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 StarWeigh checkweigher, for precision weighing of liquid pharmaceuticals; and the 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 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 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.
To help liquid pharmaceutical manufacturers comply with regulatory demands, Mettler-Toledo has also launched the T60 Integrated 360 series systems for mark & verify, serialisation and aggregation of round objects such as bottles and vials. It 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.
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.
“Every Drop Counts is a message that every liquid pharmaceutical manufacturer will understand implicitly as it carries with it both a consumer safety and a financial performance imperative. You could argue that it should guide every decision they make around their production operation,” said Wulf Pries, Market Manager, Mettler-Toledo Product Inspection. “Correct fill levels are not just a matter of profitability – they are critical to patient safety in many instances. Likewise, the ability to track and trace individual products in the pharmaceutical industry is a critical tool to fight the scourge of counterfeit medicines, which has come to represent a major potential threat to patient safety.”
“There is no better way to approach this issue than with advanced product inspection solutions, with precision checkweighing and advanced in-line track and trace leading the way. Glass vials in particular require highly precise weighing applications as tare weights can differ dramatically. Both the StarWeigh and the FlashCell technology deliver the high precision that is required. Coupled with sophisticated solutions for traceability, these systems provide transparency in distribution as well as trust for the consumer that the product they are buying is not counterfeit.”
