BATCH PASTEURISER VALIDATION
Section 8
Comments
What is the desired outcome? To validate the pasteurization operation. Reduces the microbial load
Scope and Purpose Validation
Hazard identification - what is the hazard being considered Microbial laod should be under limit
Model reference
Regulatory limits
Person responsible for the validation (including external or
Competencies
Maintenance Manager
in house technical expert)
Is it necessary to train personnel on the process line prior
YES
to starting validation?
effectiveness will
Criteria against
be determined
TPC- Max- 1000, Yeast & Mold- 100, Staphylococus aureus-Ab/25 ml, Salmonella-A
which
Regulatory or operator defined limit
Listeria monocytogens-Ab/25 ml, E-coli 0157
Temperature distribution test across the volume of water.
• Identify possible cold spots within the batch system.
• Establish frequency of readings of various locations
within the heat treatment system.
• Is it within 0.5oC across the batch vessel.
If it is not possible to test and check the coldest spot within
the batch system, due to difficulties when placing different
temperature sensors, an alternative solution shall be
coldest spot within batch system is not possible to check.
considered, including validation using equipment supplier
data or computer simulation. e.g. moisture measurement to
check homogeneity
Run the trial in water and check if the pasteuriser set-up is
able to achieve the required time and temperature (including
the minimum head space temperature). The trial can be run Trial run has been conducted on water & checked for desired temperature ac
with product, but the product disposition needs to be
defined in advance. (Refer to Sheet "Record")
Trial Design
Test the alarms (if applicable) for temperature below the
Auto cut the
setpoint and head space temperature below the set point.
Test what happens if the agitator stops working or if the Before trial working of agitator shaft has been checked. Or recirculation pump us
cover is opened during pasteurisation. mixing & heat distribution
Number of trials conducted (Minimum 3 separate
Planned 3 separate trial Batches
batches/runs in worst case scenario)
Best case scenario evaluated
Worst case scenario evaluated
Any assumptions made
disposition
Product
How the product resulting from the trials is to be disposed
Results
- Overview of the data collected
- Analysis of the data
Conclusion
- Have the desired outcomes been achieved ?
- Does the evidence support the conclusions made? If not,
the trial design needs to be adapted.
URISER VALIDATION
Section 8
Comments
To validate the pasteurization operation. Reduces the microbial load
Microbial laod should be under limit
Maintenance Manager
YES
- Max- 1000, Yeast & Mold- 100, Staphylococus aureus-Ab/25 ml, Salmonella-Ab/25ml,
Listeria monocytogens-Ab/25 ml, E-coli 0157- Ab/25 ml .
coldest spot within batch system is not possible to check.
Trial run has been conducted on water & checked for desired temperature achieved.
Auto cut the
efore trial working of agitator shaft has been checked. Or recirculation pump used to proper
mixing & heat distribution
Planned 3 separate trial Batches
Section 9
Trial 1 Trial 2
Trial date
Batch size used
Volumetric qty
700±50 kg
Temperature of the jacketed water/steam(In case of steam pressure to be verified)
Maximum Temperature 63 deg cel
Minimum Temperature 65 deg cel
Temperature above which the discharge opens (In case of automatic) 65 deg cel
Is Average difference in temperature from the reference and test probes
±0.5
Trial 3
Batch Pasteuriser Simulated Time - Temperature Measurement
Time and Temperature of simulated batch run
Recording Probe Indicating Probe Air Space Probe
Time
Reading (°C) Reading (°C) Reading (°C)
DRAWING OF THE BATCH PASTEURISER SHOWING:
Agitator location
Product temperature probe
Location of the coldest spot
Temperature verification point
The following thermal process equation may be used to calculate equivalent time/temperatures (critical limits) when actual
temperatures applied are different than those stated in the CCP Models:
F FR X 10
((𝑇𝑅−𝑇))/𝑍
T = actual applied temperature
F = the time required at actual applied temperature T
FR = the time required at given TR (i.e. the time/temp. stated in Model CCP)
the z-value is the increase/decrease in temperature required to decrease/increase time by a factor of
z =
(see z-value in Model CCP)
Calculator
TR FR T
z
Temperature Time required at
z-value stated in Actual applied
stated in model given TR (stated in
CCP model temperature
CCP model CCP)
65 30 7.1 85
The above calculator can be applied for following CCPs :
Model 6 Model 47
Model 9 Model 48
Model 10 Model 51
Model 23 Model 52
Model 25 Model 58
Model 32 Model 60
Model 37 Model 61
Model 38 Model 65
Model 40 Model 69
Model 46 Model 71
al limits) when actual
ncrease time by a factor of 10
Time required at
actual applied
temperature
0.05 0.182928 10 mts
