Monitoring Of Environmental Conditions of control Sample Room

1.0.            OBJECTIVE:

           

            To lay down the procedure for daily monitoring of environmental conditions i.e. Temperature and   Relative Humidity in Control Sample Room

2.0.            RESPONSIBILITY:

2.1        The Chemist Quality Assurance shall be:

2.1.1     Responsible for daily monitoring the environmental conditions

2.1.2.    Responsible for recording the environmental conditions in the environmental monitoring Record

2.2        The Executive Quality Assurance shall be:

2.2.1     Responsible for ensuring the daily monitoring the environmental conditions.

2.2.2     Responsible for ensuring the environmental conditions are in the specified limit.

3.0.            ACCOUNTABILITY:

Head of Departmental – Quality Control

4.0.            PROCEDURE:

4.1        Humidity & Temperature Recording

Ø      Use calibrated Hygrometer for recording of Relative Humidity and Temperature by the following procedure.

Ø      Check the water level and fill the water compartment with water by using wash bottle.

Ø      Ensure that the wick is clean and soaked in water to ensure constant flow of water to the wet bulb.

Ø      Remove the hygrometer from the wall and swing it at about 45° angle about 100 rotations and check the readings till constant readings are attained. Take care while swinging the Hygrometer to avoid spillage of water from the water compartment.

Ø      Note down the temperature readings of dry and wet bulbs in degree Celsius.

Ø      Subtract wet bulb temperature reading from the dry bulb temperature reading to get the depression in temperature of wet bulb in degree Celsius.

Ø      Record the percent relative humidity from the RH table corresponding to dry bulb temperature along the left side of the table and depression of wet bulb temperature along the top of the table.

Ø      Record dry bulb temperature; wet bulb temperature and relative humidity twice in a day on the ‘Environmental Monitoring Record’ (Annexure – 1) of predetermined areas.

Ø       If there are any abnormal observations, in the readings of temperature, head of the Department shall be intimated for necessary actions in coordination with Head – Engineering.

Ø       Acceptence Creteria :- Temperature should be below 25⁰ C.

Annexure – 1                :  Format for Environmental Condition Monitoring Record 

ANNEXURE – 1

             FORMAT FOR ENVIRONMENTAL CONDITION MONITORING RECORD            

REF. SOP NO.:	Revision No.     :  00	Page No.:  1 of 1
	Effective Date   :

Area/Room:			Month:				Acceptance Criteria :-Temp. Below 250 C
Date	Time	Temperature (°C)			% RH	Recorded By		Verified By	Remark
		Dry Bulb		Wet Bulb

FORMAT FOR CALIBRATION RECORD OF HPLC

Annexure – 1    :  Format For Calibration Record Of Pump (Flow Rate)

Annexure – 2    :  Format For Calibration Record Of Gradient Proportionate Valve

Annexure – 3    :  Format For Calibration Record Of Injector

Annexure – 4    :  Format For Calibration Record Of Detector

ANNEXURE – 1

FORMAT FOR CALIBRATION RECORD OF HPLC

REF. SOP NO.:	Revision No.:  00	Page No.: 1 of 1
	Effective from:

Calibration Record     :           High Performance Liquid Chromatograph

Instrument No.           :

Make And Model       :

Calibration Date         :

Calibration Due On    :

Calibration Of Pump (Flow Rate):

Flow rate adjusted to 1.0 ml / min.	Observed weight in gm.				Limit in ml / min.
	1	2	Mean wt. / min	Mean Vol. / min
Pump-A
Weight of beaker + water after 10 min. (W2)					0.99 to 1.01
Weight of beaker (W1)
(W2 – W1) / 10
Pump-B
Weight of beaker + water after 10 min. (W2)					0.99 to 1.01
Weight of beaker (W1)
(W2 – W1) / 10

Weight per ml of water =        ________ gm.

Calibrated By:                                                            Checked By:  

Date                                                                            Date : 

ANNEXURE – 2

FORMAT FOR CALIBRATION RECORD OF HPLC

REF. SOP NO.:	Revision No.:  00	Page No.: 1 of 1
	Effective from:

Calibration Record     :           High Performance Liquid Chromatograph

Instrument No.           :

Make And Model       :

Calibration Date         :

Calibration Due On    :

Calibration Of Gradient Proportionate Valve

Parameters :

Mobile Phase              : Reservoir  A 100% Water with HPLC

Reservoir B 0.3% Acetone HPLC 

Wavelength                 : 254 nm.

Flow rate                     : 2 ml / min.

Tine Range	Height From Base Line To B Concentration Peak.	Value Obtained	Actual Value Set In The Program
0.01 To 10.0		(Lt: 9.9 To 10.1)
10.01 To 20.0		(Lt: 49.5 To 50.5)
20.01 To 30.0		(Lt: 89.1 To 90.9)

Value  :      Height of B Concentration

                             --------------------------------------  

                  Height of a 100 % Concentration              

Remarks:    Satisfactory  / Not Satisfactory

Calibrated By:                                                            Checked By:  

Date                                                                            Date :

ANNEXURE – 3

FORMAT FOR CALIBRATION RECORD OF HPLC

REF. SOP NO.:	Revision No.:  00	Page No.: 1 of 1
	Effective from:

Calibration Record     :           High Performance Liquid Chromatograph

Instrument No.           :

Make And Model       :

Calibration Date         :

Calibration Due On    :

Calibration Of Injector : 1. Check for Precision:

Standard Preparation:

Take ______ mg of Uracil (about 50 mg) à 250 ml. à 5ml à 50ml with Methanol.

Parameters:

Mobile Phase : Methanol HPLC grade.       Column  :  ODS (150 mm x  4.6 mm. 5 micron)

Wavelength  :  254 nm.      Flow rate :  1 ml / min.    Injection volume : 20 ml.

Inject six replicate injection of standard solution and calculate RSD for area of main peak.

Injection no.	Area	% of RSD	Limit
1			Not More Than 1.0 %
2
3
4
5
6

2.Check for Linearity :

Sr. No.	Injection volume	Area	Mean	Correlation coefficient
				Observed results	Limit
1	10 ml.	i)  ii)			Not less than 0.99
2	20 ml.	i) ii)
3	30 ml.	i) ii)
4	40 ml.	i) ii)
5	50 ml.	i) ii)

Remarks: Satisfactory / Not satisfactory.

Calibrated By:                                                            Checked By:  

Date                                                                            Date :

ANNEXURE – 4

FORMAT FOR CALIBRATION RECORD OF HPLC

REF. SOP NO.:	Revision No.:  00	Page No.: 1 of 1
	Effective from:

Calibration Record     :           High Performance Liquid Chromatograph

Instrument Sr. No.                  :

Make And Model       :

Calibration Date         :

Calibration Due On    :

Calibration Of Detector

Standard Preparation:

Take _____ mg of Uracil ( about 50 mg.) à250 ml. à 5ml à 50ml with Methanol.

Parameters:

Mobile Phase:  Methanol HPLC grade       Column:  ODS (150 mm x 4.6 mm. 5 micron)

Wavelength:  252- 264 nm with 2 nm increment.      Flow Rate:  1 ml / min.    Injection Volume: 20 ml.

Sr.No.	Wavelength (nm)	Area	Mean
1	252	1) 2)
2	254	1) 2)
3	256	1) 2)
4	258	1) 2)
5	260	1) 2)
6	262	1) 2)
7	264	1) 2)

Largest peak response is observed at __________ nm. (Limit: 258 nm  ± 2 nm)

Remarks: Satisfactory / Not Satisfactory.

                                 

Calibrated By:                                                            Checked By:  

Date                                                                            Date :