SOP for Capsule Counting Machine Setup, Operation, and Shutdown

A capsule counter SOP document is a GMP requirement that controls how capsule counting must be performed in a pharmaceutical facility. Without a standard operating procedure, counting becomes subjective, inconsistent, and risky.

Below, we’ll share the capsule counter SOPs commonly used in the pharmaceutical industry. You can use these as references to create your own customized SOP tailored to your facility’s processes, or you can download our ready-to-use document.

1.0 Purpose

The purpose of this tablet/capsule counter SOP is to define the step-by-step procedure for preparing, operating, verifying, documenting, and cleaning the capsule counting machine. This procedure ensures that each bottle, pouch, or container receives the correct number of capsules as per the Batch Manufacturing Record (BMR).

This SOP also aims to prevent counting errors, mix-ups, cross-contamination, and deviations during capsule counting operations.

2.0 Scope

This SOP applies to:

2.0.1: All operators assigned to capsule counting activities in the production or packaging area.

2.0.2: Production supervisors overseeing capsule counting operations.

2.0.3: Quality Assurance (QA) personnel who are responsible for reviewing and approving documents.

2.0.4: Any capsule counting machines, semi-automatic or automatic, used for oral solid dosage forms.

3.0 Responsibility

3.0.1: It includes the employees responsible for making sure the SOPs are being followed.

3.1 Operator

3.1.1: Prepare the machine and materials before startup.

3.1.2: Operate the capsule or tablet counting machine as per this SOP.

3.1.3: Ensure correct settings for capsule size, quantity, speed, and batch details.

3.1.4: Perform in-process checks, machine adjustments, and stoppage when required.

3.1.5: Record all data in real-time in the BMR and relevant logs.

3.1.6: Immediately report any discrepancy or abnormality to the Production Supervisor.

3.2 Production Supervisor

3.2.1: Verify correct machine setup prior to operation.

3.2.2: Ensure that counting is performed according to the approved BMR.

3.2.3: Confirm line clearance before and after the operation.

3.2.4: Investigate any discrepancies or abnormalities reported by the operator.

3.2.5: Ensure operators follow GMP, safety, and documentation standards.

3.3 Quality Assurance (QA)

3.3.1: Review completed BMR entries, in-process checks, and logs.

3.3.2: Verify compliance with SOP, GMP, and regulatory requirements.

3.3.3: Approve equipment before release for the next batch after cleaning and documentation review.

4.0 Equipment and Materials Required

Operators must ensure that all required materials listed below are available before starting the activity.

4.0.1: Tablet/Capsule counting machine with all parts assembled for the correct capsule size.

4.0.2: Empty bottles, pouches, or containers as specified in the BMR.

4.0.3: Batch Manufacturing Record (BMR).

4.0.4: Barcode or printed labels (if applicable).

4.0.5: Cleaning tools: brushes, approved cleaning agents, and lint-free wipes.

4.0.6: Gloves and protective clothing.

4.0.7: Calibration weights (if weight-based verification is used).

5.0 Procedure

Here’s the procedure that everyone needs to follow:

5.1 SOP Purpose Verification

5.1.1: Read and understand the BMR and this SOP before beginning.

5.1.2: Confirm the product name, strength, capsule size, batch number, and filling quantity.

5.2 Pre-Operation Setup

5.2.1: Ensure the machine is clean and marked “Cleaned” on the equipment status label.

5.2.2: Turn ‘ON’ the capsule counter.

5.2.3: Select:

5.2.3.1: Correct capsule size

5.2.3.2: Required quantity per bottle

5.2.3.3: Production speed or vibration level

5.2.3.4: Batch details (if machine requires input)

5.2.4: Run a short test with a small number of tablets or capsules.

5.2.5: Check smooth movement through the hopper and chute.

5.2.6: Verify that photoelectric or mechanical sensors read correctly.

5.2.7: Adjust vibration or flow angle if capsules jam or bridge.

5.2.8: Call the Production Supervisor for pre-run approval.

5.3 Capsule Counting Operation

5.3.1: Gently pour tablets or capsules into the hopper. Avoid overfilling.

5.3.2: Ensure a continuous and steady flow.

5.3.3: Start the counting operation as per the approved settings.

5.3.4: Observe:

5.3.4.1: Flow of capsules

5.3.4.2: Sensor performance

5.3.4.3: Bottle alignment

5.3.4.4: Consistency of count

5.3.5: Stop the machine immediately if:

5.3.5.1: Jamming occurs

5.3.5.2: Capsules or tablets bounce or double-count

5.3.5.3: Misalignment is seen

5.3.6: Correct the issue before resuming.

5.3.7: Continue operation until the full batch is completed.

5.4 In-Process Verification

5.4.1: Perform counter verification at regular intervals (as per BMR)

5.4.2: Select filled containers randomly.

5.4.3: Verify counts by either:

5.4.3.1: Manual recounting

5.4.3.2: Weight check using the average capsule weight

5.4.4: If a mismatch is found:

5.4.4.1: Stop the machine

5.4.4.2: Isolate affected containers

5.4.4.3: Recount and correct the issue

5.4.5: Record results immediately in the BMR.

5.4.6: Do not ignore even a small variation.

5.5 Documentation Requirements

5.5.1: Record all machine parameters, checks, corrections, and counts in:

5.5.1.1: BMR

5.5.1.2: Equipment logbook

5.5.1.3: In-process control sheet

5.5.2: Documentation must be done at the time of the activity, not later.

5.5.3: Record:

5.5.3.1: Machine settings

5.5.3.2: Total capsules counted

5.5.3.3: Rejects

5.5.3.4: Any adjustments made

5.5.3.5: Operator initials with date and time

5.5.4: “If it is not written, it is considered not done.”

5.6 Post-Operation Cleaning and Shutdown

5.6.1: Switch OFF the machine.

5.6.2: Remove all remaining capsules from the hopper, chute, and trays.

5.6.3: Disassemble contact parts carefully.

5.6.4: Clean each part using approved cleaning materials.

5.6.5: Remove all powder, residue, and dust.

5.6.6: Wipe machine surfaces with a lint-free cloth.

5.6.7: Clean the surrounding area to remove any fallen capsules or residue.

5.6.8: Perform line clearance and document it.

5.6.9: Sign the equipment cleaning log, including:

5.6.9.1: Batch number

5.6.9.2: Product name

5.6.9.3: Cleaning date and time

5.6.9.4: Operator initials

5.6.10: Supervisor and QA must verify cleaning before releasing the machine.

6.0 Acceptance Criteria

6.0.1: All containers must contain the exact number of capsules as per BMR.

6.0.2: No cross-contamination or mix-ups.

6.0.3: Complete, accurate, real-time documentation.

6.0.4: Clean machine with no residue before release.

7.0 Definitions

7.0.1: BMR: Batch Manufacturing Record containing batch-specific instructions.

7.0.2: Capsule Counter: A machine used to count and dispense capsules into containers.

7.0.3: Line Clearance: Process of ensuring no materials from the previous batch remain in the area.

7.0.4: In-Process Check: Verification during operation to ensure accuracy and compliance.

Download the Capsule Counter SOP PDF for Free

Download Capsule Counter SOP PDF

The Capsule Counter SOP PDF we’ve prepared is a ready-to-use form designed for operators on the production floor. That means operators can quickly verify that every step is executed exactly in accordance with GMP standards.

The Right SOP Works with the Right Machine

A capsule counter SOP gives structure, reduces mistakes, and guarantees that every unit leaving your facility is compliant. However, it’s extremely important that the machine you have works accurately and provides consistent performance.

This is only possible when you choose the right partner, such as Finetech. We have been delivering high-quality equipment to the pharmaceutical industry for over 30 years.

Our capsule counting machines are designed specifically for counting accuracy, smooth capsule flow, and fast changeovers between batches. With Finetech, you get equipment that keeps your counting process simple and accurate every time.

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