SOP for Performance Check of Autodiluter : Pharmaceutical Guidelines

SOP for Performance Check of Autodiluter

Standard operating procedure to calibrate Autodiluter used to dilute the solutions in pharmaceuticals.

1.0 Objective

To check the performance of Autodiluter.

2.0 Scope

This procedure is applicable to calibrate Autodiluter.

3.0 Responsibility

3.1 Doing: Technical Assistant
3.2 Checking: Executive /Manager

4.0 Accountability

Head of the Department

5.0 Procedure

5.1 Frequency: once in a 3 months
5.1 Clean the instrument with a dry cotton cloth.
5.2 Operate the instrument as per S.O.P.
5.3 For Right syringe (B)
5.3.1 Take five empty beaker, they should be conditioned & weigh previously.
5.3.2 Suck 100µl with the right syringe (B) & Note down the water weight. Further take 200µl, 300µl, 400µl & 500µl & Note down the water weight.
5.3.4 Check the linearity as shown in Annexure-I.
5.4 For left syringe (A)
5.4.1 Take five empty beaker, they should be conditioned & weigh previously.
5.4.2 Suck 1 ml with the left syringe (A) & note down the water weight.
5.4.3 Further take 2 ml, 3 ml, 4 ml, & 5 ml and note down the weight.
5.4.4 Check the linearity as shown in Annexure –II.

6.0 ABBREVIATION

6.1 μl = Microliter
6.2 ml = Millilitre

ANNEXURE –I
Q. C. Department 
PERFORMANCE CHECK RECORD FOR AUTODILUTER
Name of Instrument :Ref No. :
Make :
Issue Date :
Model No. :Issued By :
Id. No. :


For Right Syringe (B)
Sr. No.
Volume
Wt. Of water in mg
Linearity
1
100 µl


2
200 µl

3
300 µl

4
400 µl

5
500 µl



Linearity : Limit : NLT 99.0%
Remarks :
Calibration date :
Calibration due date :
Calibrated by :
Checked by :

ANNEXURE –II
Q. C. Department 

For Left Syringe (A)
Sr. No.
Volume
Wt. Of water in mg
Linearity
1
1 ml


2
2 ml

3
3 ml

4
4 ml

5
5 ml



Linearity : Limit : NLT 99.0%
Remarks :
Calibration date :
Calibration due date :
Calibrated by :
Checked by :





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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