P3/10) / mbarmin^-1

Run – 1

Run – 2

Run – 3

Result:        The vacuum leak rate in the sterilization chamber is within / not within the   acceptance limit (i.e., .1.3mbar/ min).

Comments: 

Reviewed by:                                                                                             Date:

Ref. 6.3          Bowie – Dick Test For Steam Penetration

 Details of Bowie-Dick test pack

Company Name:……………………………………………………………………………………………………………………….

Expiry……. …………….… Lot No… ……………….…… 

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Whether the test pack placed in the chamber with the bottom of the pack supported 100-200 mm above the centre of the chamber base.
Steam steriler operated as per the PLC set parameters
Strip chart print out shows the hold time as per the procedure mentioned
Colour of the indicator is changed uniformly.

 Comments: 

Reviewed by:                                                                                             Date:

F0 Value Calculation For The Biological Indicator Used

 Required F₀ Value Calculation For The Biological Indicator Used 

Biological Indicator Lot No.
Expiry date
D121 value
Spore population
Equation for required Fo value to get PNSU of 10-6 Or 12 log reduction in the biological indicator	FO =D121 (logA-logB)
Calculation	FO =   _____(…………..…… – …………………)
FO value required to get PNSU of 10-6	…………….Minutes
FO value required to get PNSU of 10-12	…………….Minutes

Comments: 

Reviewed by:                                                                                             Date:

Heat Distribution Empty Chamber

 

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 2 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments: 

Reviewed by:                                                                                             Date:

Heat Distribution Studies

 Heat Distribution Study of Garment Load (Minimum) 

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments: 

Reviewed by:                                                                                             Date:

Heat Distribution Study of Garment Load (Minimum) 

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments:

Reviewed by:                                                                                             Date:

Heat Distribution Study-Filling Machine Parts  

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments: 

Reviewed by:                                                                                 Date:

 Heat Distribution Study – Filtration Accessories 

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments:

Reviewed by:                                                                                             Date:

Ref. 6.6.5   Heat Distribution Study – Rubber Stoppers (Minimum) 

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments: 

Reviewed by:                                                                                             Date:

 

Heat Distribution Study – Rubber Stoppers (Maximum) 

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments: 

Reviewed by:                                                                                             Date:

 Heat Distribution Study – Rubber Stopper Holding Canisters 

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments: 

Reviewed by:                                                                                             Date:

Heat Distribution Study – Media Vessels With WFI Water 

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments: 

Reviewed by:                                                                                             Date:

• Heat Penetration Studies

Heat Penetration of Garment Load (Minimum)

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments:

Reviewed by:                                                                                             Date:

Biological Indicator Incubation Details                                  Heat Penetration of Garment Load (Minimum)
Run No		1			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details                                  Heat Penetration of Garment Load (Minimum)
Run No		2			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details                                  Heat Penetration of Garment Load (Minimum)
Run No		3			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Heat Penetration of Garment Load (Maximum)

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments: 

Reviewed by:                                                                                             Date:

Biological Indicator Incubation Details                                  Heat Penetration of Garment Load (Maximum)
Run No		1			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details                                  Heat Penetration of Garment Load (Maximum)
Run No		2			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details                                  Heat Penetration of Garment Load (Maximum)
Run No		3			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Heat Penetration Study-Filling Machine Parts

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments:

Reviewed by:                                                                                             Date:

Biological Indicator Incubation Details                                  Heat Penetration Study-Filling Machine Parts
Run No		1			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle. 

Biological Indicator Incubation Details                                  Heat Penetration Study-Filling Machine Parts
Run No		2			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth/growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details                                  Heat Penetration Study-Filling Machine Parts
Run No		3			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Heat Penetration Study – Filtration Accessories

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments:

Reviewed by:                                                                                             Date:

Biological Indicator Incubation Details Heat Penetration Study – Filtration Accessories
Run No		1			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details                                  Heat Penetration Study – Filtration Accessories
Run No		2			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details                                  Heat Penetration Study – Filtration Accessories
Run No		3			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

 Heat Penetration Study – Rubber Stoppers (Minimum)

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments:

Reviewed by:                                                                                             Date: 

Biological Indicator Incubation Details Heat Penetration Study – Rubber Stoppers (Minimum)
Run No		1			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle. 

Biological Indicator Incubation Details Heat Penetration Study – Rubber Stoppers (Minimum)
Run No		2			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details                                  Heat Penetration Study – Rubber Stoppers (Minimum)
Run No		3			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.
Heat Penetration Study – Rubber Stoppers (Maximu

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____
Done by Sign & Date
Checked by Sign & Date

Comments: 

Reviewed by:                                                                                             Date:

Biological Indicator Incubation Details Heat Penetration Study – Rubber Stoppers (Maximum)
Run No		1			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details                                  Heat Penetration Study – Rubber Stoppers (Maximum)
Run No		2			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details                                  Heat Penetration Study – Rubber Stoppers (Maximum)
Run No		3			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Heat Penetration Study – Rubber Stopper Holding Canisters

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments:

Reviewed by:                                                                                             Date:

 

Biological Indicator Incubation Details Heat Penetration Study – Rubber Stopper Holding Canisters
Run No		1			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth/growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details  Heat Penetration Study – Rubber Stopper Holding Canisters
Run No		2			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details                                  Heat Penetration Study – Rubber Stopper Holding Canisters
Run No		3			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Heat Penetration Study – Media vessels with WFI water

Checks	Observations Yes/No
	Run – 1	Run – 2	Run – 3
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation hold time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
F0 value for the biological indicator of each location is complies with the requirement.
Write the minimum & maximum F0 values.	Min._____ Max._____	Min._____ Max._____	Min._____ Max._____

Comments:

Revised by:                                                                                             Date:

Biological Indicator Incubation Details Heat Penetration Study – Media vessels with WFI water
Run No		1			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details  Heat Penetration Study – Media vessels with WFI water
Run No		2			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle.

Biological Indicator Incubation Details                                  Heat Penetration Study – Media vessels with WFI water
Run No		3			Date of Testing
Lot No. of Media					Date of Report
Details of observation of incubation
Biological Indicator No.	Days
	1		2	3		4	5		6	7
1
2
3
4
5
6
7
8
9
10
11
12
+ Ve Control
– Ve Control
Observed by

Note: ‘+ Ve’ Indicates growth; ‘-ve’ Indicates No growth

Remarks: No growth / growth observed in the inoculated tubes (s) indicates that all spores are killed / not killed on exposure of the subjected sterilization cycle

Discrepancy And Corrective Action Report

Reference               : Discrepancy             : Corrective Action: Satisfactorily completed? [Yes / No]: Checked by / date:                                                   Reviewed and approved by / date:

Remarks: