If you’re involved in pharmaceutical manufacturing or any other sanitary industry, you just cannot do without effective, high quality CIP systems. You could invest in the most sophisticated process vessels, heat exchangers and purified water generation systems out there, but if your CIP systems fall short, all of that investment will be for nothing. Naturally, there is a reason why CIP systems fall short on occasion – sometimes, the cost of CIP systems is perceived as a barrier to profitability. But in this article, we’re going to show you just how inaccurate that perception is. The cost of clean in place systems is justified by the tremendous gains that they provide in terms of safety, time, resources, and convenience.
Clean in place systems are the furthest thing from a luxury for pharmaceutical manufacturers. Of course, it’s possible to do without them, but not if you want to manufacture safe and quality pharma products in the cheapest, quickest and most efficient way. Think of the cost of CIP systems not as an extra expense, but as an investment in your success and your customers’ health.
What is CIP?
Sterility in pharmaceutical manufacturing in a non-negotiable. The specific requirements for sterile manufacturing vary based on the product in question – for instance, vaccines, enzymes, and other parenterals have far stricter standards than oral solid dosages. But in all cases, cleaning and sterilizing your equipment forms the foundation of producing safe pharma products.
About a hundred years ago, drugmakers would have relied on human beings to take apart machinery, clean and sterilize it, and put it back in place for the next round of pharma production. But as you can imagine, that was an extremely tedious process, not to mention the contaminants that could have made their way into the system during the process of re-assembly.
But around the 1950s, a revolution began. Clean in place, or CIP systems began to become increasingly common. Accompanied by SIP, or sterilization in place systems, they were able to ensure improved compliance with international regulations, reduced downtime, lower water and detergent consumption for cleaning, and much less tedious manual labour and much fewer risks for factory staff.
As you would have guessed by now (and as the name of the process suggests), clean in place refers to the process of cleaning your pharmaceutical equipment without moving or dismantling it.
The CIP process generally involves the preparation and delivery of cleaning agents to every piece of equipment that comes in contact with your raw materials – this includes you storage tanks, compounding vessels, piping systems, and more. An initial rinse cycle is followed by cleaning with specific chemicals, a detergent wash, disinfection, and a final rinse or two. All of these steps are carefully maintained and monitored for temperature, pressure, and flow velocity. CIP is carried out before every production cycle begins to ensure that no residue from the previous cycle is left behind.
The choice of chemicals and other cleaning agents used must be made carefully. The agents should be capable of clearing all possible contaminants from tanks, pipes, and other equipment. Further, any cleaning agent residues in the equipment must be flushed out well in the final rinse. Some of the cleaning agents best suited to CIP are caustic soda, nitric acid, phosphoric acid, peracetic acid, sodium hypochlorite, and chlorine dioxide.
Clean in place is followed by sterilization in place; the two processes of CIP and SIP go hand-in-hand because the chemicals used for cleaning must be eliminated completely. Sterilisation in place gives you the sky high levels of sterility that you need in pharma manufacturing.
CIP Systems that are Worth Investing In
So now you know how CIP works – can you get straight into shopping for one? Not quite.
The efficacy of a CIP cycle can mean many different things to pharma manufacturers making different products. Accordingly, the specifications that you would want to justify the cost of CIP systems for you would differ. But largely, there are some fundamental features that common to all state-of-the-art CIP systems.
Installing clean in place systems can be a substantial part of your CAPEX. So what features justify the cost of clean in place systems? You can decide which CIP systems are worth investing in using this list. The best CIP systems…
… provide the best possible cleaning in the least amount of time. One of the main perks of investing in CIP is saving time. So if your CIP system isn’t giving you the advantage of lesser downtime, you should consider switching to a more efficient one.
… have tailored process specifications based on the nature of residues that need to be cleaned. The cleaning agents used as well as the pressure and turbulence of flow must be adapted to your operations.
… ensure uniform exposure of the CIP fluids to all surfaces in the system. This means that the cost of CIP systems includes the cost of cleaning not just tanks and machines, but also piping, valves, gauges, and more. This also means that there are appropriate drainage mechanisms and there are no dead legs or crevices that are inaccessible to CIP cleaning fluids, or spaces where liquids might stagnate.
… result in minimal energy losses from overheating, exothermic reactions, or cavitation in pumps.
… have construction which is durable enough to withstand extreme changes in temperature and pressure. The cleaning process shouldn’t result in sagging pipes or equipment damage.
… offer customisations when it comes to skid systems, tank, hex, dosing systems, pump design, and number of tanks (single or dual). Metering and dosing pump systems contribute not only to precision, but also to the safety of the people who work with the equipment.
… come with all the documentation you need to ensure effectiveness and longevity. This includes a complete qualification and validation package as well as annual maintenance contracts that make equipment upkeep routine.
Beyond just CAPEX
Finally, the cost of clean in place systems is beyond just monetary. What do we mean by this?
Time – think about how reduced downtime for maintenance means that your production lines can run for longer. This will enable you to produce more parenterals or generate more pure steam or purified water in shorter durations of time. Overall, this adds to your productivity and profitability.
Cost optimisations – the cost of clean in place systems will be offset by the reduced cost of labour, higher throughput, and water and detergent consumption.
Process protection – the reduction in the risk of errors, contamination and accidents comes as an added protection for your equipment, your people, and your bottom line that doesn’t have to suffer from unexpected breakdowns or productivity loss.
Environmental health – we’ve talked about the cost of clean in place systems in terms of only product features and specifications, but there is one added cost you should consider when accounting for the cost of CIP systems for you: wastewater handling. When water containing cleaning chemicals is released into the environment, it has disastrous effects on the health of the environment and the communities in the region. There are rules and regulations about how such water should be treated, released or disposed of. Managing your own industrial waste is not a responsibility you can or should shrug off. Budget for appropriate wastewater management processes or an environment-friendly CIP strategy in advance so that you don’t harm the planet in pursuit of profits.
That’s our guide to understanding the true cost of clean in place systems. Use it as a blueprint to make informed CIP-related decisions and you’re sure never to falter as you navigate the perilous landscape of safety and sterility in pharmaceutical manufacturing.