Tablex-PRO Pharmaceutical Metal Detectors - 概要 - メトラー・トレド

Tablex-PRO Pharmaceutical Metal Detectors

Designed and built to comply with and exceed FDA and GMP standards and to satisfy the demands of the pharmaceutical industry regulation, Tablex-PRO metal detection systems provide the ultimate in mobile, fully integrated product inspection and rejection systems for tablets and capsules.

Tablex-PRO pharmaceutical inspection systems utilise high frequency operation to provide the highest attainable metal detection sensitivity to all metal contaminants. Difficult to detect non-magnetic stainless steels and irregular shaped contaminants such as minute pieces of sieve wire and swarf are readily detected and rejected with ease.

Exceptional performance in pharmaceutical process environments is enhanced through robust construction techniques enabling previously unseen levels of on-line stability to be attained.

The compliance needs of 21 CFR part 11 are fully met through the provision of dual-level, high security log-in facilities for operators and the capture of electronic signatures and other process data.

A choice of advanced failsafe reject devices including side diverter and lift flap options are available ensuring any contaminated product is rapidly removed from the product flow.

Tablex-PRO detectors utilise Profile software technology which incorporates continuous Condition Monitoring functionality to assess key component performance and to give advanced warning of adverse trends which could lead to equipment failure if left unaddressed. Early warnings can be communicated via SMS text messages or email to key operational personnel.

Features and Benefits

Unrivalled sensitivity and stabilityThe maximum capacity to detect all metal contaminants combined with robust, on-line stability to minimise instances of false reject events
Full 21 CFR part 11 complianceHigh security, dual level operator log-in facility with full electronic signature capture ensures full regulatory compliance to be met
Failsafe reject systemsA choice of genuine failsafe reject systems is available including side diverter and lift flap options
Hygienic, easy clean designNo tools required for dismantling/assembly. Fully submersible contact parts for easy cleaning
Performance validation softwareBuilt-in performance validation software indicates when scheduled testing is due and assists QA staff by guiding them through step by step test routines
Easy to useThe intuitive Profile full colour touch screen operator panel provides easy set up requiring minimal operator training and reduced downtime between product changes
Pharmaceutical construction standardsDesigned and built in mirror finish stainless steel to comply with 21 CFR parts 210 & 211
Built-in condition monitoringConstant analysis of the detection coil and electronics systems provide advanced warning of potential problems prior to failure enabling planned maintenance routines to take place
SMS and email communications facilitiesCommunication of key production process messages for maintenance and QA procedures maximises uptime and manufacturing efficiency
Connectivity optionsCan be provided with an integral Ethernet adapter enabling connection to all external data collection devices and factory management systems

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Tablex-PRO Pharmaceutical Metal Detectors

Effective Relief from Contaminant Headaches

Discover why manufacturers like Rottendorf Pharma choose METTLER TOLEDO metal detection systems to address the challenges of an increasingly demanding, regulation-driven market.

Tablex-PRO and Pharma GF-PRO from METTLER TOLEDO Safeline utilize advanced Profile software to raise metal detection sensitivity standards in the pharmaceutical industry. Rottendorf Pharma GmbH, an international pharmaceutical manufacturer that specializes in contract manufacturing, relies on METTLER TOLEDO metal detection systems to maximize product quality, enhance manufacturing efficiency and protect its brand and reputation.

Enabling Factories of the Future Through Emulation
Advances in manufacturing technologies such as cloud computing, increased automation and data exchange are allowing organizations to gain greater visibility of their industrial processes. With Industry 4.0 firmly making its mark within the manufacturing industry, the availability of smaller and more powerful sensors, in combination with high-speed network connectivity, has made it increasingly possible to gather, transmit and interpret data in real-time. This has led to the creation of smarter factories with improved productivity.

One of our recent innovations includes an introduction of a new set of features to our Tablex-Pro metal detectors, including the ability to mirror the metal detector's interface remotely, known as Emulation.

Using a Virtual Network Computing (VNC) client, Emulation allows operators to mirror the interface of one or multiple in-line metal detectors onto networked devices, including mobile phones, tablets and laptops and other industrial equipment. This approach is an extremely flexible method of data display, delivering productivity benefits through improved access to data remotely, as well as delivering safety benefits by reducing the need for line operators to access the metal detector directly, which are often installed in hazardous or inaccessible locations.

Regulatory Compliance

Tablex-PRO and Pharma GF-PRO support regulatory compliance by meeting the needs of 21 CFR part 11 and Good Automated Manufacturing Practice (GAMP).

Achieving regulatory compliance is essential for Rottendorf who produce up to 90 different products in a week for a variety of clients. Scheduled performance verification tests are conducted before and after each new batch of products. Authorized employees log on with their individual user name and password to perform the verification tests, apply new settings or prepare a batch change. This provides full audit traceability, supporting regulatory requirements.

"At peak times we can make up to 400,000 tablets per hour. The Tablex-PRO not only improves the quality of our products, it also reduces production costs thanks to its accurate rejection process and quick setup," explains Michael Barton, Head of Tablets and Coating at Rottendorf.

Qualification

System Qualification is supported through a METTLER TOLEDO EQ-Pac qualification package which ensures manufacturers have documentary evidence that IQ, OQ and PQ validation protocols have been satisfied. A certified test kit provided as part of the EQ-Pac package supports ongoing regulatory compliance for metal detectors.

Highest Detection Sensitivity

Optimum sensitivity and stability mean Tablex-PRO metal detection systems can detect and remove every metal contaminant from manufacturing processes. This includes the most challenging non-magnetic stainless steels and irregularly shaped contaminants such as swarf and broken sieve wires.

Curing Inefficiency

Tablex-PRO and Pharma GF-PRO detection systems feature an intuitive full-color touchscreen and can be set up quickly to maximize production uptime. As a self-contained system, the Tablex-PRO is fully mobile and can be rapidly dismantled, cleaned and assembled to meet the most demanding hygiene standards.

The Condition Monitoring feature provides advanced warning of changes which could potentially cause downtime if left unaddressed. Maintenance routines can be conducted when equipment is off-line to maximize uptime and production capacity.

METTLER TOLEDO Safeline metal detection systems provide the ultimate in flexibility and offer a high degree of customization for easy integration into any pharmaceutical manufacturing process regardless of the application.

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