SOP for Physical Monitoring of Microbiology Section : Pharmaceutical Guidelines

SOP for Physical Monitoring of Microbiology Section

Standard operating procedure for monitor the temperature, differential pressure & UV light burning hours of micro section

1.0 OBJECTIVE

To monitor the temperature, differential pressure & UV light burning hrs of the micro section.

2.0 SCOPE

It is applicable to monitor and record the differential pressure, temperature & UV light burning in the various area of the micro section.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant/ Executive
3.3 Checking: Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Before starting work observe the differential pressure of Magnahelic gauge of following room.

Area
Limit (Pascal)
Airlock of Inoculation room
NLT 15
Inoculation room
NLT 15
Passage
NLT  5
Media preparation
NLT 5
Airlock I
NLT 5
Airlock II
NLT 5
Airlock III
NLT 5
Cooling zone
NLT 15
Sterility test room
NLT 5
5.2 Record the reading.
5.3 “ON” the UV light of all area, after shift end & “off” the UV light before starting the work.
5.4 Observe the UV light Burning hours from UV light Burning hours meter of the following area
UV light Burning hours meter - box I
1. Airlock II
2. Airlock III
3. Cooling zone
On UV light Burning hours meter Box II
1. Sterility Room
2. Inoculation Room (Microbiology Room)
3. Airlock I of Inoculation Room
5.5 Record the observation.
5.6 Replace the UV light after completion of 6000 hours of burning and record.
5.7 Observe the temperature with calibrated thermometer of following area, three times a day.
1. Walk-In –Incubator (30-35°C)
2. Walk-In – Incubator ( 30-35°C)
Record the result in Annexure-I.

Acceptance criteria : -

Walk-In-Incubator (30-35°C) --> Temperature should be 30-35°C
Walk-In-Incubator (30-35°C) --> Temperature should be 30-35°C
Also verify the temperature in circular chart recorder. Replace the chart with new one
After 24 hours.

6.0 ABBREVIATION

UV light = Ultra Violet light
NLT = Not less than

ANNEXURE –I
MICROBIOLOGY LAB, Q.C.
TEMPERATURE RECORD OF WALK-IN INCUBATOR
MONTH_________________


DATE

WALK IN INCUMBATOR
(20 to 25°C)
WALK IN INCUBATOR
(30 to 35°C)
SIGN
&
RRMARK
Time à
1
3
3
1
3
3
9:00
13:00
17:00
9:00
13:00
17:00















































































       
           Acceptance criteria:
           Walk in-incubator    (20-25°C)  à  Temperature should be within 20-25°C
 Walk in-incubator (30-35°C)  à   Temperature should be within 30-35°C

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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