Manufacturers have an obligation to consumers to ensure their products are safe, particularly in the pharmaceutical industry. No manufacturer wishes to deal with the problem of a product recall caused by the discovery of, say, fragments of broken sieve wire in the medicine. The fallout doesn’t just impact profit margins in the short term, it can damage the trust consumers have in the product, hitting sales and market share in the long term. It is vital, then, that manufacturers do all they can to ensure the welfare of their customers by not only ensuring the product contains what it stipulates on the side of the box, but also by identifying any instances of physical contamination from metal shards.
Quality control is vital on pharmaceutical production lines to safeguard against contamination, and there are a number of strict safety standards companies can use to set the framework for manufacturing processes. These include the US Food and Drug Administration’s (FDA) Process Analytical Technology (PAT) guidance – a mechanism to design, analyse and control pharmaceutical manufacture – and Good Manufacturing Practice (GMP) – aimed primarily at diminishing the risks inherent in pharmaceutical production, including contamination from metal bodies.
To comply with these best practice guidelines, pharmaceutical manufacturers require reliable advanced product inspection technology, such as metal detectors specially developed for pharmaceutical lines. Equipment such as Mettler-Toledo Safeline Metal Detection’s Tablex integrated metal detector and high-speed rejection system for inline tablet and capsule inspection, and the Pharmaceutical Gravity Fall Pharma GF-PRO system for free-falling powdered and granular materials, have been designed specifically to uphold the exacting standards expected of the pharmaceutical industry.
When searching for metal detection machinery for their lines, there are a number of design features that pharmaceutical companies should look out for to ensure it meets safety requirements. Such things can mean the difference between a product inspection system that meets minimum standards and one that offers ‘best practice’. Mettler-Toledo Safeline Metal Detection has compiled a list of things for pharmaceutical manufacturers to take into account to ensure their product inspection processes and their products truly are ‘best in show’.
Best practice 1: Making records
In compliance with Section 2.1 f of the proposed updates to World Health Organisation (WHO) GMP for Pharmaceutical Products: Main Principles from January 2013, records have to be made, either manually or using automated technology, during the manufacturing process to provide proof of compliance. On top of this, it is also vital that manufacturers keep comprehensive data on batch history and distribution in a readily accessible form to optimise traceability and, in the event of a product recall, to enable to source of any quality issue to be correctly located.
Metal detection systems that have been designed and built to comply with FDA and GMP standards are ideal here to satisfy pharmaceutical industry demands for data monitoring and traceability. Those developed specifically for pharmaceutical applications can arrive on the production line ready for connection to the manufacturers’ data collection devices, ensuring full compliance with industry regulations.
Mettler-Toledo Safeline Metal Detection’s Tablex-PRO pharmaceutical metal detectors, for example, feature a data storage function that is easy for machine operatives to set up, thanks to its colour touch screen and Windows-style icon driven Human Machine Interface (HMI). All of this makes it simple for operatives to navigate the machine’s set up options with minimal training, reducing unnecessary downtime. On-screen histograms – graphical representations of the distribution of product inspection data – are able to provide an easy-to-understand visual breakdown of performance and historical inspection records. What’s more, for multinational manufacturers, flexible connectivity interfaces simplify integration with external data collection systems, enabling the monitoring of the company’s entire production process.
Best practice 2: Cleaning up
One of the parameters to meet GMP requirements is to uphold the highest hygiene standards on pharmaceutical production lines. To facilitate this, production line machinery designs must, where possible, ledges, corners and flat surfaces that can act as dirt traps where excess layers of dust can accumulate. They must also be easy to clean, with modules that can be dismantled efficiently with the need for tools, and made of materials. However, at the same time, they must also be made of robust materials, such as stainless steel, capable of withstanding harsh and repeated wash-downs without succumbing to corrosion.
Metal detectors that are compact, with rounded corners and curved surfaces can streamline the cleaning process for pharmaceutical manufacturers, enabling them to comply with PAT and GMP standards. Technologies, such as the Tablex-PRO, can be easily dismantled and reassembled without the need for tools or small parts, making it simple to perform regular hygiene inspections of every aspect of the machine. With the electrical components removed, the fully water proof modules, built in mirror-finish stainless steel, can be fully submersed in water, ensuring optimal cleaning and best practice.
Best practice 3: Operator training
However, to ensure Best Practice, it is not enough simply to integrate data monitoring technologies, or easy-clean machines. It is also imperative that machine operatives on pharmaceutical production lines be properly trained to ensure such comprehensive data monitoring and cleaning are taking place and to guarantee that these procedures are documented correctly.
By selecting pharmaceutical metal detectors that feature advanced HMIs with icon-driven displays, manufacturers can ensure that their product inspection system’s data collection process is easy to navigate with minimal training. This not only saves time during product changeovers, boosting productivity, but also lowers the risk of human error affecting data monitoring.
In addition, advanced metal detectors that feature built-in performance validation software can indicate to operatives when scheduled testing is due and guide them through step-by-step test routines. This ensures that product inspection performance monitoring takes place as often as is required by GMP Best Practice guidelines and to the standard expected.
Better than best
Compliance with pharmaceutical manufacturing guidelines regarding product inspection machinery can be a complicated process, but it is vital that manufacturers do so, not only to retain access to lucrative international markets, but also to uphold the safety of the consumers using their products. However, by adhering to the three best practice guidelines in this article, pharmaceutical manufacturers can ensure that they select metal detection systems that not only meet GMP and PAT standards, but surpass them, achieving best practice on their lines and optimising consumer wellbeing.
Mettler-Toledo Safeline is the world’s leading supplier of metal detection and x-ray inspection solutions for the food and pharmaceutical industries. Together with Garvens Checkweighing, CI-Vision and Pharmacontrol Electronic GmbH (PCE), Mettler-Toledo Safeline forms the Product Inspection division of Mettler-Toledo.
For more information on irregular shaped contaminants or any aspect of metal detection procedures and technology, call Sanjeev Kumar Kapoor, Head of Marketing, Mettler-Toledo India Private Limited on +91 9769086311 or email Sanjeev.kumar@mt.com.
For general information on
Mettler-Toledo Safeline, visit:http://www.mt.com/pi, http://www.mt.com/safeline- metaldetection u
(The author is Head of Marketing, Mettler-Toledo Safeline Metal Detection)