1.0 PURPOSE :
This SOP provides an authorized procedure for cleaning, calibration and validation of BOD incubator.
2.0 SCOPE :
This SOP covers the cleaning, calibration and validation method for BOD incubator (QCI – 43).
3.0 RESPONSIBILITY :
Microbiologist.
4.0 ROCEDURE
4.1.0 CALIBRATION :
Calibration of temperature indicator view controller to be carried out once in a year by external agency or whenever any maintenance done on the apparatus.
4.1.1 :Maintain the record of calibration.
4.2.0 VALIDATION
4.2.1 :Perform the validation of B.O.D. Incubator once in a year.
4.2.2 :Follow the operating procedure for operation after altering set temperature perform the temperature mapping inside the chamber.
4.2.3 :Five calibrated thermometers are kept in different places inside the incubator.
4.2.4 :All the thermometers should maintain the temperature of
± 2 °C of set temperature for 8 hours.
4.2.5 :Maintain the records of validation.
4.3.0 CLEANING METHOD
4.3.1 Disconnect the BOD Incubator from main electrical supply.
4.3.2 Clean the outside and inside of incubator with dry non shredding cloth. Wipe with IPA 70% v/v.
4.3.3 Maintain the log book for cleaning.
4.3.4 Frequency : Once in a week.
As defined by regulatory standards, validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes.
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nice blog.MACK PHARMATECH PVT. LTD. PROVIDES Manufacturers of Pharma And Lab Equipments of BOD Incubator .
ReplyDeleteThis comment has been removed by the author.
ReplyDeleteSGM BOD incubators are designed to meet customized requirements of different customers, SGM as an experienced BOD incubator manufacturer in India, produces standard as well as customized BOD incubator models. These BOD Incubators come in various sizes and capacities such from 36 liters to 1000 liters. They are available in different designs for excellent quality performance.
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