Sanitation is a paramount concern for equipment used in pharmaceutical manufacturing, with even low contamination levels putting products at risk of spoilage and endangering consumers. Unfortunately, the pipes and water systems used in pharmaceutical manufacturing facilities are often ideal breeding environments for biological contaminants and pathogens, which can sometimes accumulate on the surface of equipment as biofilm.
Biofilm is a stubborn aggregation of microorganisms that grow on a solid surface, usually encased in a hard self-sustaining matrix of extracellular polymeric substances, or EPS, that makes the biofilm difficult to remove by conventional means. Biofilm microorganisms include fungi, algae, and bacteria, with the tough outer ‘film’ protecting them and enhancing their survival.
Pharmaceutical water systems can suffer from long-term operational problems caused by biofilm. Taking proactive steps to remove biofilm can minimise downtime, maintain sanitation in your facility, and keep production on schedule. Regular biofilm removal and maintenance ensure optimal performance and compliance with the Medicines & Healthcare Products Regulatory Agency (MHRA).
Biofilm can also physically damage your pharmaceutical equipment, water systems, and pipes, producing corrosive substances that degrade metal and other substrates, and compromising their safety and efficiency.
Biofilm can be removed from the water system either by mechanical cleaning to dislodge the biofilm, or a chemical treatment. Please note that removing biofilm often requires a multi-stage chemical cleaning process. This would typically include a hot alkaline wash, followed by a hot acidic wash - and finally a sanitisation with hydrogen peroxide or chlorine based product.
Once the film is removed, a biocide wash will help eliminate residual microorganisms and minimise regrowth. It’s important to regularly monitor equipment for the early signs of biofilm and sanitise water services at regular intervals to avoid the potential system damage caused by biofilm.
To an extent, yes. Routine cleaning and disinfection can help prevent the formation of biofilm on pipes and surfaces.
Effective system design is vital. Dead-legs or sections of pipework that have low-velocity flow are more vulnerable to biofilm formation. It is critical that product contact surfaces are as smooth as possible as to reduce crevices or scratches where biofilm can take hold. This includes ensuring that rouge is removed as and when it forms - as rouge is composed of crystals of iron oxide that will give bacteria a rough surface to adhere to.
If you've noticed the warning signs of biofilm on your equipment, or are concerned about corrosion, compliance, or performance, take action as soon as possible to remove the biofilm. You will also need to remove biofilm if you intend to passivate or derouge your equipment. Incorporating biofilm removal into your regular planned preventative maintenance schedule will help maintain longevity and compliance and protect your operation from potential setbacks.
If you are concerned about biofilm removal or would like to find out more, please contact our team for expert advice today.
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