Spotlight on Cleanroom Technology

Interphex Connector, April 2015 

The global cleanroom technology market was valued at $2.7 billion in 2013 and is expected to grow at a CAGR of 5.5% and reach $3.67 billion in 2019, according Research and Markets.

The market research firm points to rising regulatory concerns regarding product quality and worker safety in the healthcare industry; an upsurge in the development of new biologics, which is increasing the demand for sterilized pharmaceutical formulations; and the rising used of cleanrooms in the medical device industry as main growth drivers. Two of the main challenges for manufacturers of cleanroom technology, however, are the growing demand for customized designs and the high cost of installation.

Research and Markets breaks down the global healthcare cleanroom technology market into two segments: equipment and consumables. Equipment includes fan filter units (FFU), heating, ventilation, and air conditions (HVAC) systems, laminar airflow systems and biosafety cabinets, HEPA filters, and air diffusers and showers. Consumables include safety (apparel, gloves, etc.) and cleaning (vacuum systems, wipes, disinfectants, etc.). Cleanrooms are also segmented by the type of construction, which includes standard/drywall cleanrooms, hardwall cleanrooms, softwall cleanrooms, and terminal boxes/pass through cabinets.

During the forecast period, gloves, wipes, and hardwall cleanrooms will continue to drive and dominate the healthcare cleanroom market. There is particular interest in modular cleanrooms, which offer several advantages, including flexibility in construction and cost effectiveness. While North America accounted for the largest share of the cleanroom technology market in 2013 and will continue to dominate the market in 2019, Research and Markets predicts that the greatest growth will occur in India, China, Brazil, and other emerging markets where the pharmaceutical and medical device industries are rapidly expanding.

The healthy growth rate experienced in the cleanroom market is reflected in the number of exhibitors at the upcoming Interphex 2015 show, which will take place April 21-23 at the Javits Center in New York City, offering cleanroom-related technology.

PortaFab is introducing a new lightweight, flexible framed cleanroom wall system as an alternative to traditional cleanroom wall systems that is lower-cost without sacrificing quality or functionality, according to the company. The new system features vertical and horizontal members that are easily connected to each other and provides airtight seals around equipment for minimum loss of room pressurization. The company is also launching a new modular cleanroom strut walls that provide a cost-effective solution for bay- and chase-style cleanrooms. Incorporation of a standard strut-style metal framing into the wall system eliminates the need to frame out cleanrooms while still utilizing standard strut connectors for piping, conduit, and other utilities. The system also incorporates a ½”-thick aluminum honeycomb panel and lighter weight aluminum extrusions that cost less and are easier to transport and assemble, according to the company.

G-CON Manufacturing will be highlighting its autonomous cleanroom PODs technology.  The prefabricated, self-contained, autonomous cleanroom PODs come in a range of designs and sizes for laboratory environments to personalized medicine and production process platforms, and can be customized as well. According to the company, the PODs offer a solution that reduces budget and facility constraints because they are flexible, rapidly deployed, scalable, mobile due to integrated air bearings, repurposable, and simple to maintain, replacing the need for sophisticated and expansive purpose-built facilities.  The PODs can be used for monoclonal antibody, vaccine, or recombinant protein development or production, and they can either be dedicated to a process step or deployed as a small volume total process containment solution, involving either glove boxes or isolators within the POD. The Green POD is available for plant-based research, development, and manufacturing. G-CON was recently selected to build an ISO Class 5 POD for Instituto Butantan, a biomedical research center in Sao Paolo, Brazil that will be used in the clinical production of recombinant BCG, a product intended to be an improved treatment for bladder cancer. The company also received the CE Mark approval for its PODs, demonstrating the conformity of PODs to European standards.

The companies exhibiting cleanroom technologies at Interphex 2015 are too numerous to mention, but a representative sample includes, in addition to PortaFab and G-CON Manufacturing, AdvanceTEC, TEK Stainless Piping Products, Cleanseal Door Systems, The David Round Company (cleanroom material handling equipment), Howorth Air Technology (ultra-clean ventilation systems), and Palbam Class (cabinets and disposable dispensers). 


Guy Tiene

Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.