Fully Scalable, Lab-Sized Pharma Milling Equipment Was Never Easier to Operate (And Never Looked So Good!)

Formulation, R&D and Oral Solid Dosage pharmaceutical laboratories worldwide are being challenged with investing in equipment that affords more versatility, diminishing budgets and compressed timelines to – safely and reliably – scale up from small lab and pilot runs to full production. Now, with the introduction of the SLS – SCALABLE LAB SYSTEMTM, The Fitzpatrick Company and Quadro Engineering Corp. have combined decades of expertise in manufacturing lab-scale powder size reduction mills into a one-stop solution. For years, pharmaceutical formulation and R&D laboratories have, at times, looked like supermarkets full of “goodies” – both small and sometimes not so small equipment. These facilities had an apparatus for every conceivable powder processing challenge. If one stays with the grocery store analogy, then the lab benches could have been equated with the confectionary aisles; full of sweet and fun-to-have machinery, although not always the “healthiest” investment. Over time, R&D spending budgets have slowly decreased in favour of very targeted and focused return-for investment calculations and pay-back analysis; before a single penny is spent. The practice of having a complete proposal that would explain to senior management the benefits of a particular technology over another and “why” it is important to invest in said technology, is now followed more rigorously than ever. And rightly so, when budget restraints are as common as catching a cold, making the best choice really matters when available funds are continually dwindling. Enter the SLS – Scalable Lab SystemTM, a lab-sized drive platform that enables users to have four (4) different milling/de-agglomerating technologies in one machine. Why? The answer is simple – flexibility, versatility and a reduction in capital investment. But that is not all. Having interchangeable milling heads with a single drive mechanism offers additional benefits such as a “reduced footprint, half the training, less documentation and an easy comparison of performance on mill types…*I am+ really happy with this”, as Dr. John Robertson, Senior Research Fellow at the University of Strathclyde, Glasgow, UK put it. The concept of interchangeable milling heads for a lab environment is not new. It was first introduced by The Fitzpatrick Company in 2003 and featured the combination of the L1A FitzMillTM/FitzSieve FS75 conical mill. In 2011, as synergies between Fitzpatrick and Quadro Engineering grew stronger, the conical milling head was changed to the very popular Comil® Model U5. It is as if we took our grocery cart away from the bonbons and cookies, and headed towards the organic health food section; a shift from traditional to avant-garde, from “one machine for one operation” to one core solution with multiple outcomes. Zoetis, USA describes this benefit as follows: “In our lab area, we often have to move pieces of equipment in and out of modules in order to complete a process. With a single unit, we can reduce the number of trips into and out of the module” Dr. Robertson further notes, having swappable heads goes beyond the reduced investment benefits, “we have used this [L1A/U5 combination lab mill] typically weekly on average since installing it and across a wider range of applications than initially envisaged, having the two mill heads and ease of change etc. lets us do more in a busy facility, with limited space”. Today, the milling head interchangeability concept has culminated in the SLS – Scalable Lab SystemTM, which, as the name depicts– is truly a system whereby four (4) interchangeable heads enables five (5) different processing solutions (one of the milling modules serves a dual purpose). With the ability to switch in seconds, from a FitzMillTM hammermill to a Comil®(or High Efficiency Comil®) to a deagglomeration/FlexSift security screener, or a High Speed H5Comil®– the benefits are self-evident. An operator can test the same product with four (4) alternate size reduction technologies and compare the performance, the particle size distribution, the granule’s shape, the bulk density, the powder’s flowability, and more. In other words, it is now easier than ever to be able to narrow down the best milling technology available for a particular product, one that will ultimately help to make improved and more robust tablets. But the benefits of the SLS – Scalable Lab SystemTM go far beyond the test results in the lab, as what good are successful lab trials if they cannot be easily and reliably scaled-up and transferred to a production environment. If the technology used for small sample sizes does not translate into predictable production-scale equipment, then all the tests need to be repeated and re-validated. This does not sound like a good strategy. Scalability – that is, getting the same particle characteristics in a production run as those obtained with small product samples, just at larger volumes – is something that needs to be the basis of lab equipment to make the investment really count. How does the SLS address this? Two words: Smart DetectTM. How does it work? Simply put, as each head is placed and coupled with the base drive platform, the Smart DetectTM feature automatically pre-sets the RPM range of the impeller or rotor inside the milling chamber, thus ensuring the tip velocities of the rotating element are the same as larger production machines. Consistent tip velocities ensure that as the particles are processed in the lab-sized module, they are subject to the same influences as their larger production-sized counterparts. For example, when milling takes place, keeping tip speeds constant – regardless of model size – means the powder will be exposed to the same level of impact, shearing, compression and/or cutting size reduction forces. The operator cannot err and enter a speed into the SLS that cannot be duplicated with a production machine. That is smart. Of course, other parameters also need to be maintained and transferred from lab to production to ensure scalability, such as screen-hole diameters and hole-type profiles (round holes, grater/rasp holes, etc.), impeller/rotor leading edge configuration and feeding methodologies. Just like the number of healthier foods and more natural choices are continually increasing to help improve our overall well-being; technology is also constantly advancing, making the user’s experience, a more efficient and productive one – particularly at the lab-scale where frequent technology changes are the norm. “Until purchasing the L1A *with the interchangeable U5 head lab+ ….we had a lot of waste and not much control. It is a very easy piece of equipment to operate, adjust, clean, and exchange heads. We are already trying to get approvals to purchase another unit” (Zoetis, USA). Reducing the time required to scale-up milling results from lab to production, reducing the number of individual single-use machines, providing a wider range of size reduction technologies without increasing the overall footprint or breaking the bank in the process, are all at the core of what makes the SLS – Scalable Lab SystemTMso attractive. “I have used mills for 20 years and getting more integrated equipment just makes sense” (Dr. Robertson). If we draw one last similarity with our grocery buying metaphor, then as we head towards the check-out, we should be looking at our shopping cart and weighing the pros/cons of choosing healthier options and consider what is best for the long-term. Ultimately, whether our decisions are related to our health or to the equipment we invest in for better lab-scale performance…making the right choice… just makes sense.