Method statement for Autoclave temp mapping

Author:Dr. Deepak K Thakur Issue 3. Date: 22 Aug 2014

1) Use a Thermal chart recorder with a minimum of 24 calibrated T type thermocouples fitted.

Note 1:
All thermocouples must be referenced by checking them against a calibrated instrument (calibration must be
traceable to national standards). This referencing must be carried out immediately before the temperature
mapping is carried out and immediately after it is completed. These tests must be documented reviewed,
approved and attached to the temperature mapping protocol.

Note 2:
An autoclave cabinet leak test must be carried out and the leak rate of the cabinet (if any) recorded prior to
installation of recording temperature sensors. On completion of installation of temperature sensors and prior
to mapping commencing, a leak test must carried out once more to verify that the installation of the
temperature sensors has not created any addition leaks.

2) Commence referencing.

The referencing must be carried at three temperature points. These three points should be;

1) Circa 10% greater than the highest temperature to be mapped.

2) Circa 10% lower than the lowest temperature to be mapped.

3) Within Circa 10% of the mid point between the high and the low temperature.

Pre calibration of thermocouples must show all thermocouples to have a deviation of £0.2C from the
temperature standard and referencing records must be attached to the mapping protocol, along with the
calibration certificate for the test standard used.

3) Establish Response times.

On completion of the referencing, carryout a brief responseK time verification by;

Dr. Deepak Thakur

Since the calibration thermocouples will all be of the same type (i.e. cross sectional area and thermal
insulation) take any one of these along with the autoclave product probe and place them in your low
temperature source and allow to stabilize. Quickly remove them from the low temperature source and insert
them into the high temperature source. Examine the response trace from the two sensors, and note how much
longer it took the product probe to attain 70% of the step change induced.

Note 3: A standard open ended 0.2 m2 temperature sensor will have a response time of circa 3 seconds.
A Standard 8 mm mineral insulated product probe will have a response time of circa 25 seconds.

This means when reviewing the temperature traces, you must make allowances for the fact that the
temperature sensors will see; sense and record temperature changes circa twenty seconds before the autoclave
control system does.

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 Method statement for Autoclave temp mapping
Author:Dr. Deepak K Thakur Issue 3. Date: 22 Aug 2014

4) Install thermocouples.

Position the thermocouples uniformly within the cabinet, in three layers (roof, floor and half way in between).
Within these layers position thermocouples so that one is in each corner of cabinet and one is directly in the
middle). Inspect temperature sensor layout and ensure that this layout of sensors ensures that the entire
product process area will be monitored by the installed temperature sensors. Ensure that all the sensors are
securely supported and are not directly in contact with any internal structure. Record the positions of
thermocouples on a diagram and attach to the protocol.

5) Run a cycle using the highest temperature and pressures over the longest time period.

6) At each of the temperature step changes assess the printouts for the minimum and maximum
temperatures conformity with the master indicator.

7) Record the complete cycle.

8) Attach the printouts to the protocol

9) Attach the cycle printout to the protocol.

10) All thermocouples used are calibrated at a low point of —10°C, a high point of +55°C and followed by a
midpoint calibration check at around 10°C.

11) Pre calibration of thermocouples must show all thermocouples to have a deviation of £0.2°C from the
temperature standard and calibration reports are attached to protocol.

12) The locations of all thermocouples used are indicated on a drawing, which is attached to the protocol.

13) All thermocouples must record temperatures with a tolerance of ±1°C to each other, across each shelf
and between shelves.

14) All thermocouples must record temperatures with a tolerance of ±2°C to the setpoint.

15) Post calibration of thermocouples must show that all thermocouples are within 1°C of the temperature
standard at a midpoint calibration check of 0°C.

16) Assessment table completed satisfactorily.

17) Cycle printouts accompany the protocol.

Temperature Mapping Complete

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