September 9, 2021 PAO-08-21-CL-07
Michael Moussourakis (MM): Alconox Inc.’s mission is to meet and exceed the critical cleaning needs of scientists and engineers. There are several different critical cleaning fields out there, ranging from biotech, pharmaceutical, and medical device to cosmetics, food and beverage, and cannabis, all of which have critical cleaning needs. By critical cleaning, we mean processes or products whose value is truly affected by the level of cleaning that can be achieved. We just proudly celebrated our 75th year anniversary as a family-owned business doing just that.
MM: I always analogize regular versus critical cleaning to a carpet in a conference room — as long as the carpet is reasonably clean, it’s not going to affect the quality of the presentation. However, the cleanliness of manufacturing a hip implant is very critical to its final value. Critical cleaning is when the value of the surface being cleaned is dependent on how clean it is. In other words, if the hip implant is not perfectly clean, it’s useless; you cannot implant it into the patient. We work with scientists, engineers, and lab analysts to ensure that their glassware, parts, and equipment are critically clean.
MM: Wherever there’s a critical cleaning need, wherever someone needs to get something cleaned to the point that there are no interfering or detectable residues left behind, that’s who we want to talk to –– in the world of biotech and pharmaceutical, that includes the whole range of small and large molecule chemicals and monoclonal antibodies, as well as injectables and of course many other products. There’s also a need for critical cleaning in the labs where people are doing testing and analysis with their instruments to detect proteins or other assays of that nature. Our customers encompass the whole industry; everyone from the janitorial and warehouse side, all the way through to final fill and processing, have cleaning needs. Very often, the same products that are used to clean the hard surfaces of the equipment can also be used to ensure that the cleanroom walls, the cleanroom flat surfaces and benches, and the manufacturing floors are just as critically clean.
MM: We always prefer to get involved at the beginning of a process, because there’s a chance that, once something has been designed or created, it may not be truly cleanable to the extent it might have been had we been consulted and advised on cleaning requirements earlier on. Oftentimes, we’re called to respond to an issue or cleaning challenge, which, as the solution providers we pride ourselves on being, are challenges we truly relish. But the best time is in the design stages of a product or process, so that we can recommend cleaning mechanisms, detergent chemistries, and operating parameters.
MM: We are critical cleaning and detergent focused. We understand that there’s more to this process than just the actual act of cleaning — there’s the setup and design to make it cleanable, the verification that the cleaning is done properly, and the formal validation. Alconox guides scientists and engineers through every aspect of critical cleaning. We also provide white papers and guidance documents for reference and often make onsite visits to key customers to ensure that EU- or FDA-regulated requirements are being met. Most importantly, we have a plethora of experience to draw from. Regulations change, but in general, the scientific approach to providing solutions that were appropriate yesterday is valid today. The chemistry still holds.
MM: Regulatory guidelines are constantly shifting and increasing, which is both an ongoing challenge and an opportunity. As different cleaning products are flagged as unsafe or as posing unnecessary risks for manufacturing technicians, they of course start to fall out of favor. Manufacturers then seek out alternatives to harsh solvents. While not hugely used in pharma and biotech, they are used in medical device, 3D printing, cannabis, and many other applications, especially alcohols. When you have the option of a flammable, corrosive, or hazardous solvent, versus a drain-safe, aqueous detergent, the EPA and other regulators are starting to really guide the industry toward safer products. We’re keeping up and working with vendors pioneering different cleaning and detection techniques and ensuring that we can support how our detergents are used and detected. Examples would include vacuum cycle nucleation as a cleaning technique and portable contact angle measurement as a detection method. In terms of other bigger-picture trends, 3D printing and cannabis are particularly noteworthy.
MM: We’re building up our cache of knowledge regarding 3D printing — also known as additive manufacturing — daily. The 3D printing industry itself is spreading to new frontiers almost daily itself. Part of what we do is study the substrates and the different materials that are used, in terms of compatibility and cleaning. Printed devices, especially in the medical device realm, can be very complicated. It’s easy to clean a simple solid shape like a cube or sphere, but for a heart valve or other organ replacement devices with all sorts of intricate, convoluted, or tortuous pathways — there’s a lot of consideration involved in ensuring that all internal parts are critically clean. For instance, there are technologies that rely on vacuum cycle nucleation, in which the material is cleaned from the inside out because a vacuum is pulled on the fluid. There are also low-foaming, low–surface tension aqueous detergents that can reach small internal diameter areas, including medical guidewires. Most recently — and I saw a great article on this subject in Pharma’s Almanac recently — 3D printing is evolving into pharmaceutical manufacturing. Much of this was science fiction just a few years ago.
MM: The cannabis industry is looking to evolve from the harsh (i.e., flammable) solvents, such as acetones, isopropyl alcohol, and ethanol, that have traditionally been used to clean. This is of course a good thing for several reasons. An aqueous detergent is a cheaper, less hazardous, and often more effective way to clean. Solvents offer one avenue of attack; they dissolve and will either work or not, whereas detergents involve chelation, sequestration, dispersion, and emulsification, which come together to create a cost-effective, synergistic product. A second message is to keep an eye on regulations, especially those of the food and beverage industry and the pharmaceutical industry. Cannabis products are essentially a blend of those two well-regulated industries, and regulations may ultimately be a hybrid of those two sectors.
MM: Whether it be the cannabis or other industries that may not have had the same level of regulatory scrutiny in the past as medical device, biotech, pharma etc., when aqueous detergents are implemented, rinsing can be forgotten about. Most tend to think about cleaning in their own residential setting, where solvents abound — think glass cleaner — and where rinsing isn’t necessary. This is because your mirror or window at home don’t need to be critically clean. Further rinsing is just a part of the picture. At Alconox, we discuss nine variables of cleaning, everything from what is done before the cleaning process through rinsing, drying, and clean part storage. The process should be thought of as a life cycle.
Ultimately, the importance of getting away from harsh solvents can’t be overstated. The EPA has begun to flag many of these as inappropriate and an unnecessary risk to workers. One simple way to think about solvents versus aqueous solutions is spray glass cleaner versus dish soap. Bathroom mirrors still harbor dirt even after being cleaned with your favorite spray-on glass cleaner, because, although oils are dissolved, the build-up is spread around during wiping instead of actually being displaced and removed. If you rely on your typical dish detergent, a deeper clean is achieved, and the tied-up oil and other residues in solution are carried away in the rinse. (It should be noted that a lot of dish soaps also contain emollients and scents that Alconox products don’t have. They don’t get rinsed away so easily, so the metaphor isn’t perfect.) The rinsing step following the application of an aqueous cleaner is a critical piece that companies with solvent cleaning procedures have to ensure isn’t overlooked.
All of the pharmaceutical and laboratory Alconox detergents are safe to send to drains from a federal standpoint, though each municipality differs (e.g., what is allowable in rural Maine as opposed to southern California). We’re regularly approached about disposing detergents, and we inform clients to follow both local rules and federal guidelines. All of our detergents are biodegradable, and even our most acidic and alkaline cleaners are less harsh than residential-type drain and oven cleaning products available at grocery stores.
MM: There are a few basic principles in play: for organic and oily residues, you want to use an alkaline-based detergent. For anything inorganic, like salts, oxides, or anything that’s acid-labile, which inorganic molecules tend to be, you typically want to use an acidic detergent. While this is the basic premise, there are many exceptions. Knowing how to address the exceptions is where the value of our expertise is key.
Collagen, for example, swells in the presence of alkaline. One would think that, as an organic, biologic residue, you would go with a moderate or higher pH. Of course, this swelling makes cleaning more difficult, so, in that instance, we break the organic–alkaline “rule.” We would recommend cleaning with an acid-based cleaner with an emulsifier. This emulsifier will also help remove any other oily organic residues around. The word “synergy” can be overused, but a detergent really is best described as a synergy of different mechanisms.
Enzymes can also be added to detergents; the alkaline or moderately alkaline detergents that are approximately pH 9 can be enhanced with a protease to help facilitate the removal of a biologic residue. One of our flagship healthcare detergents for medical devices has a moderate pH, but, being enhanced with a protease, it acts like a much more powerful detergent though only moderately alkaline.
Another key principle is like cleans like. If there’s an unknown residue or compound, in addition to confirming whether it’s an organic or inorganic, it’s critical to find out whether it is acid or an alkaline based. By following the “like cleans like” rule, you can also decide whether to use a higher- or a lower-pH product. The pH aspect goes a long way in cleaning decisions. Temperature is another aspect that can’t be overlooked. In the vast majority of cases, temperature accelerates cleaning. We have a rule of thumb — approximately every 10 degrees Celsius or 20 Fahrenheit halves the cleaning time — or doubles the cleaning speed. It’s a powerful concept. If you talk about ambient temperature compared with an elevated temperature – say 20 °C vs. 60 °C, there’s a lot of halving of the cleaning time. Like every other rule, of course, there are exceptions. Residues such as titanium dioxide and zinc oxide react poorly to heat. They form titanates and zincates, which are more difficult to clean.
While general principles guide the cleaning process, there are so many specific exceptions that we always want to interface directly with our clients to provide the best science and ensure that the most optimal cleaning is achieved. Alconox doesn’t sell capital equipment at this time; we provide the detergents and the guidance to use them; that is our sole interest.
MM: It’s important to continually innovate with new detergents and technologies, including surfactants and dispersants. We’re also focused on achieving a more efficient and effective clean. If you scrub at high heat for a long time and add a lot of detergent, sure, you’ll get the job done — but it might not be the best method. We consider the variables: can the cleaning be done at an ambient temperature with less detergent? Can we do it with a detergent at a more neutral pH? Can we use a detergent that is not only biodegradable but is also quickly biodegradable? We stay ahead of these factors to meet and exceed the demands of our customers.
Ensuring that detergents are compatible with different polymers and substrates while being effective with all types of residues requires constant evolution. At Alconox, we feel that it is vital to visit customers to learn about their needs, pain points, and cleaning challenges. With the EPA homing in on harsh solvents, we’re committed to being able to respond. The cleaning industry is moving away from things like N-propyl bromide and instead relying on highly emulsifying detergents. I think that’s probably the biggest new thing: the influx of critical cleaning opportunities as certain industries, including medical device, pharmaceutical, and others, are moving away from the solvents of the past and toward the drain-safe, aqueous, biodegradable detergents of the future. There are also more intricate residue-detection methods now than ever before, which are demonstrating that materials aren’t getting as clean as we had previously imagined, which makes cleaning even more deeply essential. Ultimately, the needs and safety of all stakeholders, including the workers, patients, and end-users, are paramount, which is why Alconox strives to ensure that our clients are able to meet the absolute most stringent cleanliness standards possible.
Michael Moussourakis is a Senior Director, Technical Marketing and Strategic Affairs at Alconox Inc. headquartered in White Plains, NY. The Marketing team provides tactical and product leadership to Alconox, Inc. customers for their critical cleaning needs. He has over 20 years experience in the biotech, pharmaceutical, medical device and laboratory industries. Through various and progressive roles in technical, tactical marketing and product management, he has contributed via publications, training, and committee participation. Michael’s technical expertise covers critical cleaning, biopharmaceutical filtration and process troubleshooting. Michael holds a BS and MS in Biomedical Engineering from the Columbia University.