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

Recording Of Observations For Revalidation

Identification Of The Executors

 

S. No. Name Designation & Department Sign & Date Training Details
       

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 25oC. 

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      
Done by

Sign & Date

     
Checked by

Sign & Date

     

 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
Done by

Sign & Date

Checked by

Sign & Date

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.      
Done by

Sign & Date

     
Checked by

Sign & Date

     

 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
Done by

Sign & Date

Checked by

Sign & Date

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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._____

Done by

Sign & Date

     
Checked by

Sign & Date

     

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:

Reference               :

Discrepancy             :

 

Corrective Action      :

 

Satisfactorily completed? [Yes / No]:

Checked by / date:                                                   Reviewed and approved by / date:

Reference               :

Discrepancy             :

 

 

Corrective Action      :

 

Satisfactorily completed? [Yes / No]:

Checked by / date:                                                   Reviewed and approved by / date:

Remarks:

 

 

 

 

 

 

 

 

 

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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