It goes without saying that if you are a pharma or biopharma manufacturer anywhere in the world, safety and quality are your top priorities. A production line with a stupendously high capacity or a vast range of pharmaceutical products is pointless if the fundamentals of sterile manufacturing, cleaning, sterilisation and contaminant-free processes are not followed.
Clean-in-place systems, or CIP systems, are far from a luxury or privilege in pharmaceutical manufacturing. Given the criticality of sterile manufacturing while producing drugs, vaccines or any other pharma or biopharma product, a CIP system is a mainstay of your production process. A CIP system in pharma is not an option; it is a necessity. And choosing the right one for you is an important decision that you should make early on in the process.
What are CIP systems?
CIP, or clean-in-place, refers to the process of cleaning your pharmaceutical manufacturing equipment without the need to move them from the position they are in. As opposed to older cleaning methods – which involved disassembling equipment before cleaning it manually, and then reassembling it manually – CIP systems are enormously more convenient, effective, and time-saving. They also eliminate the need for manual labour and the risks and challenges that come with manual dismantling and reassembly. And with more thorough cleaning, lower water and cleaning agent consumption, as well as the minimisation of downtime for process equipment, CIP systems have a huge number of benefits to offer.
Once you select and install the right CIP system (and SIP system) from TSA, you will see the benefits for yourself, and there will be no going back.
What does the CIP and SIP process look like?
Clean-in-place and sterilise-in-place processes often go hand-in-hand to ensure that all contaminants and residues are eliminated and your equipment achieves the high level of sterility required by the pharma industry.
The CIP process ordinarily involves the preparation and delivery of cleaning agents to your tanks, machines and piping systems. A rinse cycle is succeeded by cleaning using specifically chosen chemicals, a detergent wash, disinfection and a final few rounds of rinsing. These processes occur at specific temperatures, with water and other substances flowing through with a velocity that is sufficient to clear all kinds of residue and contaminants. This process must be carried out between production batches to ensure each fresh batch does not carry any trace of the previous one.
What types of CIP system are out there?
The integrations and customisations that you can get with the types of CIP system available out there – no matter if you produce injectables, biosimilars, oral solid dosages, or other parenterals – will completely transform the throughput and productive capacity of your manufacturing line.
CIP systems, especially the ones made by TSA, offer a wide range of customisations. If you are looking for a CIP system in pharma, TSA’s range provides tailored solutions which come with or without tank, hex and dosing systems. You can also get CIP systems with single or dual tank and/or pump designs. Metering and dosing pump systems, in addition to all the other features of a CIP system, not only prevent your people from exposing themselves to toxic, corrosive cleaning agents, but they also provide an unparalleled level of accuracy by automatically adding chemicals in precise quantities to your CIP system.
Depending on the scale of your production facility, CIP skid systems may also be the correct choice for you. CIP skids are modular systems which can be fabricated with a single- or multi-tank framework. The overall size and scale of the CIP skid system will depend on the size and number of tanks and process piping to be cleaned. Considering their modular nature, CIP skids usually come with a level of chemical dosing, a heat exchanger as a source of thermal energy, and the pumps, valves and controls required for the distribution of cleaning materials.
Customisations to your CIP skid systems can also include either centralised or local recirculation skid modules and combinations of CIP and SIP systems. And considering that TSA cares about improving your facility’s safety, speed and effectiveness, you can get your CIP and SIP integrations with a complete qualification and validation package.
How to choose the right CIP system for your facility
Depending on your priorities, an effective CIP system may look very different for you as compared to another pharma producer, with both your preferred specifications dependent on the type of pharma product you are making. But in general, here are a few factors you should consider as you make the decision of investing in whichever types of CIP system in pharma you prefer.
- Your CIP system of choice should address the cleaning needs of not just your compounding and holding tanks, but also of all the piping, valves, hoses, filtration skids, pumps and other elements that come in contact with your raw materials or finished products.
- Your piping and CIP/SIP systems should have no dead legs, crevices or corners which can become a comfortable home for microorganisms or other contaminants or residues. Such dead legs may also be inaccessible to your cleaning agents, thereby greatly increasing your risk of product contamination.
- The main perk of CIP and SIP systems is the reduced downtime for maintenance. This allows you to operate your machines for longer and improve your productivity. So to capitalise on this benefit, you want to make sure that your CIP system and SIP system are not so overly complex that they add to your maintenance time. Good CIP systems provide the best possible level of cleaning in the shortest amount of time.
- Your CIP system should be tailored to the nature of the residues you are expecting to clean. This will determine the temperature, velocity and chemicals you should use to ensure thorough cleaning.
- CIP and SIP procedures involve temperature and pressure changes. And temperature and pressure changes can cause energy losses, sagging of pipes, as well as their contraction or expansion. You want to make sure that your CIP system is designed to work around these conditions.
- Finally, most importantly, ensure that your CIP and SIP systems have proper drainage capabilities. This is critical to effectively maintain the sterility of the system.
At TSA, sterile integrity is our foremost priority. The integrations for CIP and SIP that we provide cover the entire length of the production line so that every surface that comes into contact with your APIs, excipients, purified water and other substances is subject to thorough cleaning and sterilisation. Our cutting-edge technology not only incorporates static and dynamic spray balls, depending on your preference, but it also works in concert with the required temperature, time duration and spray concentration to deliver a cleaning process that you would be proud to have at your manufacturing facility.