Liquid pharmaceutical manufacturers are challenged with ensuring that they produce precise dosage sizes, and that the origin of their drugs is completely traceable through the supply chain. Both are critical in ensuring patient safety, to combat counterfeit medicines, as well as contributing to their own operational efficiency and reputation. Mettler-Toledo Product Inspection’s new campaign – “Every Drop Counts” – reflects these market realities and is supported by two new solutions that will help manufacturers to meet them: the Mettler-Toledo StarWeigh™ Checkweigher, for precision weighing of liquid pharmaceuticals; and the Mettler-Toledo T60 Integrated 360 Series, bringing advanced Track & Trace capabilities to the market for round objects such as bottles and vials.
The market for liquid medicines is fast-growing, fuelled by the rising importance of biological products such as vaccines and oncological drugs. Pharmaceutical companies and packaging manufacturers are adapting to market demands for high production outputs, delivered quickly to market, and without compromising on the needs for quality control and regulatory compliance.
“Every Drop Counts” emphasises the importance of accurate product weighing and Track & Trace to help manufacturers ensure public safety and cost-effective production. It is imperative that liquid medication dosage sizes provided to the patient are authenticated at point of sale, as this has a direct impact on the safety and efficacy of their treatment. From a manufacturing point of view, delivering the exact dosage into bottles, vials and syringes, with no overfills or underfills, helps to meet compliance requirements and avoids expensive product giveaway. Track & Trace capabilities ensure that the origin of a manufacturer’s medicines can be proven against those of counterfeit medicines, while traceability down to an individual product level means pharma manufacturers can reduce the possibility of large and expensive recalls.
The StarWeigh™ Checkweigher
The Mettler-Toledo StarWeigh™ Checkweigher is designed to provide laboratory accuracy of fill levels at production throughputs for small, unstable or lightweight products, such as glass and plastic bottles, vials and ampules used in liquid pharmaceuticals. Up to four load cells can be fitted, including Mettler-Toledo’s next-generation FlashCell™, capable of delivering highly accurate weighing results (+/- 5mg) at speeds of up to 300 products per minute. StarWeigh™ is a compact checkweigher that can be installed within existing production lines and features customisable ‘starwheels’ to fit different package shape requirements and enable quick product changeovers.
The T60 Integrated 360 Series
To help liquid pharmaceutical manufacturers comply with regulatory demands, Mettler-Toledo has also launched the T60 Integrated 360 Series systems for Mark & Verify, Serialization and Aggregation of round objects such as bottles and vials. The T60 Integrated 360 Series offers the ability to control third-party systems that print codes directly onto bottles and vials versus the typical processes where bottles are inserted into cartons which are subsequently serialized. Manufacturers can save time and money by having fewer labelling and packaging processes. In addition, these technologies are backed-up by the company’s global network of service experts, providing remote and on-site support, as well as proven solution-based project management expertise in integrating OEM and proprietary technology into existing production lines.
The products can be immediately integrated into all applications where the production process needs to conform to pharmaceutical requirements such as 21 CFR part 11, with full traceability, audit trail and validation supporting documentation. This offers considerable time and money savings in all steps, from planning through to commissioning, and reduces time to market. In addition, features such as extended user management, audit trail and password protection support Good Manufacturing Processes, and limit the risk of not meeting compliance requirements.