There are few parts of the manufacturing facility as complicated to manage as the cleanroom. The requirements to meet cleanroom standards are stringent and every aspect of the space — from airflow and what workers are wearing to which direction the doors swing — has to be carefully considered.
The stakes are also high, as manufacturers use cleanroom environments to handle delicate materials that could be easily ruined by contamination. And the rise of personalized medicines is putting more manufacturing work into the cleanroom space.
“The increased demand for oncological and immunosuppressant therapies in the pharmaceutical market paired with the ‘biotech boom’ has brought unique manufacturing challenges to the industry,” says Michael Avraam, the global product manager at ChargePoint Technology for PharmaSafe products. “On the one side, the market is experiencing a surge in drug manufacturing using high potency active pharmaceutical ingredients and on the other, the requirements for sterile and aseptic processing have reached an all-time high.”
With more time spent in sterile environments, manufacturers are looking for ways to make life in the cleanroom easier, while further reducing risks of contamination. With those goals in mind, vendors are continuing to rise to the challenge with innovative products.
Clean High Fives
It’s a simple change to a standard cleanroom product. But the innovation behind STERIS’ new aerosol alcohol dispenser has still made a big impact for operators.
Traditionally, when workers in a cleanroom want to sterilize their hands they have to locate and fumble with a can of aerosol spray before returning to work. Now, STERIS’ new dispenser allows operators to decontaminate their hands using a foot pedal or an elbow/forearm actuator.
“It’s not complicated at all, but was designed with that cleanroom environment in mind,” says Michael Gietl, the senior product manager of Process Cleaners at STERIS. “It offers robust cleanroom features including stainless steel, and can reduce some of the variability in hand sanitization procedures.”
Gietl says the new dispenser shows how a simple update — such as the hands-free design — can go a long way in improving efficiency for manufacturers.
Air it Out
Airflow is one of the most critical considerations of designing a cleanroom space. The higher the grade of cleanroom, the more air flow is needed to keep the air free from contaminants.
Although much of the equipment in a cleanroom is stainless steel, which can be easier to decontaminate, DuctSox Corporation, a Rite-Hite subsidiary, has innovated an air duct and dispersion system that instead uses fabric.
Designed with critical environments in mind, the company says that unlike metal, the fabric DuctSox system diffuses air evenly across the entire length of the ductwork system while offering 360 degrees of draft-free air dispersion.
“One of the major challenges when designing airflow for critical facilities is achieving the correct amount of air at a low enough velocity to not interfere with air sensitive equipment such as fume hoods,” the company says.
DuctSox says the fabric system is able to enhance sanitation in critical environments because it reduces the threat of condensation commonly generated by metal diffusers. And because the fabric system can be removed and laundered, it is easier to clean and more cost effective than traditional metal duct work.
Of course, there are plenty of high-tech solutions aiding cleanroom manufacturing as well. Just like other parts of the facility, automation is becoming an increasingly prevalent tool for improving operations.
ChargePoint Technology recently launched its VERIFI smart-monitoring hub — a wireless technology that fits directly onto a split butterfly valve (SBV) installation and provides operators with vital usage data while also generating an easily accessible audit trail. Avraam says that targeting the SBV allows companies to more efficiently and flexibly protect workers and products from contamination exposure.
“By recording how many times the valve has been used and monitoring its temperature, VERIFI generates data that allows operators, and health and safety teams to proactively manage the maintenance of their containment solution with very little human intervention,” Avraam says.
The Complete Solution
Because the cost of square footage in a cleanroom is high, manufacturers have also been increasingly looking for ways to save space in sterile environments.
“There is a desire for fewer walls and more connectivity, but the necessity for protecting the integrity of the cleanroom itself remains,” Peter Levison, executive director of business development at Pall Biotech, says. “Though it can be challenging to achieve these goals, the growing adoption, and development of single-use technologies has enabled the introduction of closed, bioburden free cleanrooms that require less infrastructure.”
Recently, Pall Biotech, which provides a full suite of single-use systems, announced a new partnership with G-Con Manufacturers, who provide self-contained, ready-to-use manufacturing PODS. Under the deal, G-Con PODS will be customized with Pall bioprocessing equipment, including automation and utility supplies. The new partnership will allow the companies to offer a sort of one-stop shopping solution by providing a complete, scalable facility that is modular and easy to clean. The companies say the turnkey solutions are available for continuous bioprocessing and viral vector production.