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Designed to meet the exacting standards and regulations of the pharmaceutical industry, METTLER TOLEDO Safeline pharmaceutical metal detectors provide the ultimate solution in fully integrated product inspection and rejection systems for tablets, capsules, powders and granules. Our metal detection systems are designed to detect all metal contaminant types, including ferrous, non-ferrous and even the most difficult-to-detect non-magnetic stainless steels.
Meeting the requirements of FDA 21 CFR part 11 can be a challenge in some pharmaceutical processing environments. FDA metal detection limits support regulatory action against products with metal fragments 0.3 inch (7 mm) to 1 inch (25 mm) in length. Our Tablex-PRO pharmaceutical metal detector supports full compliance with standards and is designed to detect all possible metal contamination encountered in pharmaceutical manufacturing processes, including ferrous, non-ferrous and even the most difficult-to-detect non-magnetic stainless steels (grade 316). Contaminants less than 0.3mm in diameter can be readily detected and rejected.
Manufactured from mirror-polished stainless steel, and incorporating pharmaceutical-grade FDA-approved contact parts throughout, METTLER TOLEDO Safeline's range of Tablex and Pharma GF-PRO metal detection systems provide compact, easy-clean, hygienic inspection solutions to meet the metal detection needs of pharmaceutical manufacturers.
Pharmaceutical tablet metal detectors such as Safeline's Tablex 2 and Tablex-PRO, should be installed after tablet presses, de-dusters and other pharmaceutical process equipment, enabling manufacturers to comply with the needs of both internal standards and external regulatory requirements.
All METTLER TOLEDO Safeline pharmaceutical metal detectors support compliance with pharmaceutical regulatory standards and external codes of practice including:
METTLER TOLEDO Safeline's Tablex 2 and Tablex-PRO metal detectors are designed to inspect pharmaceutical tablets and capsules for any possible metal contamination encountered in pharmaceutical manufacturing processes. Systems are available in three standard aperture sizes to accommodate a wide variety of tablet and capsule sizes and throughput rates. There is also a choice of two interchangeable reject devices to suit all product types, applications and configurations.
Our Pharma GF-PRO metal detectors provide efficient inspection of powdered and granular pharmaceutical products under free-fall conditions, a process as important as inspecting tablets and capsules. Pharma GF metal detectors are compact in size, enabling installation to take place in highly restricted spaces. Apertures are available in a choice of two standard sizes to accommodate a wide variety of throughputs. A fully integrated high-speed reject device can also be incorporated to divert contaminated product flow. These can be rapidly dismantled and re-assembled (without the need for tools) for easy cleaning.
It is important that manufacturers understand how to verify the performance of their pharmaceutical metal detectors; if the system is not correctly tested at regular intervals, manufacturers run the risk of failing to comply with standards that could pose a serious threat to their business.
When implementing a metal detection test procedure, manufacturers must firstly ensure their metal detector meets the required detection standards and is set up within the sensitivity guidelines.
Guidance is given on non-ferrous and stainless steel ball sizes that can be detected, based upon actual ferrous ball size detected. Test tablets are the most common format for test samples used to test and verify pharmaceutical metal detector performance. Testing procedure checks include detector performance levels and complete system integrity/functionality.
In-built pharmaceutical industry specific performance validation software (PPVR) provides intuitive, systematic guidance for quality assurance testing. Test routines can be configured to ensure that system performance is validated and results are captured in order to meet internal procedures and external industry standards or regulations.
There are no mandatory guidelines on the frequency of tests, unless these have been identified by a retailer code of practice or by requirements from a customer or external agency. However, it is recommended that testing is carried out at the start and end of each shift and of each new product run, and should be clearly documented within standard operating procedures.
METTLER TOLEDO offers a wide range of products and services designed to support manufacturers in ensuring compliance with regulatory standards, and provides guidance on metal detector testing procedures
Validation is the initial qualification of a product or process against the stated design specification and belongs at the start of the pharmaceutical metal detector lifecycle when it is first installed into the production line. Re-validation may also be required if substantial modifications to the metal detector, or the products being inspected are made at any point after installation.
Validation procedures usually involve both internal and external parties. A well-executed and carefully carried out installation phase is the foundation of worry-free and efficient use of the metal detector. Therefore, equipment manufacturers are in a strong position to support their customers throughout the installation/start-up process by making sure that the equipment:
The verification procedure ensures that pharmaceutical metal detector remains complaint against sensitivity standards and metal detection policies. The metal detector is periodically verified (typically at 6 to 12 month intervals) to ensure compliance and demonstrate due diligence. In addition, verification ensures that the metal detector:
METTLER TOLEDO offers a wide range of products and services designed to support manufacturers in ensuring compliance with regulatory standards, and provides guidance on the validation, verification and monitoring for product inspection equipment.