1.OBJECTIVE
To describes standard operating procedure for Internal Adjustment for Micro Analytical weighing of materials using Micro Analytical Weighing Balance XPE56 (Mettler Toledo).
2.SCOPE
It is applicable for weighing of materials in Weighing Section of QC Lab.
3. ROLES & RESPONSIBILITIES
|
Responsibility |
Tasks |
|
QC Analyst/User/Technical Staff |
Responsible to perform all the training activities per the SOP and to maintain and record all the activities as per the SOP. |
|
QC Analyst/Deputy QC manager |
Responsible to write/review the SOP in coordination with the analyst/user and to update the SOP for more GLP Compliance. |
|
QC Manager |
Responsible to check the SOP as per the prescribed SOP format and to ensure the implementation of all activities as per SOP. |
|
QA Manager |
Responsible to Supervise all the technical procedures as per SOP |
|
Quality Head/Plant Head |
Responsible to authorize the SOP and to verify the implementation of all activities as per SOP. |
|
Task |
Responsibility |
|
Installation |
Service Engineer/ Supplier |
|
Transportation |
DMO/Service Engineer |
|
External Calibration |
Service Engineer/Vendor |
|
Daily Verification |
Analyst /DMO/ Service Engineer |
|
Preventive maintenance |
Analyst /DMO/ Service Engineer |
|
Service |
Service Engineer/Vendor |
|
Operation |
Analyst |
4.Terms & Definitions
- SOP: Standard Operating Procedure
- QMS: Quality Management System
- GLP: Good Laboratory Practices
- Calibration: To align a measurement equipment to read/measure according to a traceable standard equipment under controlled conditions.
- Verification: To Check the performance of a measurement equipment.
5.INTERNAL ADJUSTMENT
Screen shown in the below mentioned picture will be appeared as main screen.
- From main screen touch “Adjust.int” key for internal adjustment.
- Take print out and press “OK” key to proceed further and attach copy in respective log book.
- Daily or pre-use Verification checks:
- Daily or pre-use verification of the analytical weighing balance will be performed by authorized competent staff member.
- If the balance is turned off, verification is required again after switching on the balance.
- Following is the procedure for daily validation
- Balance has separate keys for zeroing and taring.
- If the container is used for weighing the balance must first set to zero by pressing the zeroing key.
- Place the container on balance.
- Press the taring key.
- The weight of container will set as new tare weight and now you can weigh the required substance.
- When the small ring display on left side of display screen disappear, it indicates stability of the balance.
- Press header key to take print of header.
- Place a dead weight on the container after disappearance of un-stability ring on left side of screen press print key to take its print.
- Then place dead weights on container one by one after taring the pan and record their weights by print.
- At the end press footer key.
- After signing this slip attach this slip to verification log book and record the weights .
- Report if the values do not fall within the mentioned reference limit.
6. Flow chart
7. Preventive Maintenance and Cleaning
- Check verification log book for verification data before start weighing.
- Periodically clean the weighing pan with the brush supplied with it and can be cleaned with mild cleaning agent.
- Environmental conditions are ambient temperature 5 to 40 ֯C.
- Doors of weighing area should be closed during weighing process.
- Rapid circulation of air should be avoided in the weighing area. Avoid using shaker, sonicator, magnetic stirrer, centrifuge machine and grinding of tablet in vicinity or on the same desk.
- At least 120 min. after connecting the balance to the power supply; when switched on from standby-mode, the balance is ready for operation.
- “DO NOT” weigh anything directly on the pan.
- Use clean and dry spatulas and weighing containers.
- “DO NOT” change weighing balance location even not within the same room /lab. In form authorized member for this.
8. PRECAUTIONS
- The balance must be installed in a proper place to ensure safe and accurate measurements.
- Installation site should be straight and bubble should be adjusted in center by screwing up and down the levers.
- Avoid the following types of sites.
- Sites with air currents from air conditioner, ventilators, open doors or windows.
- Sites with vibrations.
- Sites in direct sunlight.
- Sites with extreme temperature changes or with high / low temperature or sites with high/ low humidity.
- Sites near flammable and corrosive gases.
- Sites with dust, electromagnetic waves, or magnetic fields.
- The glass doors open backwards beyond the rear end of the main body, make certain enough space is available to open the doors.
9. TROUBLESHOOTING
Calibrate and verify the instrument again if instrument is not showing stable reading. Call the service provider if issue persist.
External Calibration of equipment is done annually or in the following conditions.
When the location of the installation site is changed. When abnormal behavior is noted during weighing or daily verification.While verification should be done on daily basis for proper functioning of weighing balance
10. Related Documents
- Analytical Balance Utilization Log Book
- Weighing Balance Verification Log Book
11.References:
- Manual of XPE56 (Mettler Toledo)