FEATURE PROCESS SAFETY ELIMINATE THE RISK OF CONTAMINATION


John Smiddy, AESSEAL, explains how mechanical seals can pose a hidden, but serious, risk on production lines and suggests how food, drink and pharmaceutical producers can ensure compliance with EU regulations


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liminating the risk of contamination is high on the agenda of every responsible food, drink or


pharmaceutical producer. Yet many pumps on production lines are fitted with mechanical seals which fail to comply with EU regulations. Mechanical seals are a small but significant


component of food processing equipment, fitted to pumps at any point along the production line. They play a key role in sealing rotating equipment to ensure machinery runs reliably and that products remain free of contamination. But it can be easy to overlook their relevance in


the overall scale of operations, and there is a knowledge gap in the industries around key pieces of regulation which cover mechanical seals, including Regulation (EC) 1935/2004 on food contact material and Regulation (EC) 2023/2006 on good manufacturing practices for materials and articles intended to come into contact with food. As a result, mechanical seals manufactured from non-safe materials are routinely specified, creating a very real risk of unsafe materials coming into contact with consumables. Regulation (EC) 1935/2004 on food contact


materials (FCMs), states unequivocally that any mechanical seal on a food and drink production line must be 100 per cent traceable and a statement of compliancy must be clearly marked on the packaging it comes in. In other words, every component in contact with


consumables or an active pharmaceutical ingredient (API) must be 100 per cent traceable and a statement of compliancy must be clearly marked on the packaging it comes in. Crossover between the food and beverage,


pharmaceutical and bio pharmaceutical sectors is routine – the use of the dairy by-product β-


lactose as an excipient is a typical example - so it stands to reason that the regulations governing food contact materials (FCMs) must apply with equal weight in these sectors. So how are potentially unsafe seals creeping into


production lines which otherwise have stringent safety mechanisms in place and what are the implications of installing them? First, it helps to understand the often complex


supply chains involved in the production of component seals currently being imported into Europe from Asia. An engineer or purchasing department tasked


with buying in spare parts for repairs might take it for granted that the Original Equipment Manufacturer (OEM) may have bought the product from the lowest cost source. However, they might not be aware that to achieve this low cost, the product may only have US FDA approval and as such may still not be legally EU compliant. Many mechanical seal faces are made from


carbon. However, there are around 15 grades of carbon commonly used in the manufacture of mechanical seal faces. Of these there may be only three that are compliant with Food and Drug Administration (FDA) standards. Finally, there are antimony carbons, which


are used in the oil and gas industry and, put simply, are poisonous. It is obvious that these should never be used anywhere near the consumables or pharmaceutical supply chain but incredibly this type of carbon has been used on sites where the implications of them being misapplied could be disastrous. The issue with these unsafe materials is that they


look exactly the same as a seal which is 100 per cent traceable and compliant. You simply cannot differentiate between a compliant and non- compliant seal unless you have its traceability clearly documented on the packaging it comes in. As a result, a company that carries out stringent


checks at every step along the production might be unaware that there are in fact a number of points of heightened contamination risk along that line - one for every seal. And a non-compliant mechanical seal can create a risk at every stage of the production process, from beginning to end. If we take the example of a pharmaceutical plant


producing an Active Pharmaceutical Ingredient (API) involving a wide range of rotating equipment – that could have as many as 15 to 20 mechanical seals and 60 to 100 static sealing joints across the whole production line. The more complex the process, the greater number of seals and the greater the risk of product contamination and, in the worst-case scenario, product recall. Thankfully, there is a blindingly simple solution


to what effectively amounts to building risk in to production processes at the same time as breaking the law. Look at the label. And if the


24 AUTUMN 2019 | INDUSTRIAL COMPLIANCE


seal comes in packaging that does not clearly state its source, do not use it. The failure of FDA auditing to cover the supply


chain of materials means there are no proper checks and balances to demand proof, leaving the way open for less scrupulous companies to claim traceability where there is none. But Regulation EC1935/2004 is clear - if


traceability is not visibly evidenced on the packaging those claims carry no validity and the mechanical seal should not be installed on a production line. Checking a product label might seem not just


simple, but blindingly obvious. However, that does not mean that all companies apply it. Lack of awareness rather than wilful ignorance is


the overwhelming issue. There is often a lack of communication between quality assurance for compliance with FDA and EU and operatives responsible at the repair and replace end of the production line. The failure to pay equal attention to spare parts when considering quality compliance is compounded by the need for expediency when repairs are required. Engineers working to get a production line back up and running are less focused on regulations than the need to avoid costly downtime. But the issue should be one of integrity as well as


the law and the proliferation of non-compliant seals on food, drink pharmaceutical production lines must be addressed. Failure to understand or act on the laws and regulations around traceability and labelling is a serious chink in the armour of industries known for their high levels of quality assurance and self-regulation. CEOs should take some responsibility here - do


not assume that because you are aware of FDA regulations and CGMP that everybody across your company is too. Ensure that your quality assurance manager is aware of the requirement for clearly labelled traceability and make sure they trickle that information all the way down the production line team, so every member knows what constitutes compliance and carries a simple check on packing and labels to ensure that products adhere to it. There is of course another logic to seeking out


guaranteed compliant products. A seal manufacturer which has invested in ensuring its products are made from Generally Recognised as Safe (GRAS) materials is also highly likely to have invested in the most advanced technology to ensure optimum quality and reliability. When a commitment to ensuring compliance is


coupled with a swift return on investment and long-term operational savings, the argument for reviewing the mechanical seals on production lines becomes not just a legal requirement but a financial no-brainer to boot.


AESSEAL www.aesseal.com / INDUSTRIALCOMPLIANCE


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