SOLITAIRE PHARMACIA PVT. LTD.

  1. Objective

To define the procedure for Operating and Calibration procedure ofK.F. Autotitrator.

  1. Scope

This procedure is applicable to Quality Control departmentatSolitaire Pharmacia Pvt. Ltd., Baddi.

  1. Responsibility

Executive Quality Control

  1. Accountability

HeadQuality Control

  1. Procedure
  1. Instrument Detail:

Name / K.F.Autotitrator
Make / Esico
Model / 1780
Sr. No. / 1002030
Instrument ID. / Location
QCD/KFA/007 / Chemical Lab.
  1. Operation Procedure:
  1. Ensure that instrument is clean and free from dust.
  2. Switch “ON” the main.
  3. System then perform self test for neutralization.
  4. Press “CAL” it will display as CAL – 25.
  5. Press “Enter” for inject. After completion of Neutralization a beep sound will appear.
  6. Operation Procedure for Water Factor:
  7. After completion of Neutralization press “CAL”
  8. Press “Enter” twice display will show : H2O.
  9. Press “Enter” >enter weight of water drop >then press enter for injection.
  10. After completion of titration a beep sound will appear.4.3.5Press “%” for result .
  11. Operation Procedure for Water Content:
  12. After gating water content, press “SPL”.
  13. Enter the weight of sample.
  14. Press “Start”.
  15. After completion the titration a beep sound will appear.
  16. Press “%” for result, result will appear in % in Display.
  17. Take properly entry of water factor and water content on log book.
  18. Calibration Procedure:
  19. Neutralize the water in methanol by Karl Fischer Autotitrator (Use procedure 5.2).
  20. Weigh accurately 100 mg of sodium tartrate dihydrate as a standard. Add into the titration flask and titrate. Record the volume required for the sample.
  21. Take three reading and record obtained results by Karl fisher Autotitrator.
  22. Calculate the average water equivalent factor of Karl Fischer reagents.
  23. Standard value of titrer factor is 6.0 limits: ± 0. 5
  24. Fill the data.
  1. Records/Formats:

SPL/QC/043-Log book for Water factor.

SPL/QC/044-Log book for water content.

SPL/QC/045-Format for Calibration of Autotitrator.

  1. Annexure:

NA

  1. Reference:

Nil

  1. Abbreviations:

SPL-Solitaire Pharmacia Pvt. Ltd., Baddi

QC-Quality Control

SOP-Standard Operating Procedure

  1. Revision History:

Revision No / Effective date / Reason for Revision
00 / New Document

Format No.SPL/QA/001

SOLITAIRE PHARMACIA PVT. LTD.

Log book for Water factor

Format No : SPL/QC/043

Sr. No. / Date / Product Name / Batch No. / Operation Time / Operated By / Check By / Remarks
On Time / Off Time

Log book for Water Content

Format No : SPL/QC/044

Sr. No. / Date / Product Name / Batch No. / Operation Time / Water Factor / Water Content / Operated By / Check By
On Time / Off Time

Format for Calibration of Autotitrator

Format No : SPL/QC/045

Date of Calibration:Next Due Date:

Name of Instrument:Autotitrator

Make:Esico

Model No.:1780

User Department:Quality Control

Sensitivity:0.001 mg/ml

Instrument Code:QCD/KFA/007

Calibration Schedule:Monthly

Environmental Parameter:Temperature 25oC

Sr. No. / Factor / Wt. of di-Sodium Tartrate
( in mg) / Volume Consumed
( in ml) / Water Content
01
02
03
Average
% RSD

Remark: The instrument is working/ not working under satisfactory condition.

Analyzed By:Checked By:Approved By:

Date : Date : Date :

Format No.SPL/QA/001