Standard Operating Procedure (SOP) for Balance

Title: Calibration of Analytical Balance

SOP No.: QC/ANL/SOP/001
Effective Date: [Insert Date]
Review Date:
Department:
Prepared by:
Approved by:

1. Purpose

To establish a procedure for the calibration of analytical balances to ensure accurate and reliable
measurement in accordance with USP <41>, USP <1251>, ICH Q2(R1), and USFDA 21 CFR Part
211.68.

2. Scope

This SOP applies to all analytical balances used in the Quality Control department.

3. Responsibility

 QC Analyst: Perform and record calibration.

 QA Officer: Verify and review calibration data.

 QC Manager: Ensure compliance with SOP.

4. References

 United States Pharmacopeia (USP) <41>: Weights and Balances

 United States Pharmacopeia (USP) <1251>: Weighing on an Analytical Balance

 ICH Q2(R1): Validation of Analytical Procedures

 ICH Q9: Quality Risk Management

 USFDA 21 CFR Part 211.68: Automatic, Mechanical, and Electronic Equipment.

5. Definitions

 Repeatability: Precision under the same conditions over a short interval.

 Eccentricity: Accuracy of reading when weight is placed at different pan positions.

 Minimum Weight: Smallest weight that gives repeatable readings with acceptable error.

6. Materials and Equipment

 Calibrated standard weights (Class E2 or F1)

 Balance logbook

 Calibration worksheet

7. Calibration Frequency

 Daily: Internal check with standard weight

 Monthly: Full internal calibration (Repeatability, Eccentricity, etc.)

 Annually: Third-party calibration with certification

8. Procedure

8.1 Environmental Check

 Ensure balance is leveled and stable.

 Record room temperature and humidity.

8.2 Repeatability (USP <41>)

Repeatability is the ability of the balance to provide consistent results when the same weight is
measured multiple times under the same conditions.

It checks the precision of the balance over a short period of time without changing any external
conditions (like operator, temperature, etc.).

Steps to Perform Repeatability Test (As per USP <41>):

1. Choose a standard weight:

Use a calibrated certified weight (e.g., 100 mg weight).

2. Weigh it 10 times:

Place the weight in the center of the pan and record 10 consecutive readings without making any
changes to the environment.

Example Readings (mg):

99.98, 100.01, 99.99, 100.00, 99.98, 100.00, 100.01, 100.00, 100.00, 100.01

6. Acceptance Criteria:

 RSD ≤ 0.10% of the mean weight

 If this condition is met, the balance is considered to have acceptable repeatability.

8.3 Accuracy (USP <41>)

Accuracy refers to how close the balance reading is to the true value (i.e., the known certified
weight).

It shows whether the balance is correctly calibrated and is capable of giving true values.

Steps to Perform Accuracy Test (As per USP <41>):

1. Select certified standard weights

Use weights that are traceable and calibrated (e.g., 10 g, 20 g, 50 g).

2. Weigh each standard individually

Place each weight on the center of the pan and record the observed value displayed by the balance.

3. Calculate % Difference

4. Acceptance Criteria (USP <41>):

The % difference should be within:

Example Calculation

Suppose you are testing a 20 g standard weight.

 Certified Value (Nominal): 20.000 g

 Observed by Balance: 19.998 g

Step 1: Apply Formula

8.4 Linearity (ICH Q2)

Steps to Perform Linearity Test:

1. Select Standard Weights

Choose certified weights that cover the balance range, e.g.:

 10% of full capacity (e.g., 20 g)

 25% (50 g)

 50% (100 g)

 75% (150 g)

 100% (200 g)

(Example shown here for a 200 g capacity balance)

2. Weigh Each Load

Place each certified weight on the pan and record the displayed (observed) value.

3. Calculate Deviation (%)

Use the formula:

4. Acceptance Criteria
5. Plot a Linearity Graph

 X-axis: Nominal Weight

 Y-axis: Observed Value

 Plot a straight line (y = x) and check how close the observed values are to the nominal line.

Linearity Graph

A straight line should result, showing high correlation (R² ~ 0.999 or 1.000) between nominal and
observed values. If the curve bends away, the balance has non-linearity and needs
calibration/service.

8.5 Eccentricity (USP <1251>)

What is Eccentricity (USP <1251>)?

Eccentricity refers to how consistently the balance performs when a weight is placed at different
positions on the weighing pan (center and corners).
A properly calibrated balance should give the same reading no matter where you place the weight —
center or corner.
Why is Eccentricity Important?

 To verify that the balance’s load cell responds uniformly.

 Helps detect mechanical or alignment issues in the pan.

 Required for GMP and regulatory compliance (USP, USFDA).

Eccentricity Test Procedure (USP <1251>):

1. Select a Standard Weight

 Use a single certified weight, ideally equal to 1/3 to 1/2 of the maximum balance capacity.

Example: For a 200 g balance, use a 100 g weight.

2. Position the Weight:

Place the weight on 5 locations:

 Center (C)

 Front Left (FL)

 Front Right (FR)

 Back Left (BL)

 Back Right (BR)

3. Record Observed Values

Take readings at each of the five positions.

4. Calculate the Deviation from Center

Use this formula:

5. Acceptance Criteria:

Each corner’s reading must be within ±0.05% of the center value.

Example Table:

Assume weight used = 100.000 g

If Any Position Fails:

 The balance fails eccentricity.

 May need realignment, servicing, or re-calibration by a technician.

8.6 Drift Check

What is Drift Check?

Drift refers to the change in balance reading over time when the same weight remains on the
weighing pan.

A good analytical balance should maintain a stable reading over time, without “drifting” up or down.

Why Drift Check is Important?

 Ensures the balance remains stable during a weighing session.

 Detects environmental disturbances, such as air drafts, vibrations, or temperature changes.

 Required during balance qualification (Installation Qualification, Performance Qualification)

and routine calibration.

Drift Check Procedure (Step-by-Step)

1. Choose a Certified Standard Weight

 Select a weight within 50–100% of balance capacity.

Example: For a 200 g capacity balance, use a 100 g or 150 g standard weight.

2. Stabilize the Environment

  Ensure the balance is leveled, calibrated, and in a controlled environment (no air flow or
vibration).

 Let the balance warm up as per manufacturer instructions.

How to Level the Balance:

Most balances have:

 A bubble level indicator (a small circular window with a bubble).

 Leveling feet (usually two or four small adjustable legs at the bottom).

3. Place the Weight and Record Readings

 Record the weight reading at time intervals:

o 0 minutes (immediately after placing)

o 5 minutes

o 10 minutes

o 15 minutes

4. Calculate Drift

Use this formula:

Acceptance Criteria

Drift must be within ±0.1%.

If drift exceeds this limit, balance performance is not acceptable and investigation is required.

Max = 100.004 g

Min = 100.001 g

Nominal = 100.000 g

Result: PASS (Drift is within ±0.1%)

8.7 Minimum Weight (USP <41>)

What is Minimum Weight?

The Minimum Weight is the smallest amount of substance that can be weighed on a balance
accurately and precisely — while still meeting regulatory limits for variability.

It ensures that weighing errors are minimal and results are reliable, especially in analytical work and
GMP environments.
Ensures accuracy during weighing of small quantities in analytical and pharmaceutical labs.

Step-by-Step Procedure for Minimum Weight Determination

Step 1: Use a Suitable Standard or Sample

 Choose a small standard weight or a sample expected to be close to the minimum quantity
normally used.

Step 2: Weigh the Same Sample 10 Times

 Tare the balance.

 Place the same small weight (e.g., 10 mg or 20 mg) 10 times on the balance pan.

 Record all 10 readings.

Step 3: Calculate the Standard Deviation (SD) of the 10 values.

Step 4: Apply the Formula

USP <41> defines:

SD = Standard deviation of 10 weighings

0.01 = 0.1% (because USP <41> allows max RSD of 0.10%)

Step 5: Record the Calculated Minimum Weight

The value you calculate is the minimum weight that can be accurately measured on that balance
with an RSD ≤ 0.10%.

9. Documentation

 All results to be entered in the Balance Calibration Logbook.

 Maintain calibration certificates.

 Record environmental conditions.

10. Deviations

 Any deviation from this procedure must be documented and justified.

11. Annexures

 Annexure I: Calibration Data Sheet

 Annexure II: Environmental Monitoring Log

 Annexure III: Minimum Weight Calculation Template