Learn the complete SOP for Performance Check of Autodiluter used in pharmaceutical laboratories. Step-by-step calibration procedure, frequency, responsibilities, and linearity checks explained.

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SOP for Performance Check of Autodiluter in Pharmaceutical Laboratories

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Learn the complete SOP for Performance Check of Autodiluter used in pharmaceutical laboratories. Step-by-step calibration procedure, frequency, responsibilities, and linearity checks explained.

SOP for Performance Check of Autodiluter

In pharmaceutical laboratories, maintaining precision and accuracy during solution preparation is critical. The SOP for Performance Check of Autodiluter ensures that the instrument used for dilution delivers consistent and reliable results. This standard operating procedure (SOP) outlines the objective, scope, responsibilities, and detailed steps required to calibrate and verify the performance of an autodiluter.

Regular performance checks help maintain compliance with regulatory standards, improve data integrity, and prevent analytical errors.

1.0 Objective

The objective of this SOP for Performance Check of Autodiluter is to verify the accuracy, precision, and linearity of the autodiluter used for diluting pharmaceutical solutions.

2.0 Scope

This procedure is applicable to all autodiluters used in pharmaceutical laboratories for solution preparation and dilution activities.

3.0 Responsibility

Execution (Doing): Technical Assistant
Review (Checking): Executive / Manager

4.0 Accountability

Head of the Department

5.0 Procedure

5.1 Frequency

The performance check of the autodiluter shall be carried out once every three (3) months.

5.2 Pre-Operational Cleaning

Clean the external surface of the instrument using a dry, lint-free cotton cloth.
Ensure the work area is clean and free from contamination.

5.3 Operation

Operate the autodiluter strictly as per its approved operating SOP.
Ensure distilled or purified water is used for calibration purposes.

5.4 Performance Check – Right Syringe (B)

Take five empty beakers.

Ensure they are properly conditioned.

Weigh and record the empty weight of each beaker.

Using the right syringe (B), aspirate and dispense:

100 µL – Record the water weight.
200 µL – Record the water weight.
300 µL – Record the water weight.
400 µL – Record the water weight.

500 µL – Record the water weight.

Calculate and verify the linearity by comparing theoretical weight vs. actual weight.

5.5 Performance Check – Left Syringe (A)

Take five empty, conditioned beakers.

Record their pre-weighed values.

Using the left syringe (A), aspirate and dispense:

1 mL – Record the water weight.
2 mL – Record the water weight.
3 mL – Record the water weight.
4 mL – Record the water weight.

5 mL – Record the water weight.

Evaluate linearity by plotting or comparing expected vs. observed values.

Importance of SOP for Performance Check of Autodiluter

Implementing a structured SOP for Performance Check of Autodiluter ensures:

Accurate volume delivery
Reliable dilution of pharmaceutical samples
Regulatory compliance (GMP standards)
Reduced analytical errors
Improved laboratory data integrity

Routine calibration and performance verification protect the credibility of laboratory results and ensure patient safety.

Frequently Asked Questions (FAQ)

1. What is the purpose of the SOP for Performance Check of Autodiluter?

The purpose is to verify the accuracy, precision, and linearity of the autodiluter to ensure reliable dilution of pharmaceutical solutions.

2. How often should the performance check of an autodiluter be performed?

The autodiluter performance check should be conducted once every three months, or as per internal quality requirements.

3. Why is linearity testing important in autodiluter calibration?

Linearity testing confirms that the instrument delivers proportional and accurate volumes across different ranges, ensuring consistency in dilution results.

4. Who is responsible for performing and reviewing the autodiluter performance check?

The Technical Assistant performs the procedure, while the Executive or Manager reviews and verifies the results. The Head of the Department is accountable.

5. What happens if the autodiluter fails the performance check?

If the autodiluter does not meet acceptance criteria, it should be recalibrated, serviced if necessary, and requalified before further use.