Press Release Summary:
Tablex-PRO, powered by Safeline PowerPhasePRO software, detects particles smaller than 0.2 mm in dia, including stainless steel and irregular shaped contaminants such as slithers of metal and broken sieve wires. Dual level electronic signature log-in system captures and stores all access activities, providing full regulatory compliance with 21 CFR part 11. Inspection process traceability is supported through barcode and batch code information within the data collection and storage system.
Original Press Release:
Maximize Process Efficiency and Minimize Downtime
Mettler-Toledo Safeline has announced the release of a new generation of its well established Tablex metal detection system - the most sensitive metal detector in the World. Tablex-PRO uses a new version of advanced Safeline PowerPhasePRO software and is set to raise the standards adopted by the pharmaceutical industry.
Developed with today's highly regulated pharmaceutical production plants firmly in mind, and with an emphasis on current and future compliance requirements, Tablex-PRO delivers the opportunity for manufacturers to increase productivity, reduce overall manufacturing costs and improve their competitiveness. The new system will take metal detection for the pharmaceutical and nutraceutical industries to an even higher level of sophistication providing manufacturers with real benefits to address the challenges of an increasingly demanding market.
Major sensitivity enhancements have been achieved through the development of a new optimum power drive technique combined with the use of ultra high frequency operation. These new features will set new standards of performance within the industry, particularly with respect to the detection of stainless steel contaminants and irregular shaped contaminants such as slithers of metal and broken sieve wires. Tablex-PRO is capable of detecting particles smaller than 0.2mm in diameter.
Among the features in the new software package is a dual level, electronic signature log-in system which requires operators to enter a user name and password for access. This advanced system captures and stores all access activities in the form of an electronic access log. The log can be displayed and viewed on the full color touch screen along with other important manufacturing data providing full regulatory compliance with the requirements of 21 CFR part 11.
Inspection process traceability is supported through the inclusion of important barcode and manufacturing batch code information within the data collection and storage system. This key data can be displayed on the operator interface during the manufacturing process.
Enhanced quality assurance is provided through a dedicated password protected QA system access level. Tablex-PRO systems advise when test routines need to be performed and when testing is overdue via highly visible screen messages. Built-in performance validation software provides intuitive, step-by-step guidance for quality assurance testing.
Tablex-PRO is available with the METTLER TOLEDO EQPac qualification package to ensure manufacturers are able to provide the documentary evidence that processes and procedures meet predetermined specifications of FDA, GAMP and GMP requirements.
EQPac provides users with fully documented IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) and MQ (Maintenance Qualification) protocols, while a certified test kit enables pharmaceutical manufacturers to achieve regulatory compliance for their metal detectors.
Maximizing process efficiency and minimizing downtime are critical as manufacturers strive for operational excellence. The issue of maximizing uptime is addressed with a revolutionary Condition Monitoring feature which constantly assesses the performance and operation of key detector elements. This system gives advanced warning of changes which could potentially cause downtime if left unaddressed. Messages from the Condition Monitoring system are displayed on the high visibility touch screen user interface. The early warning of potential problems before they escalate to stop the production process enables maintenance routines to be conducted when equipment is off-line to maximize uptime and production capacity.
System faults and warning messages are also signaled via an optional high level, highly visible, tri-color status warning lamp. The lamp displays a green, amber or red status to indicate Condition Monitoring messages and give warnings of performance verification test requirements.
Critical messages from Tablex-PRO detectors can be communicated directly to key individuals within the manufacturers' organization via a unique GSM gateway communication system. This allows the detector so send instant SMS text messages and emails to those that need to know. Typically, maintenance engineers can receive early warnings regarding potential downtime or line stoppages via the Condition Monitoring feature, while QA or Production Managers can be advised of over-due validation testing of the system which could lead to non-compliance issues if not addressed.
Tablex-PRO retains the benefits offered on existing Tablex systems of a choice of two interchangeable and failsafe reject devices suitable for all product types and applications. The side diverter system is particularly effective where inlet and outlet heights are low or restricted - the compact design minimizes overall throughput length. The lift flap diverter system has been specifically developed for manufacturers needing straight line product flow. This can help to reduce potential damage to larger, effervescent and delicate tablets. Both systems offer simple 'no-tool' strip-down, easy cleaning and are fully compliant with CFR parts 210 and 211.