This document details the procedure for the Operation and Calibration of the Muffle Furnace or Muffle furnace calibration.
It is the policy of Xyz Pharmaceuticals Limited that a
written procedure shall be followed the Operation and Calibration of
Muffle Furnace and its use monitored in order to ensure smooth
operation to obtain consistent and reproducible results and minimize
downtime and meet regulatory
requirements
This
procedure is to be applied at the time of Operation and Calibration
of the Muffle Furnace.
RESPONSIBILITY AND accountability
Persons
along with their responsibilities and accountability are given below:
Executive - Corporate Quality Assurance:- To prepare the SOP
Trainee Analyst/ Jr. Analyst/ Analyst/ Sr. Analyst:- To
follow the SOP accordingly
Manager - Technical:- To ensure
implementation of SOP.
Muffle furnace Calibration Procedure
5.1 CLEANING
5.1.1 Clean the outside surface of the instrument with a Clean Cloth.
5.2 PRECAUTION OF MUffle FURNACE
5.2.1 Keep the instrument clean and dust-free.
5.2.2 Temperature in the muffle furnace is too high so always use long arm tongue.
5.2.3 Do not keep the door of the instrument open for a long period when the
temperature is in “ON” condition
5.3 OPERATION
5.3. Switch “ON” the main power supply of the instrument.
5.3.2 The required temperature can be set by a thermostatically controlled knob, by
rotating it in a clockwise or anti-clockwise direction.
5.3.3 Ensure that the temperature indicator/controller is in working condition i.e.
the set temperature should be maintained/retained properly.
5.3.4 Put
the objects /crucibles that required ignition by using a long arm tongue and close
the door.
5.3.5 Ensure that the door of the muffle furnace is properly closed and does not loosen
during operation.
5.3.6 Maintain the logbook of Muffle Furnace on XYZ/CQA/SOP-067/FR-01, Logbook for Muffle Furnace (Appendix I).
6.0 CALIBRATION
6.0.1 Calibration Frequency: Half Yearly.
6.0.2 Calibrated Platinum resistance thermometer(Range 0-1000°C) with sensor and
digital temperature indicator is used for the calibration of the instrument.
6.0.3 Insert the sensor of the reference/calibrator sensor (PRT) in the muffle
furnace as near as possible to the sensing tip or sensor of the
temperature controller/indicator of the laboratory.
6.0.4 SET THE TEMPERATURE AT 600˚C & 800˚C
OF THE MUFFLE FURNACE.
6
0.5 When the temperature is stable note down the temperature
reading as displayed by the muffle furnace and Reference PRT Thermometer
simultaneously
6.0.6 Record the temperature readings at 2 hours and 4 hours.
6.0.6 Correlate the readings observed with the reference standards and apply
corrections, if necessary.
6.0.7 For the calibration of the Muffle furnace having a range of 800˚C follow the steps6.0.2 to 6.0.6.
6.0.8 Record
all the calibration data on XYZ/CQA/SOP-067/FR-02, Calibration Data Sheet
Appendix II (Page 1 of 1)
6.0.9 After the calibration of the instrument, affix the calibration tag on the
instrument and fill all the required details as per SOP No. XYZ/CQA/SOP-006,
Labelling Policy.
6.0.10 Report any discrepancy observed during operation and calibration of instrument to Section. In charge or his representative for corrective and preventative action (as per XYZ/CQA/SOP-030)
6.0.11
Section In charge or his representative will take the necessary action
and report the same to Manager-Quality Assurance.
6.0.12
Affix “ Out of Order” label on the Muffle Furnace.
7.0 GENERATION OF INSTRUMENT CALIBRATION NUMBER
Generate
the instrument calibration number on the calibration datasheet as INSCALXXYYZZZ
where INS denotes instrument, CAL denotes calibration, XX denotes the year, YY
denotes month and ZZZ denotes sequence number.
8.0 ABBREVIATION
XYZ Xyz
Pharmaceuticals Limited
SOP Standard Operating Procedure
QC Quality Control
CQA Corporate Quality Assurance
(B) 1.0 OBJECTIVE
1.1 To
lay down the procedure for MUFFLE
FURNACE operation.
2.0 SCOPE
2.1 This procedure applies to Quality Control Department.
3.0 RESPONSIBILITIES
3.1 QC
chemists to prepare and follow the SO.
3.2 Head – QA & QC for implementation of SOP.
4.0 PROCEDURE
4.1 OPERATION:
4.1.1 Load
the testing material in the furnace and shut down the door.
4.1.2 Before
switching on the main, the knob of the energy regulator should be at the “OFF”
position.
4.1.3 Switch
ON the instrument.
4.1.4 Set
the desired temperature with the help of the Digital temperature controller.
4.1.5 Note
the time, when the temperature reaches the desired temperature.
4.1.6 Run
the instrument for the required period of time.
4.1.7 Unload
the testing material and shut down the door.
4.1.8 Switch
off the furnace, if not in use.
4.2 PRECAUTION:
4.2.1 Ensure
that the instrument is cleaned before and after use.
4.2.2 Metal
oxides, hardening, and reducing agent, salt-like substances which should not get
in touch with the muffle.
4.2.3 The
material to be treated should not occupy more than 50-70% of the heating space.
4.2.4 All
the repair work on the furnace must be done only with the power main being
switch off.
4.2.5 Do
not disturb the thermostat knob once the temperature is set.
4.2.6 Avoid
touching the instruments with a wet hand.
5.0 ABBREVIATIONS
SOP: Standard
Operating Procedure
QA: Quality Assurance
QC: Quality Control
6.0 REFERENCE: NIL
