Microscope – Operation & Calibration Procedure

Standard Operating Procedure (SOP) for operation & calibration of digital microscope. A microscope consists of a compound magnifying system in which the observer looks at the first (primary) image with a lens that produces an enlarged secondary (virtual) image.

Microscope – Operation & Calibration

1.0   Purpose:

    • To lay down the procedure for operation and calibration of digital microscope Motic BA210.

2.0   Scope:

    • This Standard Operating Procedure is applicable at microbiology section of Quality Control department.

3.0   References & Definition:
Microscope

    • References:
    • Operating Manual of Digital Microscope.
    • What is Microscope (Definition, Principle , Usage) :

    • A microscope consists of a compound magnifying system in which the observer looks at the first (primary) image with a lens that produces an enlarged secondary (virtual) image.
    • The two convex lenses are aligned in such a way that the observer sees an enlarged image of an object.
    • The resolving power (also called resolution) of a microscope is the smallest distance between two separate dots that allows the viewer to differentiate two dots from a single dot.

4.0   Procedure – Handling of Digital Microscope:

    • Cleaning of Lenses – Digital Microscope

    • To clean the lens surface, remove dust using tissue paper.
    • Use tissue paper moistened with absolute alcohol to remove finger marks, oil and any kind of dust.
    • For cleaning of objective & oil immersion lenses use tissue paper moistened with Xylene.
    • Cleaning of Painted Surface

    • Avoid use of any organic solvents (e.g., Xylene, ether, alcohol) for cleaning the painted surfaces and plastic parts of the instruments.
  • Operation of Microscope (Motic BA210)

    • Login:
    • VI-Connect Exe available in desktop, double click on VI-Connect Exe icon, then VI Connect Software get started, and showing you login page for logging in Software.
    • Enter your User ID and press Enter key, you can see your User Name, then enter you Login Password and click on login button. (Login Password and Transaction Password are different).
    • For every wrong password, Login attempt gets deducted by 1. After correct password, login count start with login count set by administrator.
    • After successful login, see main page having menus.
    • Click the Pharma Grade ADD / List / Review:
    • Pharma Grade Add New: For this, Login User and follow the path-

MasterPrimary Master ⇒Pharma Grade ⇒Add New

    • Enter Pharma Grade Name like IP, BP and enter Pharma Grade details like IP for Indian Pharma.
    • After all details fill, enter Password and click on Save and then the particular Pharma Grade Name will be added and display in grid with details.
    • Pharma Grade List: For this, Login Reviewer and  follow the path-

Master ⇒Primary Master ⇒Pharma Grade ⇒List

    • Pharma Grade Review:

    • Review all added pharma grade, without review it is not available for any use. For this, Login as Reviewer and follow this path-

Master ⇒Primary Master ⇒Pharma Grade ⇒Review

    • Select Record from the List.
    • Select Accept / Reject option from the List.
    • Give Remark and Save the Record with Transaction Password.
    • After Review, you can only make Pharma grade discontinues.
    • Click the Item Name Add / List and Review:

    • For Item Name add-
    • Item Code Add New: To go to this form, Login as User and Follow the Path-
    • Master ⇒Primary Master ⇒Item Code ⇒Add New
    • Select Item/Product Type, fill Item Code and press tab key it will display already added item name under that item code if available.
    • Fill item name and with the transaction password, click on Save.
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    • For Item Name List (for Modification)
    • Item Code List / Modify: To go to this form, Login as Reviewer and follow the path-
    • Master ⇒Primary Master ⇒Item Code ⇒List
    • Enter Item/Product Code which you have added previously and press tab key it will display all added item name under that item code in the grid.
    • In the gird all the information display if we want to modify any item name then select that record and click on modify button.
    • Item Code Add New: To go to this form, Login as Reviewer and follow the path-
    • Master ⇒ Primary Master ⇒ Item Code  Review
    • After click on Modify Button, selected Record available for Modify.
    • You can change Item Name, make any Item Discontinue by checking Check Box for Discontinue.
    • Click the Test Master Add/Review/Approval: In Transaction part we add Test Master require for Calibration.
    • Test Master: For this, Login User and Follow the path-

Transaction ⇒ Test Master   Add New

    • Select Instrument/Equipment Name and press tab key, it will show already entered Make name.
    • Select Make Name and press tab key, it will display already added model name in grid.
    • Obtain Model Name from grid, by double click on same.
    • Fill IOP no., Version no. and click on ADD Master, Test Master Number get Auto generated.
    • Select Objective and enter Dimension for X-axis and Y-axis.
    • Enter Min Limit and Max Limit for selected objective and press tab key.
    • In Limit Text Box you see the Limit Format, Which you can be Modify.
    • This Format is displayed on Calibration Certificate.
    • Enter Number of Decimal, which restrict your Result to defined Decimal and same is displayed on Report.
    • After filling all mention Information save the Record.
    • Saved Record Displayed in Grid.
    • Follow the same procedure for all objective
    • After selecting Acceptance Criteria for all objectives, submit the record for Review.
    • Test Master Review: For this you have to Login Reviewer and follow the path-

Transaction  Test Master   Review

    • In this form it will display all the added IOP’s for review.
    • Select the IOP no. to review fill the remark and enter the password and click on Save and then the particular IOP No. will be Review.
    • If any details goes wrong during addition of Test master then modify the record at review stage so if we want to change the details select that record and click on modify Button.
    • Test Master Approval: For this, Login Section Head and follow the path-

Transaction  Test Master  Approval

    • Select the record from grid of Test Master.
    • It will display Select option for Accept or Reject.
    • As per Record, select any option and save the Record with Transaction Password and give proper Justification for Reject.
    • Test Master Acceptance: For this, Login Final Approval and
    • Follow the path-

                           Transaction ⇒ Test Master  Final Acceptance, it will open following form:

    • As it display Approved as well as Rejected Test master, Select the record from grid of Approved Test Master, so that it will display justification and authentication to accept or reject the IOP no.
    • For Reject, fill justification or Accept without justification and with password approve the record.
  • Calibration of Microscope :

    • Click the Calibration Schedule: Calibration schedule is generated by Section Head and for this follow the path-

Transaction ⇒ Schedule ⇒ Add New.

    • Select Instrument Code and press tab key.
    • Verify details.
    • Select from Date & to Date and the Frequency to generate a schedule for selected period.
    • Type the Deviation Days and click on Show. Deviation Dates are calculated as Start Date – Deviation Days.
    • Delete Unwanted Schedule and submit the record with Transaction Password

Related: Steam Sterilizer – Operation and Calibration

    • Make schedule discontinue by using Discontinue option. (Schedule  Discontinue).
    • Calibration A.R. No. Allocation: We can prepare A.R no. in two way:
    • Schedule-wise: For this, Login Section Head and Follow the path
    • Microscopy ⇒  Transaction ⇒  A.R No. Allocation ⇒  Schedule wise, and Login with Authorized User who have rights for A.R no. Allocation.
    • Select From Date and To Date and press tab key.
    • Select particular Record from the list and Verify IOP Number and version number.
    • Non-Schedule-wise: For this, follow the path-

    • Microscopy ⇒  Transaction ⇒  A.R Number Allocation ⇒  Non-Schedule-wise, and Login with Authorized User who have rights for A.R no. Allocation.
    • Select Instrument Code and click on Show.
    • Click on Show button in front of Model Text box.
    • Select the record from Grid and verify the IOP number.
    • Type A.R Number, select Calibration option.
    • Save the record with Transaction Password.
    • Assign the A.R. No. as MCYYXXXX
    • YY –       Last Two Digit of the Calendar Year.
    • XXXX – 001, 002, 003, ——— to 999
    • For e.g. MC210001
    • Click Perform Calibration:

    • Only work allotted User can perform the Calibration (work allocation done by Section Head).
    • For this, Login as User ( work allocated and having User Authority to perform calibration) and follow the path-

Microscopy ⇒  Transaction ⇒  Microscopy ⇒  Calibration.

    • Type Correct A.R no. and click on Start.
    • Update basic observation i.e. cleanness and any other maintenance.
    • Then Click on Calibration Tab and select Objective form grid and click on Capture Image for Capturing the Image.
    • Capture Window get open and capture the required Image.

                           Note: Your Image Should be saved in .jpg Format

    • Select the same Objective form list and click on Perform Calibration.
    • Calibration Process Should Mentioned By XYZ.
    • After Measurement click on Measured table and save the file in .txt
    • After that save the Image.
    • Result is auto displayed on Calibration Form along with Complies / Does Not Comply.
    • Perform Same Procedure for All Other Objectives.
    • After Performing All Objective submit the A.R No. for Review.
    • Click Calibration Review: For review, Login as Reviewer Calibration Review and follow the path-

Transaction ⇒  Microscopy ⇒  Review.

    • Select calibration option and enter the Correct A.R no. and press tab key.
    • Select the Record.
    • Preview of Instrument Data sheet and Certificate are available.
    • Select approve option as a retest if results are not satisfied.
    • And if results are satisfactory then select Accept option.
    • After Accept, A.R no. goes to Section Head for Approval.
    • Click Calibration Approval:

    • For Calibration Approval, required two approvals for completing calibration-
    • Section Head: Follow the path-
    • Transaction ⇒  Microscopy ⇒  Approval ⇒  Section Head, and required Login of Section Head for Section Head Approval.
    • Enter the Correct A.R no. and Click on Show.
    • Give Remark and submitted it to Final Approval.
    • This Remark is displayed on Calibration Certificate.
    • View Certificate and Data Sheet before Approval.
    • Transaction ⇒  Microscopy ⇒  Approval ⇒  Final Approval, and required Login for Final Approval.
    • Enter the Correct A.R no..
    • Here For Final Approval, see Accepted or Rejected. Calibration Record by Section Head.
    • For Final Approval, give Final approval by Accepting or Rejecting the Accepted or Rejected Calibration Record.
    • Modify Remark by Section Head.
    • View Certificate and Data Sheet before Approval.
    • Analysis A.R. Number Creation:
    • For performing Analysis, Login as User to use Instrument and have User Authority for Analysis.
    • For analysis there is no need to perform Work allocation.
    • Follow the path-

                           Microscopy ⇒  Transaction ⇒  Microscopy ⇒  Analysis

    • Type A.R Number.
    • Enter the no. of Analysis to be performed and click on Start.
    • Type no. of Analysis.
    • Enter the Test Name.
    • Select Sample and click on Capture Image for Capturing the Image.
    • Select Objective form grid and click on Capture Image for Capturing the Image.

Note: Image should be saved in .jpg format

    • Capture Window get open and capture the required Image.
    • Then select Analysis with Capture / Process Image.
    • Analysis Process Should Mentioned By XYZ.
    • After Measurement click on Measured table and save the file in .txt
    • After that save the Image.
    • Perform same procedure for all samples.
    • After performing all samples, submit the A.R no. for Review.
    • For Analysis Review, Login as Reviewer and follow the path-

                           Microscopy ⇒  Transaction ⇒  Microscopy ⇒  Review.

    • Select Analysis option and enter the Correct A.R no. and click on Show.
    • Select the Record and Double click on Sample to Check Preview of Analysis Preview.
    • You can Select approve option as a retest if result are not satisfied.
    • You can send single or multiple Samples for retest.
    • After accepting A.R number, Analysis Part Complete.
    • Review is the Last Approval stage for Analysis.
    • Click Report:
    • For printing Calibration Report-

Use Path Report ⇒  Microscopy ⇒  Calibration.

    • Enter Calibration A.R no. and click on Show.
    • Select the Record from Grid.
    • Select any option from Calibration Certificate or Calculation Data sheet.
    • Click on Preview for Preview of Report.
    • For Print, Use Print Button.

Use Path Report ⇒  Microscopy ⇒  Analysis

    • Enter Analysis A.R Number and click on Show.
    • Select the Record from Grid.
    • Preview the Sample, from Grid by clicking Preview button in Grid.
    • And Take print by using Printer.

5.0   Annexures – Microscope:

Annexure-1 : Operation Record for Microscope.

Instrument ID.:  

Date

Activity A.R. No. Start Time End Time Operated By Checked By

Remarks

Annexure-2 : Calibration Record for Microscope.

Instrument ID.:  
Sr. No. Objective Measurement Observed Value

(length µm)

Limit (length in  µm)
1 4X L1   1425-1575  µm
L2  
L3  
L4  
2  10X L1   570-630  µm
L2  
L3  
L4  
3 40X L1   142.5-157.5  µm

 

L2  
L3  
L4  
4 100X L1   66.5-73.5  µm
L2  
L3  
L4  

Annexure-3 : Calibration Status Label.

 

CALIBRATION STATUS LABEL

Name of Instrument  
Instrument ID  
Calibration On  
Due On  
Calibration By  
 

 

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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