Depyrogenation of Glassware and Apparatus
1.0 Objective
To lay down a procedure for depyrogenation of glassware and apparatus by hot air oven.
2.0 Scope
This Standard Operating Procedure is applicable for Depyrogenation of glassware and apparatus used in microbiology Lab at formulation plant of abc company.
3.0 Responsibility
3.1 Officer / Executive Quality Control is responsible for Depyrogenation of glassware and apparatus.
3.2 Head Quality Control is responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
Depyrogenation : Process in which remove the endotoxin
0C : Degree Centigrade
5.0 Procedure
5.1 Wrap the test tubes and glassware in aluminum foil and place in the hot air oven.
5.2 Close the door of the hot air oven and connect the instrument with main power supply.
5.3 Switch on the instrument main supply & red button will glow on the front panel.
5.4 Note down the time when the temperature of the oven attain 2000C. Maintain the temperature at 2000C for 2 hours.
5.5 After completion of cycle put off the hot air oven, allow the temperature to come down at about 400C.
5.6 Remove the Depyrogenation glass wares and apparatus wearing the sterile gloves.
5.7 Enter the details such as load no.( MD-XX-MM-YY), load details, and temperature attain time, cycle completion time, done by and checked by of Depyrogenation cycle in the Annexure –I.
5.8 MD is indicate depyrogenation cycle, XX denote serial no and MM for Month and YY for Year.
5.9 Mention the date of depyrogenation on the pack of glassware.
6.0 Forms and Records
6.1 Format for Depyrogenation Record – Annexure-1
7.0 Distribution
7.1 Master copy – Documentation Cell (Quality Assurance)
7.2 Control copy – Quality Control
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
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sop for preservatives efficacy test
sop for collection and preservation of in house isolated microorganisms
sop for Operation Calibration and Maintenance of Micropipette
sop for microbiological testing of water
sop for depyrogenation of apparatus
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sop for monitoring by active air sampler
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