Counting technology provider Kirby Lester, LLC’s announced that its KL1 tablet counter reduced quality control (QC) time by 50% and increased counting accuracy for an international contract pharmaceutical packager. The KL1 was the subject of a thorough validation study performed by Sharp Packaging Solutions.
Sharp also realized a positive return on investment (ROI) in only 10 months. Based on the successful completion of its validation study, Sharp now uses KL1 tablet counters for hourly QC checks on all bottling lines and for small-quantity bottle filling.
Sharp fulfills greater than 100 pharmaceutical bottling projects per month on fully automated bottling lines. A major compliance requirement for a bottling line is to assure accurate product counts. Manual counting and QC methods with hand-counting trays and scales are commonly used in pharmaceutical packaging processes, but these manual processes can negatively affect accuracy, customer satisfaction, and FDA/GMP compliance. The KL1 decreased QA inspection time during commercial bottling and increase filling accuracy.
“After we completed validation testing, we found the KL1 met every expectation,” says Ron Bates, Sharp’s Senior Project Engineer for New Business Development. “The KL1 devices decrease counting time and improve accuracy. If you are in the business of verifying in-process counts of bottles, the KL1 should get a serious examination.”
Sharp Packaging Solutions' validation study findings included:
• Accuracy: Three different oval tablets were selected for validation activities. Each size was tested for the following counts: 1, 10, 25, 40, 75, 195, 260, and 300, with no count errors. A repeatability test was conducted using 300 tablets; no counting errors were documented over 10 repeatability trials.
• Labor savings: Sharp Quality’s validation study included financial impact; ROI is expected to be reached within 10 months per device in labor savings alone (not including product loss that was known to occur with manual methods and ensuing customer financial penalties).
• Superior to the counting tray and scale, in terms of accuracy and time.
• Removable contact parts: The top funnel, inside channel, and bottom tray can be removed from the KL1, and Sharp maintains an inventory of dedicated “contact part kits” for every product they package.
• Versatility: The KL1 can be used for a wide variety of processes, including smaller count runs, return counts, reconciliation counts, and waste counts. The KL1 is also portable and is used by multiple Sharp departments.