Pharmaceutical companies are unwittingly putting production processes at risk of contamination by fitting mechanical seals which fail to comply with EU regulations. says John Smiddy, European Sales and Technical Support Director for AESSEAL. Here he explains how non-compliant seals might slip through the net and suggests how the issue can be resolved.
Contamination
The regulations relating to mechanical seals in pharmaceutical production processes couldn’t be simpler: every component in contact with an active pharmaceutical ingredient (API) must be 100% traceable and a statement of compliancy must be clearly marked on the packaging it comes in.
Crossover between the pharmaceutical, biopharmaceutical and food and beverage 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 both pharmaceutical current good manufacturing practice (cGMP) and regulations governing food contact materials (FCMs) must apply with equal weight in both sectors.
John Smiddy, European Sales and Technical Support director for AESSEAL
John Smiddy
Regulation (EC) 1935/2004 on FCMs is unequivocal: “A name, reference number and batch or delivery number should identify each raw material, so that it can be traced, if necessary. The traceability of raw materials is achieved throughout the production chain and in-house by the delivery and/or batch reference numbers. It is a legal requirement that traceability exists at least to the level of one stage back and one stage forward.”
So, why is there a proliferation of mechanical seals in pharmaceutical processing plants whose components cannot be traced — and what are the potential operational implications of installing them?
Understanding supply chains
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) has sometimes bought the product from the source offering the lowest cost. What they might not be aware of is that to achieve this low cost the product has often been through so many links in the supply chain that by the time it arrives at the end user all traceability has been lost. And if you have no traceability you have zero knowledge of the material the seal is produced from.
Let me give you just one example of the importance of knowing the source material of a seal.
Many mechanical seal faces are made from carbon. However, there are around 15 grades of carbon commonly used. Of these there may be only three that are compliant with Food and Drug Administration (FDA) standards. Of the remaining carbons around 10 are suited to chemical applications and don’t require FDA compliance so, fine for chemical, nuclear or power generation industries but not for food or pharmaceutical.
Finally, there are antimony carbons, which are used in the oil and gas industry and, put simply, these are poisonous. It seems blindingly obvious that these should never be used anywhere near the food or pharmaceutical supply chain but incredibly we have seen this type of carbon on sites where the implications of them being misapplied could be disastrous.
The problem with all these materials is that they all look exactly the same as a seal that is 100% traceable and compliant. You simply cannot differentiate between a compliant and non-compliant seal — unless you have its traceability clearly stated on the box it comes in.
The potential risk implications of installing untraceable mechanical seals can’t be overstated. A pharmaceutical company that carries out stringent checks at every step along the production might be blissfully unaware that there are in fact a number of points of heightened contamination risk along that line — one for every seal.
The standard for compliance on site is often focused on the end-product yet 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 pharmaceutical plant producing an active pharmaceutical ingredient (API), involving lots of different rotating equipment, that could mean 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.
There is a 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 seal comes in packaging that doesn’t clearly state its source, don’t use it.
ASSEAL image
Less scrupulous companies might claim to have traceability and as FDA auditing fails to cover the supply chain of the materials there are no proper checks and balances to demand proof.
But Regulation EC1935/2004 is clear — if that traceability is not visibly evidenced on the packaging those claims carry no validity and the mechanical seal should not be installed on a pharmaceutical production line.
That rule of thumb might sound not just simple but blindingly obvious, but that doesn’t mean all pharmaceutical companies apply it. Why not?
Lack of awareness
Lack of awareness is the overwhelming issue, as well as lack of communication between quality assurance and others responsible for compliance with FDA and EU regulations and operatives and at the lower ‘repair and replace’ end of the production line.
The need to pay equal attention to spare parts when considering quality compliance is often overlooked. This is compounded by the need for expediency when repairs are required. Getting a production line back up and running means engineers may be less focused on regulations in the effort to avoid costly downtime.
For mechanical seal suppliers like AESSEAL compliance is an issue of integrity as well as law. The number of times we’ve encountered non-compliant seals makes it clear that their proliferation is an issue that must be addressed.
My message to company boards and CEOs is: don’t assume that because you’re aware of the EU regulations that everybody across your company is too. Check that your quality assurance manager is aware of the need for clearly labelled traceability. Then make sure that they trickle that information all the way down the production line team so every member knows what constitutes compliance and how to carry out the simplest checks on packing and labels to ensure that products adhere to it.
The pharmaceutical industry can rightly pride itself on its high levels of quality assurance and self-regulation, but the failure to understand or act on the laws and regulations around traceability and labelling is a serious chink in its armour.
With a solution so blindingly obvious there should be no excuses for installing non-compliant mechanical seals in any pharmaceutical production plants.