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  • Validation of Incubators

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    ltrevino100
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    This document outlines procedures for validating incubators and hot air ovens used in a microbiology laboratory. It describes placing a standard thermometer in incubators at various locations and comparing readings to the displayed temperature over one hour to ensure the temperature is maintained within ±2% of the set point. It also details testing spore strips and endotoxin indicators after exposure in hot air ovens at 250°C for one hour to confirm reduction of microorganisms and endotoxins. The validation procedures are to be performed once per year and results recorded.

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    This document outlines procedures for validating incubators and hot air ovens used in a microbiology laboratory. It describes placing a standard thermometer in incubators at various locations and comparing readings to the displayed temperature over one hour to ensure the temperature is maintained within ±2% of the set point. It also details testing spore strips and endotoxin indicators after exposure in hot air ovens at 250°C for one hour to confirm reduction of microorganisms and endotoxins. The validation procedures are to be performed once per year and results recorded.

    Drepturi de autor:

    Attribution Non-Commercial (BY-NC)
    Descărcați ca DOC, PDF, TXT sau citiți online pe Scribd
    Indicator pentru conținut neadecvat
    1K vizualizări4 pagini

    Validation of Incubators

    Încărcat de

    ltrevino100
    This document outlines procedures for validating incubators and hot air ovens used in a microbiology laboratory. It describes placing a standard thermometer in incubators at various locations and comparing readings to the displayed temperature over one hour to ensure the temperature is maintained within ±2% of the set point. It also details testing spore strips and endotoxin indicators after exposure in hot air ovens at 250°C for one hour to confirm reduction of microorganisms and endotoxins. The validation procedures are to be performed once per year and results recorded.

    Drepturi de autor:

    Attribution Non-Commercial (BY-NC)
    Descărcați ca DOC, PDF, TXT sau citiți online pe Scribd
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    din 4

    VALIDATION OF INCUBATORS

    1.0 OBJECTIVE To lay down a procedure for validation of incubator in microbiology laboratory. 2.0 3.0 4.0 4.1 RESPONSIILTY Microbiologist / Executive. ACCOUNTABILITY Quality Assurance Control PROCEDURE DETAILS OF THE STANDARD THERMOMETER USED FOR VALIDATION OF LAB THERMOMETER. 4.1.1 4.1.2 4.1.3 ` 4.1.4 Type : Liquid - Glass lab Thermometer. Place the standard thermometer dipped in glycerin in incubator at various locations as mentioned in annexure-II. The incubator is set for desired temperature with the knob on control panel of incubator e.g 32.5 0C, 35 0C & 22.5 0C. Wait till the temperature reaches at set point & note down the temp. displayed on the small screen of incubator and compare this temp. with standard thermometer kept near the RTD probe.Likewise check the temperature after every 15 minutes up to one hour and note down the readings on the format. 4.1.5 4.1.6 Record any difference between the displayed temp. & temp. showed by standard thermometer and set the incubator accordingly Frequency of validation : once in a year. 4.1.7 4.2 OVEN): 4.2.1 Keep all the apparatus wrapped thrice with aluminum foil inside DHS as locations shown in the diagram. The observations are noted in the format of annexure-I PROCEDURE FOR VALIDATION OF D.H.S (HOT AIR

    4.2.2

    Keep the Spore loaded strips (having spore of B subilis)

    & Endotoxin indicator indicators having 10,000EU/vial in DHS(hot air oven) kept in 30ml vial wrapped thrice with aluminum foil at locations shown in the diagram keep one vial unbaked as PPC. 4.2.3 Set the hot air oven at 250C ,wait till the

    temperature reaches upto the set temperature. After reaching the set temperature, note the time & temperature, hold for one hour 4.2.4 After completion of depyrogenation cycle ,switch off the power supply and take out Indicators for testing. 4.3 Procedure for testing reduction of endotoxin as under . 4.3.1 4.3.2 Take out the baked endotoxin loaded vial from the DHS. Reconstitute 1ml of LRW in the baked vial and transfer

    100l of sample to the depyrogenated reaction tube kept in heating block at 370 C and add 100l of LAL in the same tube in duplicate. 4.3.3 4.3.4 4.4. 4.4.1 Prepare the dilutions for PPC for confirming Note the gel clot after incubation of one hour 10,000EU/vial . Procedure for testing of reduction of prepared spore Transfer (spore loaded) strip from backed vials and are

    loaded strip(B subtilis): inoculated in100ml sterile SCD media and incubate at 30 350C for 7 days to observe for any turbidity, if any, report to Manager QC.. 5.0 6.0 REASON FOR REVISION TRAINING: Head Quality Control Quality Control Chemists & Assistants One day Trainees-Period -Harmonization of format. Trainer -

    7.0

    DISTRIBUTION: : Head QUALITY ASSURANCE.

    Certified Copy No. 1 : Head of Department Quality Control Original Copy 8.0 9.0 ANNEXURES: REFERENCES:

    Annexure 1. Formats for Instrument validation. USP 25 page no.-1890 & 2251 ANNEXURE-1 INSTRUMENT VALIDATION . LOCATION MANUFACTURED BY IDENTIFICATION No. SET TEMPERATURE = TIME TEMP. RECORDED LOCATIONS INSIDE THE CHAMBER 1 2 3 4 5 6 INITI AL TEMP AFTE R 15 MIN AFTE R 30 MIN AFTE R 45 MIN AFTE R 60 C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C C Microbiology laboratory NAME OF INSTRUMENT MODEL No. INSTALLED ON Incubator

    DISPLAY MINIMUMMAXIMUM DEVIATION + ED TEMP.

    MIN LIMIT: 2% of Set Temperature CONCLUSION: The incubator is maintaining / does not maintaining set temperature within Specified limits. VALIDATED BY: CHECKED BY: DATE: DATE: NEXT VALIDATION MANAGER /QC DUE ON DATE Posted by Niazi at 11:13 PM Labels: VALIDATION OF INCUBATORS 0 COMMENTS:

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