A product format change can seem straightforward. A new tablet size, capsule shape, coating, or formulation may still appear compatible with the same packaging line, but even small physical differences can affect feeding, separation, counting accuracy, and bottle filling. For this reason, validation should not end with confirming that the new product runs through the machine.
A structured revalidation helps confirm that a tablet counting machine continues to deliver consistent performance under the new operating conditions. Pharmapack designs automatic counting systems for tablets, capsules, caplets, soft gels, and other solid products, with features such as product count verification, dust compensation, fault diagnosis, and quick changeover.
Why a Format Change Requires Revalidation
Counting equipment depends on the physical characteristics of the product. Diameter, length, thickness, weight, surface properties, shape, and tendency to generate dust can all influence how products move through the feeding and counting system.
A format change may therefore alter how products pass through vibratory plates or counting channels. If tablets begin to overlap, rotate differently, move irregularly, or pass sensors at different intervals, the original machine settings may no longer provide the same counting performance.
This is particularly important when one machine is used for multiple products. Pharmapack's modular counting systems are designed to accommodate different tablet and capsule formats, but the applicable product range and operating parameters still need to be considered for each application. For example, the LFM series can handle products including tablets, capsules, caplets, and soft gels within specified size ranges.
Confirm the New Product Specification First
Before testing the machine, document the differences between the previous and new formats. The key information should include product dimensions, shape, weight, surface characteristics, hardness, coating, and packaging quantity.
Container specifications should also be reviewed. A change in bottle diameter, height, opening size, or filling quantity can influence the relationship between counting and filling operations.
The objective is to establish whether the new format remains within the machine's validated operating range. This should be supported by product trials rather than relying only on nominal specifications.
Check Feeding and Product Separation
The first operational check should focus on product feeding. A tablet counting machine needs to move products into the counting area in a controlled and sufficiently separated flow.
Observe whether the new format travels smoothly through the feeding system and whether products remain properly separated. Pay attention to overlapping tablets, unstable movement, excessive vibration, product accumulation, and inconsistent flow.
Pharmapack's modular counters use multi grade vibratory plates to guide products into channels and create single file movement. Correct vibration settings are therefore an important part of achieving stable counting performance after a format change.
Verify Counting Accuracy at Different Conditions
Counting accuracy should be checked using representative production conditions rather than a single short trial. Test the intended filling quantities and evaluate whether the machine consistently delivers the programmed count.
It is also useful to assess performance at different operating speeds. A product may count accurately at a lower speed but behave differently when the machine approaches its intended production rate.
Modern pill counting machines can incorporate sensors, product verification, rejection mechanisms, and real time monitoring to identify counting problems. Pharmapack's PP Counter series includes product count verification and removal functions, while its electronic counting systems use sensors and monitoring functions to support accurate operation.
Review Rejection and Detection Functions
Validation should cover more than successful bottles. The rejection system should also be challenged to confirm that abnormal conditions are identified and handled correctly.
Depending on the equipment configuration, this may include undercounted or overcounted bottles, defective products, or other detected abnormalities. The purpose is to verify that the machine responds according to the established operating procedure and that rejected products do not unintentionally return to the production flow.
For applications requiring additional inspection, Pharmapack also offers counting systems incorporating inspection and rejection functions. Its 360 counting and sorting equipment combines counting, detection, and online rejection within the production process.
Check Cleaning, Changeover, and Settings
A format change is also an opportunity to review changeover procedures. Product contact parts should be accessible for cleaning, and operators should be able to identify which parameters require adjustment for the new product.
Important settings may include vibration frequency, counting sensitivity, product flow, speed, and bottle filling parameters. The exact settings depend on the product and machine configuration, so they should be established through documented trials rather than copied automatically from another format.
Pharmapack's modular counter designs emphasize tool less changeover, accessible product contact areas, and reduced change parts to simplify format transitions.
Document the Revalidation Results
After testing, record the product specification, machine configuration, operating parameters, test quantities, production speed, counting results, rejection results, and any adjustments made during the trial.
The final documentation should clearly show whether the new format meets the established acceptance criteria. If the product requires new settings or components, those changes should also be reflected in the operating procedure and maintenance documentation.
A tablet counting machine should not simply be judged by whether it can run a new product. The more important question is whether it can run that product consistently, accurately, and within the defined operating conditions.
Building Reliable Counting Performance After Format Changes
Product changes are a normal part of pharmaceutical and healthcare packaging operations, but they should be supported by controlled validation. Reviewing product specifications, feeding behavior, counting accuracy, rejection performance, cleaning, changeover, and documentation provides a practical framework for confirming machine performance.
At Pharmapack, our automatic counting systems are developed for applications involving tablets, pills, capsules, and other solid products, with configurations available for different product and packaging requirements. A structured format change assessment can help determine the appropriate machine configuration and operating parameters before production resumes at full scale.