Few industries are as heavily regulated as the pharmaceutical industry. Manufacturers must do all they can to protect customers by ensuring products contain what they stipulate on the label and that they're free-from metal contaminants. The repercussions of a product recall due to fragments of broken sieve wire found in medicine can be catastrophic. As well as impacting profit margins in the short term, a recall can damage consumers' trust in the product, hitting sales and market share in the long term.

Quality control is vital on pharmaceutical production lines to safeguard against contamination. Companies can use a number of strict safety standards 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) – which is aimed primarily at reducing the risks inherent in pharmaceutical production, including metal contamination.

To comply with these best practice guidelines, pharmaceutical manufacturers require reliable 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 and built to address the challenges of an increasingly demanding and regulation-driven market.

When searching for metal detection machinery for their lines, pharmaceutical companies should look out for a number of design features to ensure equipment meets safety requirements. These features can mean the difference between a product inspection system that offers 'best practice' and one that simply meets minimum standards. Below is a list of features pharmaceutical manufacturers should consider to guarantee their product inspection processes and products are ‘best in show’.

Best Practice 1: Generating records
In compliance with Section 2.1 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. Manufacturers must also 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 the source of any quality issue to be identified.

Metal detectors that have been designed and built to comply with FDA and GMP standards can 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 manufacturers’ data collection devices, ensuring full compliance with industry regulations.

Mettler-Toledo Safeline Metal Detection’s Tablex-PRO pharmaceutical metal detectors, for example, incorporate a data storage function that's easy for machine operatives to set up, due to a colour touchscreen and Windows-style icon-driven Human Machine Interface (HMI). This helps to reduce unnecessary downtime by making it simple for operatives to navigate the machine’s set up options with minimal training. On-screen histograms (graphical representations of the distribution of product inspection data) provide an easy-to-understand visual breakdown of performance and historical inspection records. Moreover, for multinational manufacturers, flexible connectivity interfaces simplify integration with external data collection systems, enabling the company’s entire production process to be monitored.

Best Practice 2: Cleaning up
To meet GMP requirements, the highest hygiene standards must be upheld on pharmaceutical production lines. To facilitate this, production line machinery designs must, where possible, avoid ledges, corners and flat surfaces that can act as dirt traps where excess layers of dust can accumulate. In addition, systems must be easy to clean, with modules that can be dismantled efficiently without the need for tools. At the same time, they must be made of robust materials, such as stainless steel, capable of withstanding harsh and repeated washdowns without succumbing to corrosion.

Compact metal detectors, with rounded corners and curved surfaces can streamline the cleaning process, enabling pharmaceutical manufacturers 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, facilitating regular hygiene inspections of every aspect of the machine. With the electrical components removed, the fully waterproof modules, made from mirror-finish stainless steel, can be fully submersed in water for optimal cleaning.

Best Practice 3: Operator training
To guarantee Best Practice, simply integrating data monitoring technologies, or easy-clean machines isn't sufficient. Machine operatives on pharmaceutical production lines must also be properly trained to ensure comprehensive data monitoring and cleaning take place and that such procedures are documented correctly.

Pharmaceutical metal detectors incorporating advanced HMIs with icon-driven displays help manufacturers ensure 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 reduces the risk of human error affecting data monitoring.

In addition, advanced metal detectors with built-in performance validation software 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 required by GMP Best Practice guidelines and to the standard expected.

Better than best
Complying with regulatory and industry standards for quality, traceability and safety is paramount to ensure product safety, as well as retain access to lucrative international markets. By following the three best practice guidelines in this article, pharmaceutical manufacturers can ensure they select metal detection systems that not only meet, but exceed GMP and PAT standards, achieving best practice on their lines whilst maximising the well-being of consumers.

For general information on
Mettler-Toledo Safeline, visit:http://www.mt.com/pi or http://www.mt.com/safeline-metaldetection
For more information on metal detection technology, call 022-42910209 or write to sales.mtin@mt.com