SOP For Procedure for calibration of Autotitrator (METTLER TOLEDO)

SOP For Procedure for calibration of Autotitrator (METTLER TOLEDO)

  • OBJECTIVE
  • To lay down the procedure for Calibration of Autotitrator  (METTLER TOLEDO DL50).
  • SCOPE
  • This SOP shall be applicable for the Autotitrator (METTLER TOLEDO DL50).
  • RESPONSIBILITY
  • Quality Control Executive/Officer.
  • ACCOUNTABILITY
  • Head Quality Control.
  • PROCEDURE FOR CLEANING
  • Check that the power supply to the instrument is switched ‘ OFF ‘ before cleaning. Clean the instrument with a clean dry cloth every day. Occasionally wet cloth dipped in dilute soap solution may be used. Precaution has to be taken to clean the instrument immediately with dry cloth to remove the moisture.
  • PROCEDURE FOR CALIBRATION:
  • To perform the calibration of instrument as per procedure given below, follow the operating instruction given in the SOP of the instrument.
  • Following parameters shall be calibrated:
  • 1) Dosimat (Burette) Calibration:
  • 2) Electrode Calibration:
  • Dosimat (Burette) Calibration:
  • Fill reservoir bottle with distilled water and fix it into Dosimat.
  • Purge the system two to three times by draining out the distilled water (dispensing procedure).
  • Weigh and tare the volumetric flask then put addition tube of the Dosimat into beaker.
  • Weigh the volumetric flask with distilled water and record the weight by dispensing the volume in sequence of 5, 10, 15 and 20ml.
  • Divide each weight observed with 0.99602-factor and record volume obtained.
  • The following is the volume in ml and the tolerance range for the volumes taken
Volume in ml Tolerance
5.0 4.95 to 5.05
10.0 9.90 to 10.10
15.0 14.85 to 15.15
20.0 19.80 to 20.20
  • Electrode Calibration:
  • Perform the pH calibration with the USP Buffers of pH 4.00 and pH 7.00. Prepare the buffers as per USP to perform the calibration, select the user methods by pressing =. Press ok.
  • Fill two titration vessels with the pH 4.00 and pH 7.00 buffers respectively.
  • Select the method No.10 (Calibration pH Electrode), Press Modify and Feed the desired parameter as pH 4.00 and pH 7.00 and press ok. Keeping fixed volume as 50 ml.
  • Connect the electrode DG 111 and immerse in the solution.
  • Fasten the vessels containing the pH 4.00 and pH 7.00 one after another. Go to flask symbol; go to the method (Calibration pH Electrode) Then press Run to start the test.
  • The instrument is ready for a 2-point calibration. On request of confirmation press Start. After completion of the first point calibration, the pH of the first buffer is measured.  When the measured value has met the Set drift criteria, the measurement is stopped.
  • The instrument is ready for the next calibration. Remove the first vessel.
  • Clean the glass electrode with distilled water and absorb off the excess water using a tissue paper.
  • Fasten the second buffer solution and press start. After completion of second buffer calibration take printout.
  • The acceptance criterion for Electrode calibration is slop should be between –52.0 mV to –65.0 mV / pH fill the calibration details in instrument log book.
  • The Autotitrator that fails to meet the Calibration limits is declared OUT OF ORDER and inform to Service Engineer.
  • After necessary repairs the Autotitrator is recalibrated before use.
  • After the completing of titration, the solution is discarded and the titration vessels are rinsed with water, washed and dried.
  • Store all the electrodes in the respective storage solution.
  • Empty the Titration vessel with the knob provided on the instrument in the waste bottle and the waste is discarded  under the running tap water.
  • Forms and Records (Annexures)
  • Calibration of Auto Titrator (Metler Toledo DL 50) – Annexure-1
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control.engineering
  • History
    Date Revision Number Reason for Revision
    00 New SOP

Annexure-1

Instrument Calibration Format – Autotitrator Mettler Toledo DL-50

Location   Calibration procedure no.
Make Mettler Toledo Instrument id. No. 2QA050
Model no. DL-50 Effective Date

Cleanliness Of Equipment / Instrument Before Calibration:  Satisfactory/ Not Satisfactory

  1. Dosimat (Burette) Calibration:

Volumetric Flask Used: ———————(ml)                        Code No: ——————————-

Wt Per ml Of Water At 25°C:  0.99602

Dispense Volume

(ml)

Wt of empty Volumetric Flask

(W1) g

Wt of filled Volumetric Flask

(W2) g

Actual Dispense Volume in gm

(W2-W1) (g)

Vol. dispense (V) in ml

V = (W2-W1) / Wt per ml of water At 25°C

Tolerance

(ml)

5.0 4.95 – 5.05
10.0 9.90 – 10.10
15.0 14.85 – 15.15
20.0 19.80 – 20.20
  • Status: ­­­­­­­­­­­­­­­­ Pass/ Fail
  • Electrode Calibration:
  • Electrode: DG111SC
Buffer Standards

 (pH)

Observed Value

(mV)

Slope Value

mV/pH

Acceptance Criteria
4.0 -52.0 mV to –65.0mV/pH
7.0
  • Status: ­­­­­­­­­­­­­­­­ Pass/ Fail
  • Opinion: instrument is suitable/ not suitable for use
  • Next Calibration Due On: ­­­————————————————————–
  • Calibrated by:                                                Checked by:                                             Approved by:
  •  Date      :                                                        Date       :                                                   Date

 

For More Pharma Updates Visit –https://pharmaguidances.com

About Pharma Editor

Check Also

SHELF LIFE EXTENSION OF EXISTING COMMERCIALIZED PRODUCTS

SHELF LIFE EXTENSION OF EXISTING COMMERCIALIZED PRODUCTS PURPOSE: To define a procedure for shelf life …