A rapid-deploy, ultra-pure cleanroom manufacturing solution with potentially disruptive impact to the industry
A very informative article was recently published in Pharmaceutical Online comparing two of the most common air filters in use in pharmaceutical manufacturing and lab environments: HEPA and ULPA. The article, entitled “HEPA Versus ULPA: Which Filter Should Your Biosafety Cabinet Use?” goes into detail describing not only the airflow management in biosafety cabinets (BSC), but the air filtration used, the many standards applied to the industry guiding performance minimums for the filters, and the types of filters most commonly found.
HEPA (High Efficiency Particulate Air) is quite prevalent in the industry. Depending on the type of HEPA filter used and standards supported by the type, HEPA filters are designed to remove 99.99% of hazardous particles ranging in size from 0.1 to 0.3 microns. ULPA (Ultra-Low Particulate Air), depending on the type used and standards involved, is designed to remove 99.995-99.999% of particles ranging in size from 0.1 to 0.3 microns.
There is some variation to these numbers (which you can read about in more detail in the article) but the specifications show ULPA having slightly higher performance and thus, more effective filtration, if at a certain cost. HEPA filters are more cost effective than ULPA filters, do not restrict airflow as much and have a longer lifespan than ULPA filters—but are not quite as effective.
For many applications, particularly in small, contained environments such as BSCs, this approach to filtration is the standard.
But talk with professionals who oversee cell therapy or cell culture in biotech and pharmaceuticals and you’ll hear them talking about an emerging opportunity: a combination of more advanced air purification that performs well-above the specifications of HEPA or ULPA alone, matched with modular cleanroom solutions that allow for comparatively quick and cost-effective installation at new—and existing—facilities.
This unique combination provides an opportunity to accelerate the process of bringing new clinical and commercial manufacturing facilities online, with high-performance production and testing environments that in-turn reduce the overall time-to-market of new pharma products. These two elements are forecasted to significantly reduce cost and delivery time–allowing facilities to come online within a fraction of the current standard time, and with fully-operational cleanroom lab facilities on-premise outperforming traditional HEPA and ULPA filtration methods alone.
LifeAire Systems—with origins in developing comprehensive air remediation solutions for ultra-sensitive cleanroom environments such as in vitro fertilization (IVF) labs—has partnered with mobile cleanroom solution provider, G-Con Manufacturing to deliver a pharma/biotech-friendly bolt-on “POD” for life science applications offering a patented, multi-stage air filtration solution that produces an environment free of 99.99% biological and chemical contaminants that could adversely affect production and lab testing.
When higher capacity and in-turn higher throughput cause manufacturing issues such as deviation in batches rendering them unusable, production managers seek solutions that help decrease the number of variables they must consider that are impacting their manufacturing process. The ambient air in the production environment is both dynamic and pervasive and therefore a significant threat that facilities need to control in their clinical and commercial manufacturing facilities. The LifeAire solution was engineered over a period of 15 years to compensate for the shortcomings of individualized remediation techniques targeting airborne pathogens to achieve a level of purity that effectively allows companies to eliminate the variable of air from their concerns.
While the LifeAire solutions are available as stand-alone installations in manufacturing facilities and labs, when incorporated into G-Con’s modular cleanroom PODs, the LifeAire System delivers this level of purity in a rapid-deploy solution that helps eliminate air as a concern while accelerating the manufacturing timeline.
The advantages of a purpose built multi-stage filtration solution—like the LifeAire System which combines HEPA filtration with other remediation techniques—also extends into other aspects of the production business environment. In addition to this enhanced level of air purification providing protection of living cell/tissue culture, transfection, and gene and cell therapy processing environments, LifeAire’s solution is uniquely designed to efficiently maximize remediation on a single-pass, thus reducing the required supply air volume, related energy use and HVAC operating costs.
For life science companies exploring what could be the next big disruption in manufacturing and speed-to-market, we suggest you consider looking at alternatives that extend beyond the front line HEPA and ULPA solutions and deliver air purity in a modular, business-friendly package that supports accelerated new market strategies.
For technical performance details on the LifeAire System, please contact LifeAire by calling 484-224-3042 or emailing [email protected].