The safety of modern pressed pill machines is guaranteed by diverse design requirements. For example, the EU Machinery Directive ISO 13849-1 requires that the safety interlock device failure rate of the sheet press should be less than 10^-6/ hour, and the response time of the emergency brake is less than 0.5 seconds, which has the effect of reducing the risk of equipment accidental start by 99.7%. In 2022, the FDA’s random check of 1,200 tablet presses worldwide found that the failure rate of GMP compliant models (e.g., Fette PT 4090) was only 0.03%, while that of non-compliant models was up to 1.2%, mainly due to pressure sensor deviation of more than ±5% or lubrication system leak.
Protection system forms the core of security. The IP54 protection class of German Korsch XL 100 tablet press can be applied in the humidity ≤90% environment and dust concentration ≤5 mg/m³ environment and is equipped with a pressure overload protection device that automatically cuts off when the load exceeds 120 kN for the purpose of avoiding mold burst. In 2021, Bayer Group achieved a reduction of 42 percent in occupational injuries and 18 percent in maintenance costs through the development of press safety modules, i.e., the grating barrier for Schubert CVC 4.0. In India, a generic drug manufacturer used a pressed pill machine with no infrared human detection, resulting in operator hand squeezing accidents and direct losses of $2.3 million.
Material and process risks need to be strictly controlled. The press punch of the Swiss GEA Courtoy ModuL P series is tungsten steel coated with a hardness of HRA 92, which prolongs the lifespan of 5 million presses and a wear rate of less than 0.01 mm/ 100,000 pieces. An investigation in “Pharmaceutical Engineering” in 2023 showed that if low-quality alloys (e.g., hardness < HRA 85) are used, punch breakage is 6 times more likely and the risk of tablet contamination by debris is 0.15%. Additionally, the United States Catalent company through real-time monitoring system, the internal temperature fluctuation of the tablet press is ±1.5°C, such that the activity retention rate of the heat-sensitive raw material (e.g., probiotics) is ≥95%, which is better than 82% of regular equipment.
Regulatory authentication and maintenance policies affect the security cycle. FDA 21 CFR Part 11-compliant tablet presses such as the Manesty Xpress 700 need to calibrate pressure accuracy (error ≤±1%) every 6 months and require an annual maintenance budget of approximately $12,000 – $50,000. In 2020, Pfizer did not timely replace the wear mold (thickness < 8.5mm) of the pressed pill machine, resulting in the tablet weight deviation being more than 7% and the recall loss being more than 80 million US dollars. But Roche Pharmaceuticals has a predictive maintenance system that can sense bearing failure 15 days in advance through vibration analysis, with downtime reduced by 75% and productivity improved by 12%.
Emerging technologies continue to stretch security boundaries. Sanofi introduced the AI-powered pressed pill machine (e.g., Glatt GPCG 3.0) in 2022, which detects foreign bodies in real time through image recognition with an accuracy of 99.4% and a false positive rate of only 0.3%. Digital twin system, developed by Novartis in collaboration with Siemens, simulates the sheet press stress distribution under extreme pressure (150 kN), increasing the accuracy of structural fatigue failure risk prediction up to 98% and adding 20% to equipment life. By the year 2025, the investment in the safety of worldwide intelligent tablet machines will reach 4.7 billion US dollars, with a compound growth rate of 9.8% per annum, further reducing the combined risk of human operation and mechanical failure.