Procedure for temperature & Humidity monitoring

1.0	PURPOSE To lay down systematic procedure for monitoring & recording of Temperature and Relative Humidity (RH) in controlled and uncontrolled areas.
2.0	SCOPE This method is applicable to all the controlled and uncontrolled areas within the factory premises.
3.0	RESPONSIBILITY Production Chemist/ IPQA Chemist.
4.0	ACCOUNTABILITY Head Production/Head QA
5.0	PROCEDURE
5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.5.1 5.2.6 5.2.7 5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.3.5 5.3.6 5.4 5.4.1 5.4.2 5.4.3 5.5 5.5.1 5.5.2 5.5.3 5.3.4 5.3.5 5.3.6 5.7 5.7.1 5.7.1 5.7.2 5.8 5.8.1 5.9 5.9.1	CHECKS BEFORE OPERATION OF DRY & WET BULB THERMOMETER: Check and ensure that the wick is fixed on the wet bulb hygrometer. Fill the column with water (Purified water) at the start of the shift. Check and make certain that the wick is wet. Check the mercury columns of the thermometer for any breakage. OPERATION: Note the reading of wet and dry bulb hygrometer in the cubicle. Subtract the reading of the wet bulb from that of dry bulb column, thus arriving at the depression value. Refer Temperature and Humidity Chart to locate the readings of dry bulb and the depression value given by the hygrometer. Read the % RH at the intersection of the two columns. In case values of  dry bulb and depression of wet bulb fall between those indicated on chart, interpose the values as given below. The dry bulb reading indicates the temperature of the area. The following examples illustrate the method of using the table.                         Dry Bulb temperature …………. 23.5ºC                         Wet Bulb temperature ………….16ºC                         The depression of the wet Bulb: 23.5ºC – 16.0ºC =7.5ºC.                         In order to find the relative humidity, it is necessary to interpolate between the                        “Dry Bulb”     columns 23 and 24 and the “Depression of Wet Bulb” columns 7.5.                         The readings are as follows:                          RH % reading 41% Record the Temperature & Relative Humidity in the format Attachment-1 ‘Temperature and Relative Humidity Record’ The area and operating range for temperature and relative humidity is mentioned in Attachment II. If any discrepancy is observed, Inform to Q. A. & Maintenance Dept. and further action should be taken in consultation with QAHead. PRECAUTIONS: Before swinging the hygrometer in the air, ensure that the hygrometer will not hit with the wall or with the nearby equipment. Ensure that sufficient water (Purified water) is available in the cistern. Ensure that the wick is wet and the bottom end is always immersed in water. Ensure that the top end of the wick covers the bulb completely. Check and ensure that no scales or deposit are observed on the wick. Replace the wick as and when required. Change the water in the cistern daily or as and when required. PRECAUTIONS TO BE TAKEN DURING HANDLING OF HYGROMETER Ensure that product in the respective area is in closed condition. Before swinging the hygrometer in the air, ensure that the hygrometer will not hit with the wall or with the nearby equipment. While handling it, if hygrometer is damaged inform to QA and get replaced with new calibrated hygrometer. OPERATION OF DIGITAL THERMO HYGROMETER Uncover the battery cover according to the arrow direction on it. Pull out the insulation paper & push back the cover. then the meter works.             Key function             [MODE] Switching between CLOCK & ALARM display.             [ADJ] Adjust value of the setting.             [MEMORY] Display or clear memorized MAX & MIN value of TEMP & humidity.             [RESET] Clear all set memorized value.             [C/F] Change temp unit between ◦C & ◦F. Press & hold [MODE] key 2 sec at starting up then minute reading will twinkle. Press[ADJ] to set Minute value, continuously press [MODE] Key with using [ADJ] to set value of hour. At current status (the dot between HOUR & MINUTE twinkles] press [MODE] once to change CLOCK display to alarm function Press [MEMORY] one time to display memorized MAX value of temp & humidity press another time to display MIN value of temp & RH. Press [MEMORY] for 2 seconds to clear memorized MAX & MIN value of temperature & Humidity. Record the Temperature & Relative Humidity at about the format Attachment-I ‘Temperature and        Relative Humidity Record’ The area and operating range for temperature and relative humidity is mentioned in Attachment II. If any discrepancy is observed, Inform to Q. A. & Maintenance Dept. and further action should be taken in consultation with QA manager. PRECAUTION Press key [RESET] for the first time use & after replacing battery. If any abnormal display appears press [RESET] key. While handling it, if hygrometer is damaged inform to QA and get replaced with new calibrated hygrometer. CALIBRATION: Hygrometer should be calibrated yearly by approved external agency. FREQUENCY FOR MONITORING:  Check and record the Temperature and Relative Humidity at about 11:30±30 minutes and 16:30±30    Minutes.
6.0	REFERENCES      Instrument Manual
7.0	ANNEXURES

Annexure No.	Title of Annexure	Format No.
Annexure I	TEMPRATURE & HUMIDITYB RECORDS	QA/028/F01-02
Annexure II	TEMPRATURE & RH CHART	QA/028/F02-02

8.0	ABBREVIATIONS

Abbreviations					Full Forms
SOP					Standard Operating Procedure
QA					Quality Assurance
9.0	DISTRIBUTION
Master Copy							Quality Assurance Department
Controlled office Copy No. 1							Quality Assurance Deptt.
Controlled office Copy No. 2							Quality Control Deptt.
Controlled office Copy No. 3							Production (Tablet) Deptt.
Controlled office Copy No. 4							Production (Liquid) Deptt
Controlled office Copy No. 5							Production (Lotion) Deptt
Controlled office Copy No. 6							Production (Soap) Deptt
Controlled office Copy No. 7							Ware house Dept. (Main Block)
Controlled office Copy No. 8							Ware house Dept.(External Block)
10.0		REVISION HISTORY
S.No.			Revision No.	Effective Date		Reason for Revision		Details of Change	Authorized By (sign & Date)

Annexure I

TEMPERATURE & RH RECORD

INSTRUMENT ID. NO.					MONTH/YEAR
DEPT.					LOCATION
Sr. No.	Date	Time	Temperature in °C		RH %	Recorded by		Verified By         IPQA	Remarks
			Dry Bulb	Wet Bulb

Annexure II

TEMPRATURE & RH CHART

Soap Section: 1. Manufacturing Area Temperature 230C+ 20C RH 55%+ 5%

Packing areas of all the section: Temperature 230C+ 20C RH 55%+ 5%

Tablet Section: 1. Granulation Area 2. Lubrication Area 3. Compression Areas 4. Coating Area Temperature 230C + 20C RH 55% + 5%	Liquid & Oral Section: 1. Manufacturing Area 2. Filling Area 3. Bottle Washing Area Temperature 230C+ 20C RH 60% + 5%
Lotion & Ointment Section: 1. Manufacturing Area 2. Filling Area Temperature 230C+ 20C RH 60% + 5%	Quality Control Lab: Temperature 230C+ 20C RH 55% + 5%
Store: Temperature 230C+ 20C RH 55%+ 5%