22 mechanical seals
CHECK YOUR LABELS TO ENSURE COMPLIANCE
John Smiddy, European Sales and Technical Support Director for AESSEAL, explains how mechanical seals can pose a serious contamination risk on pharmaceutical production lines – and how that risk can be avoided.
M
echanical seals play a crucial role in pharmaceutical production – preventing leakages from process pumps which could lead to costly downtime and
and do not require FDA compliance, and finally there are antimony carbons, which are used in the oil and gas industry. Put simply, these are poisonous and should never appear anywhere product loss. near pharmaceutical Yet, because they are component parts, seals are industry pumps. Despite often overlooked when it comes to compliance with this, we have seen this Food and Drug Administration (FDA) regulations and type of carbon being used pharmaceutical Current Good Manufacturing Practice on pump systems within (CGMP). pharmaceutical sites. As a result, many manufacturers are unwittingly It is important to be aware that component specifying mechanical seals manufactured from seals being imported into non-safe materials and this creates a very real risk of Europe from Asia can have contamination. been through so many There is routine crossover between the chemical links in the supply chain, that when it reaches its final compounds and ingredients used in pharmaceutical, destination, any traceability may be lost. biopharmaceutical and the food & beverage sectors – Crucially, a seal made from unsafe materials will look the use of the dairy by-product β-lactose as an excipient identical to a seal which is 100% compliant. They can is one typical example. So, it does make sense that only be differentiated if their traceability is clearly stated both CGMP and the regulations governing food contact on their packaging. materials (FCMs) must apply with equal weight in both As a result, a pharmaceutical company which sectors. otherwise carries out stringent checks at every step of Regulation (EC) 1935/2004 on FCMs is unequivocal: production might be unaware that there are a number “A name, reference number and batch or delivery number should identify each raw material, so that it can of points of potential contamination risk – one for every pump fitted with non-compliant mechanical seals. be traced, if necessary. The traceability of raw materials There are genuine reasons why companies fail to is achieved throughout the production chain and intackle this and that is down to risk. A lack of awareness, house by the delivery and/or batch reference numbers.” as well as poor communication between those In other words, every component in contact with responsible for compliance with FDA and EU regulations an active pharmaceutical ingredient (API) must be and operatives at the 100% traceable ‘repair and replace’ end and a statement of of production. compliancy must be But Regulation clearly marked on EC1935/2004 is its packaging. That clear – a mechanical includes mechanical seal is non-compliant seals. if traceability is not visibly evidenced on SOURCE the packaging and it MATERIALS should not be installed The main problem on a pharmaceutical lies in the complexity production line. of source materials The conclusion is and supply chains. surely that, to avoid There are, for both the risk of example, around 15 contamination and of grades of carbon falling foul of the law, commonly used in the always look at the label! manufacture of seal And, if a seal comes in faces, of which only a packaging that does handful are compliant not clearly state its with FDA standards. Every component in contact with an active pharmaceutical source, don’t use it. chevron-circle-right Of the remainder, ingredient must be 100% traceable and a statement of some are suited to compliancy must be clearly marked on its packaging. www.aesseal.com chemical applications
Quarter 1 2020
“Crucially, a seal made from unsafe materials will look identical to a seal which is 100% compliant.”
www.bpma.org.uk
