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
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))
Observations : Run – 1 /Run – 2/Run – 3
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 25oC.
Checks
Temperature in the expansion tube (Te)
The boiling point of water at local atmospheric pressure. (To)
Superheat = Te – To
Observations
- Run – 1 : 100 oC
- Run – 2 : 100 oC
- Run – 3 : 100 oC
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 |
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).
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 center of the chamber base. | |||
Steam sterile 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. |
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 |
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._____ |
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 Sterilization 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._____ |
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 Sterilization 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._____ |
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._____ |
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._____ |
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._____ |
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._____ |
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._____ |
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._____ |
Biological Indicator Incubation DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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 DetailsHeat 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: