Stabicon Life Sciences Pvt Ltd

Standard Operating Procedure Operation, maintenance and calibration of weighing Balance Model PB1501L Instrument Number: E-037

Document Identity : SLS-MIC.032.01

Function Author Signs for Review Signs for approval & release Issue date: Effective Date

Role Manager Microbiology Head Analytical Manager Quality Assurance

Name V.Rajesh Dr. U.R. Anil Kumar

Date

Signature

M.Bala Kishore

Sign

Next Review Date

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SLS-MIC.032.01

1.0

Purpose To provide a standard operating procedure for operation, maintenance and calibration of Mettler weighing Balance used in Microbiology department of Stabicon life sciences.

2.0

Scope This procedure is applicable for Mettler weighing Balance, Model PB1501L used in Microbiology department of Stabicon life sciences .

3.0

Responsibility Microbiologist shall be responsible to implement this procedure. Laboratory manager shall be responsible to supervise the operation, maintenance and calibration of Mettler weighing Balance.

4.0

Procedures 4.1 System set up 4.1.1 The Balance has a spirit level and two adjustable leveling feet to compensate for slight irregularities in the surface of the weighing bench. The balance is exactly horizontal when the air bubble is in the middle of the level glass. 4.1.2 Adjust the two leveling feet appropriately until the air bubble comes to rest exactly in the middle of the glass. 4.1.3 The balance should be leveled and adjusted each time it is moved to a new location. 4.1.4 Connect the power supply as per manufacture specifications. 4.2 System operation 4.2.1 Once system set up is over, Plug the AC adapter into the AC adapter socket on the balance, and connect to the power supply. 4.2.2 The balance will display OFF, wait for 30 mins to stabilize the balance and perform the daily calibration. 4.2.3 Sample weighing : Place empty container on the balance and the weight is displayed.
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Press the O/F key briefly for taring. Wait until the stability detector disappears. Add weighing sample to container and the Wait until the stability detector disappears.

Press the print command on the printer and results will be printed out.

4.2.4 Switching off : Press and hold the Off key down until OFF appears in the display and Release the key. 4.2.5 Menu operation : Press and hold down the Cal/Menu key until MENU appears in the display. Release the menu key option is displayed. Change settings: The (F) key is used to change the setting at the selected menu option. Every time the key is pressed, the next setting is displayed. Once the desired setting appears in the display, the next menu option can be selected or close the menu Reset balance settings: Select Reset, press and hold down the Cal/Menu key until the message r donE appears. It confirms that all menu settings have been reset. Recording balance settings: Select List and hold down the Cal/Menu key until the message StorEd is displayed. The current balance settings are transmitted to the peripheral device connected to the interface. The balance has an RS232C interface for connection to a printer. Printer: Connect to printer and press the date/time option to enter the date and time. Press the Cal/Menu option to take the print out. 4.3 Precautions 4.3.1 The balances must not be operated in hazardous areas with the standardsupply AC adapter.

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4.3.2 4.3.3 4.3.4 4.3.5

Before connecting the AC adapter, verify that the voltage printed on it corresponds to the local mains voltage. The balances may only be used indoors in a dry environment. The balance should be placed in stable, vibration-free position as horizontal as possible. To avoid direct sunlight, excessive temperature fluctuations.

4.4 Maintenance 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5 4.4.6 The weighing pan shall be cleaned after the usauage with mild detergent. After weighing the chemicals, it is advisable to wash or clean the weighing pan and the bottom plate. Ensure there is no liquid comes into contact with the balance or the AC adapter. Soiled protective covers can be replaced when its damage. Record the usuage in form No.1. The major preventive maintenance and trouble shooting shall be performed as per the operation manual. 4.5 Calibration 4.5.1 4.5.2 To obtain accurate weighing results, the balance must be calibrated to match the gravitational acceleration at its location. The calibration is necessary in following conditions : Before the balance is used for the first time on a day. At regular intervals during weighing service. After a change of location Procedure : The balance must be connected to the power supply for 30 minutes in order to reach operating temperature before adjusting. The required adjustment weight shall be kept ready. Unload the weighing pan. Press and hold the Cal/Menu key down until CAL appears in the display, then release the key.

4.5.3

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4.5.4

The required adjustment weight value flashes in the display. Place adjustment weight in center of pan and the balance adjusts itself automatically. When 0.0 g flashes, remove the adjustment weights. The calibration is finished when the message CAL done appears in the display, followed by 0.0 g. The balance is again in weighing mode and ready for operation.

Frequency The requirements of calibration are divided by various time intervals, where each of the time intervals requires certain specific steps to be performed. The time intervals are broken down as follows Daily schedule (Accuracy) Monthly schedule(Repeatability) Annual schedule(External calibration,Linearity, Eccentricity, Hysteresis)

4.5.5

Daily schedule Accuracy check is performed daily before use and recorded it in Form.No.2. The calibration shall be performed as per section 4.6.3. Balance accuracy is checked with a set of calibrated reference weights. Check with minimum (100g), medium (500 g) and maximum (1000g) range weights. Acceptance criteria: +/- 1% of the weighed reference weights.

4.5.6 Monthly schedule The Precision check shall be performed on monthly basis and recorded it in Form.No.3. The calibration procedure shall be followed as per section 4.6.3. Repeatability: Weigh 10 times each of the following weights - 10 g, 500g, and 1000g. Calculate the Standard deviation. The standard deviation should be less than 0.08 for the recorded weight.

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4.5.7 Annual schedule(External calibration) The accuracy of the balance are determined and adjusted as required by an external professional service contractor. The reference standard weights are singularly calibrated on Annul basis by external agency.

Linearity : Sequentially place standard weights 2g, 5g, 10g, 20g, 50g, 100g, 200g, 500g, 1000g and 1500g on the pan and note the displayed readings. Calculate the std. deviation and correlation coefficient. Acceptance criteria: A Std.deviation of <=0.1g for each weight is allowed. The correlation coefficient should be NLT 0.998. Test of position independence: (Eccentricity) Follow the procedure used for accuracy and precision. Since the maximum error will occur with large weights placed far from the center of the pan, tabulate the labelled and observed values for different extreme positions of the weight as well as for the latter at the center of the pan. (Note: the weight used should be close to the maximum capacity for the balance e.g. 1000 g for 1510g capacity). Acceptance Criteria: A Std. Deviation of +/-0.08g. The External Service Contractor prepares and attaches their

calibration/expiration label. Hysteresis To verify the hysteresis of the balance the following method is to be followed.Note: Mechanical hysteresis occurs when the springs are subjected to excessive lengthening due to overload/mechanical shock. Similarly magnetic hysteresis occurs with electromagnetic force compensation systems. Such hysteresis is taken care of in properly designed systems.

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SLS-MIC.032.01

Switch ON the balance. Allow it to stabilize for about 30 minutes. Now tare the balance. In this test after taring the empty pan, place the maximum permitted weight on the pan. Note the reading. Remove the weight and note the reading.

Repeat the procedure six times without taring again and note the deviation each time from the initial tare value. The cumulative deviation from zero indicates the hysteresis over several cycles. The mean deviation per cycle may be calculated therefrom.

5.0 6.0 References Operator Manual Abbreviations

Acceptance Criteria: For a good balance the hysteresis Std Deviation is less than +/- 0.08g or that specified by the manufacturer.

Abbreviation SLS MIC SOP g 7.0 Attachments

Number Quality record generated Form 1 Balance usage record

Explanation Stabicon Life Sciences Microbiology Standard Operating procedure Gram

Quality record No.

MICF032 MICF032 MICF032

Location
QA documentation cell QA documentation cell QA documentation cell

Form 2 Form 3

Daily calibration record Monthly calibration record

8.0 History
Sl. No. Date CCR No. NEW Current SOP. Version SLS-MIC.032.01 Supersedes NA Reason NEW SOP

END OF DOCUMENT
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