Therapeutic Dose: Greening the Pharma Lab

Reducing environmental impact may not have been vendors’ primary goal, but it has been a welcome result, allowing dramatic cost savings.

By Emil Ciurczak, Contribuing Editor

I enjoyed Pittcon 2011, last month in Atlanta, more than any in recent years. As reported in the press, the show’s tone was upbeat this year, as the global economy slowly comes off life support. One theme, possibly unintended, was “better, cheaper, and faster.” Already mentioned was UPLC, which, while touted for its speed, also saves massive amounts of solvent and, peripherally, electricity (not to mention lab heating vacuum and air conditioning costs, since analysts can go home on time).

I was enamored by some of the “little” things I saw there. (Videos of my top five technology finds are posted on PharmaQbD.com.) For instance, I could hold one electron spin resonance (ESR) “toy” in the palm of my hand. The ESR I used in grad school was the size of a Volkswagen minibus. In addition, the miniaturized model runs on 9-12 volts instead of requiring the power of a small municipality. Miniaturization wasn’t the intent of the development, but it was a welcome result.

The ion mobility instrument that attracted me does neat analyses, of course, but so much more is saved, when compared with HPLC or LC—the taking samples to the lab, sample preparation, actual injection and elution of solvents, calculations and reporting, maintenance and parts.

Performing an HPLC analysis typically takes a day or so. To do a good job, a number of samples must be taken from across the blender/mixer/granulator or whatever type of equipment is involved. If we assume a dozen samples per piece of equipment, we are talking liters of solvents to buy and dispose of, hours of running time, and a couple of days of downtime for the equipment. Compare that with on-the-spot analyses with minimal solvent and almost no down time . . . how green is that?

And the number of small, handheld spectrometers that so many companies are offering is remarkable: NIR, Raman, and even MIR instruments were all on display in Atlanta. Thanks to these instruments, inspectors, regulators, and law-enforcement personnel are much closer to taking the lab to the field than ever before, without having to ship samples to a nearby lab or across the ocean. Reflecting the trend to mobile equipment, Thermo Fisher Scientific has dedicated an entire group to handheld devices.

Moving from the field to the production plant environment, handhelds also enable significant savings.  Let’s start with raw material qualification. Since the 1980’s, when EMA suggested that 100% of all containers of all incoming materials be tested for ID and purity, we have been using, for instance, NIR for this purpose. In the early days, we used lab-based instruments, sent a tech to the warehouse, had him or her open each container, sample each one, label the containers (bags or bottles), then carry them back to the lab, place them on the instrument, scan and record the results. No wonder so few companies bought into the container-wise testing of raw materials: the time involved was prohibitive. Of course, the “square root plus one” approach, most common in the industry, allows 89 of every 100 containers to pass untested. A handheld unit speeds up testing, eliminates the need for sampling, labeling, and transporting samples; that’s both convenient and “green.” In addition, the devices encourage more sampling, which can lead to safer/better products.

Overall, more and more types of instruments are becoming available in smaller and smaller versions: in addition to the ones previously mentioned, there are thermal analyzers, gas chromatographs, viscometers and many more. Most measuring devices are not just getting smaller than before; they also are adding Wi-Fi options. With on-board power supplies (making them explosion-proof and saving materials and power over conventional explosion-proof cabinets), wireless options, and small size, these new tools are capable of being placed nearly anywhere along a process line.

In fact, all the tools used for process analytical technology (PAT) tend to save time and power, although almost as an afterthought. And, naturally, there are naysayers motivated by investments (both financial and emotional) in the status quo. But either by design or happy accident, we are creeping towards greening our plants—not as fast as kudzu grows, but at least faster than the sequoia.

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