In this article, he explains how non-compliant seals might slip through the net and suggests that the solution to avoiding the contamination risk is actually very simple.
Mechanical seals perform a key function in pharmaceutical production processes and are vital to pump reliability. Yet, because they are regarded as component parts, they are often overlooked when it comes to compliance with US Food and Drug Administration (FDA) regulations and pharmaceutical current good manufacturing practices (cGMPs).
Crossover between the pharmaceutical, biopharmaceutical and food and beverage sectors is routine; the use of the dairy by-product ß-lactose as an excipient is a typical example. So, it makes sense that both cGMPs and the regulations governing food-contact materials (FCMs) must apply with equal weight in both sectors.
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.”
In other words, 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. So why is there a proliferation of mechanical seals in pharmaceutical processing plants with untraceable components — and what are the potential operational implications of installing them?
One answer lies in the often complex supply chains involved in the production of component seals that are currently being imported into Europe from Asia. An engineer or purchasing department tasked with buying in spare parts for repairs might presume that the original equipment manufacturer (OEM) may have bought the product from the lowest cost source.
What is less clear, however, is that to achieve this low cost, the product has often been through a number of links in the supply chain, meaning that by the time it arrives at the end user ... all traceability has been lost. And, without traceability, you have zero knowledge of the source material the seal is produced from. This constitutes a crucial knowledge gap.
Many mechanical seal faces are made from carbon. However, there are around 15 grades of commonly used carbon, of which only three are compliant with FDA standards. Of the remainder, approximately 10 are suited to chemical applications and don’t require FDA compliance; so, they’re fine for chemical, nuclear or power generation industries … but not for food or pharmaceuticals.
Finally, there are antimony carbons, which are used in the oil and gas industry and, put simply, are poisonous. It seems blindingly obvious that these should never come anywhere near a food or pharmaceutical supply chain but, incredibly, we have seen this type of carbon on pharmaceutical production sites.
Managing risk
The issue with these unsafe materials is that they look exactly the same as a seal that’s 100% 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 pharmaceutical company that conducts stringent checks at every step along the production line might be unaware that there are in fact a number of points of heightened contamination risk — 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.
For example, a pharmaceutical plant producing an API involving a wide range of rotating equipment could have as many as 15–20 mechanical seals and 60–100 static sealing joints throughout the whole production line. The more complex the process, the greater the number of seals, 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 into 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.
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 pharmaceutical production line.
Knowledge counts
With such a simple solution to ensuring compliance, why do pharmaceutical companies not apply it? Rather than wilful ignorance, the overwhelming issue is a lack of awareness … as well as inadequate communication between quality assurance personnel (and others responsible for compliance with FDA and EU regulations) and operatives 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 pharmaceutical production lines must be addressed. The failure to understand or act on the laws and regulations around traceability and labelling is a serious chink in the armour of an industry that can otherwise rightly pride itself on its high levels of quality assurance and self-regulation.
The message to company boards and CEOs is this: don’t assume that because you’re aware of FDA regulations and cGMPs that everybody within 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 how to do the simplest checks 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 that 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 pharmaceutical production lines becomes more than just a legal requirement … but a financial no-brainer to boot.
NB: This article will appear in the March 2019 issue of Manufacturing Chemist. A recent digital edition is available online.
