Validation Observations Recording for steam sterilizer and load Pattern in pharma
Recording Of Observations For Revalidation
Steam Quality Tests
1. 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 a percentage. (100 x (V b/V c))
Observations: Run – 1 /Run – 2/Run – 3
2.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.
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
3. Steam Dryness Test
The 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).
Checklist for Observation of 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
The dryness value of the steam as per the above formula
Vacuum Leak Test
Date of Test –
Checkpoint – Sterilization Chamber Pressure and Sterilization Chamber Temperature
Readings from the Strip chart (in mbar) for Run 1/Run 2/Run 3
At Initial (P1) / After 3 min (P2) / After 10 min (P3)
Refer attachment (printouts):
Calculations: Vacuum leak rate = (P2-P3/10) / mbar/min
Result: 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… ………………
Observations Yes/No for Run 1/Run 2/Run 3
Checks
Whether the test pack was 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
The strip chart printout shows the hold time as per the procedure mentioned
The 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 | |
| The equation for the required Fo value to get PNSU of 10-6 Or 12 log reduction in the biological indicator | FO =D121 (log A-log B) |
| 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
Observations Yes/No for Run 1/Run 2/Run 3 – Min.& Max.
Checks
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation holds time within the sterilization temperature band of 121 to 124ºC. Observed Lag period (Should be NMT 2 minutes)
The F0 value for the biological indicator of each location complies with the requirement.
Write the minimum & maximum F0 values.
Heat Distribution Studies for (Minimum Load) Heat Distribution Study of Garment Load /Media Vessels With WFI Water /Filling Machine Parts /Filtration Accessories/ Rubber Stoppers /Rubber Stopper Holding Canisters
Observations Yes/No for Run 1/Run 2/Run 3 – Min.& Max.
Checks
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilization holds time within the sterilization temperature band of 121 to 124ºC.
Observed Lag period (Should be NMT 5 minutes)
The F0 value for the biological indicator of each location complies with the requirement.
Write the minimum & maximum F0 values.
Heat Penetration Studies for Minimum Load of Garment Load
Observations Yes/No for Run 1/Run 2/Run 3 – Min.& Max.
Checks
Date of test
The measured temperature in the sterilizer chamber is found uniform.
The temperature in the Sterilisation holds time within the sterilization temperature band of 121 to 124ºC. Observed Log period (Should be NMT 5 minutes).
The F0 value for the biological indicator of each location complies with the requirement.
Write the minimum & maximum F0 values.
Biological Indicator Incubation Details for Heat Penetration (Minimum and Maximum Load) of Garment Load /Media Vessels With WFI Water/Filling Machine Parts /Filtration Accessories/ Rubber Stoppers /Rubber Stopper Holding Canisters
Run No. 1,2,3 /Lot No. of Media/Date of Testing /Date of Report
Details of observation of incubation / Biological Indicator No. / Incubation Days
+ Ve Control & – Ve Control and 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 to 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: