Learn SOP for operating, cleaning, and calibrating friability test apparatus with step-by-step QC procedures and pharma compliance standards.

Definition

A friability test apparatus SOP is a standardized procedure describing how to operate, clean, and calibrate the instrument used to evaluate the mechanical strength of tablets by measuring weight loss after rotation under controlled conditions.

Parameter	Standard Requirement
Number of rotations	Typically 100
Drum speed	~25 rpm
Sample size	As per pharmacopeia
Acceptance limit	≤1% weight loss
Test type	Uncoated tablets

Step-by-Step List

Friability Test Procedure:

1. Weigh tablets before test
2. Place tablets in drum
3. Set rotations (e.g., 100)
4. Start the apparatus
5. Allow drum to rotate
6. Remove tablets after test
7. Reweigh tablets
8. Calculate % weight loss

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Introduction

Tablet durability is critical in pharmaceutical manufacturing, ensuring products withstand handling, packaging, and transportation without breaking. The friability test apparatus evaluates tablet resistance to abrasion and mechanical stress. https://www.webofpharma.com/2026/04/dissolution-apparatus-2-paddle-guide.html

A well-defined SOP ensures accurate, reproducible, and compliant results aligned with pharmacopeial standards such as USP and IP.

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1.0 OBJECTIVE

To establish a standardized procedure for operation and calibration of the friability test apparatus.

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2.0 SCOPE

Applicable to the Quality Control (QC) Department.

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3.0 RESPONSIBILITY

Supervisor Quality Control

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4.0 ACCOUNTABILITY

Sr. Manager Quality Assurance (QA)

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5.0 PROCEDURE

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5.1 Operation of Friability Test Apparatus

Step-by-Step Operating Instructions

1. Weigh the specified number of tablets accurately
2. Remove the acrylic cover of the drum
3. Place tablets inside the drum
4. Secure the cover using the plastic knob (avoid over-tightening)
5. Switch ON the main power supply
6. Display shows instrument startup message
7. Press ENTER to start program
8. Verify set rotations on display
9. Press START to begin test
10. Observe rotation count (Set vs Actual)
11. After completion, drum stops with beep sound
12. Remove tablets carefully
13. Reweigh tablets and calculate % weight loss

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5.2 Procedure to Set Rotations

1. Follow operation steps until program selection
2. Press INC switch
3. Display shows “SET ROTATIONS 0000”
4. Adjust digits using INC key
5. Press ENTER to confirm each digit
6. Repeat for all digits
7. Return to main screen for test execution

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5.3 Calibration Procedure

Calibration Steps

1. Clean instrument and drum thoroughly
2. Switch ON the instrument
3. Set 100 rotations
4. Observe actual revolutions manually
5. Record deviation in calibration log

Acceptance Criteria

• RPM should match standard within acceptable limits

Failure Handling

• Label instrument as “Out of Order”
• Inform service engineer or manufacturer

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5.4 Cleaning Procedure

Routine Cleaning Steps

• Switch OFF and unplug the instrument
• Remove drum and clean with soft cloth
• Avoid abrasive materials
• Ensure drum is dry before reuse
• Clean external surfaces regularly

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Calculation of Friability

Formula:$$\text{Friability (\%)} = \frac{W_1 – W_2}{W_1} \times 100$$Friability (%)=W1​W1​−W2​​×100

Where:

• W₁ = Initial weight
• W₂ = Final weight after test

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6.0 ABBREVIATIONS

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• Dept.: Department

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FAQs

1. What is friability testing?

It measures tablet resistance to mechanical stress. https://iampharmacist.com/bulk-density-apparatus/

2. What is acceptable friability limit?

Typically not more than 1% weight loss.

3. How many rotations are used?

Usually 100 rotations.

4. What type of tablets are tested?

Primarily uncoated tablets.

5. Why is friability important?

It ensures tablets remain intact during handling.

6. What happens if friability exceeds limit?

Batch may be rejected or investigated.

7. How is friability calculated?

Using weight difference before and after test.

8. What is RPM of friability apparatus?

Approximately 25 rpm.

9. Can coated tablets be tested?

Generally not required unless specified.

10. What standards apply?

USP, IP, and BP pharmacopeial guidelines.

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