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