| Calibration and control program | Confirm the machine can be covered by written procedures for calibration, inspection, or checks, as applicable to its intended use. | Review the proposed procedure, assigned responsibilities, check frequency, acceptance criteria, and record-retention process. | FDA 21 CFR 211.68(b) requires applicable automatic, mechanical, and electronic equipment to be routinely calibrated, inspected, or checked under a written program, with records maintained. The regulation does not specify one universal frequency or tolerance. |
| Count accuracy | Assess performance with the actual product types and count sizes expected in production. | Run repeated trials using a known, independently verified quantity. Record the target count, observed count, product, run conditions, and any discrepancies. | Establish acceptance limits through your quality system and process validation; do not assume a single accuracy claim applies to every tablet, capsule, or operating condition. |
| Product and format range | Check compatibility with the shapes, sizes, coatings, and physical characteristics of the products to be counted. | Test representative products, including formats likely to challenge feeding or separation, and document results. | Request product-specific performance information and verify it in your own operating conditions before purchase or routine use. |
| Operating range and throughput | Determine whether the stated count range and operating speed fit batch sizes and line requirements. | Conduct trials at planned operating settings and at relevant low and high count quantities; observe jams, missed counts, and interruptions. | Compare demonstrated performance, not just nominal maximum speed. Confirm that the selected range supports the intended production process. |
| Setup and changeover controls | Review how product settings, count targets, and other operating parameters are selected and protected from unintended changes. | Check access controls, recipe or setting identification, change records, and independent verification requirements where applicable. | Choose controls that support approved procedures and reduce the risk of using an incorrect setup after product changeover. |
| Challenge checks and fault detection | Determine whether the machine can be checked using defined test quantities and whether relevant faults or count deviations are detected. | Evaluate documented challenge tests and, where provided, alarm or reject behavior using controlled test conditions. | Define which checks are appropriate for the equipment and process. Record results and investigate failures according to written procedures. |
| Records and traceability | Confirm that calibration, inspection, and check results can be documented and linked to the equipment and date of activity. | Review sample records for equipment identification, test standards or references used, results, acceptance decision, performer, and review where required by procedure. | Ensure records are maintained in accordance with applicable cGMP requirements and the site’s document-control practices. |
| Maintenance and service support | Assess access to maintenance, parts, service documentation, and technical support for the intended operating environment. | Review maintenance instructions, recommended service activities, training needs, and the process for documenting work that may affect performance. | Plan for post-maintenance checks when work could affect counting performance or equipment controls, as defined in site procedures. |
| Final qualification decision | Confirm that the selected machine is suitable for its intended use and that required procedures and training are in place. | Document the risk-based evaluation, test results, approved operating range, calibration or check plan, and any limitations. | Make the final decision through the appropriate quality and engineering review. Equipment suitability depends on documented performance for the intended process. |