Pitfalls in Aging Facilities

BioPharm International® spoke with Kenneth LaRiviere, head of Engineering at Andelyn Biosciences, about how manufacturing biopharmaceuticals in an aging facility might cause regulatory and production problems. He also discusses what companies can do to be sure they are meeting good manufacturing practice standards.

Companies must be sure the facility they are using to manufacture biopharmaceuticals is capable of meeting environmental requirements, such as particulates, graded space, and air changes, according to LaRiviere. “Differential pressure is another critical parameter for operations in bioprocessing facilities,” he continues. “You must be able to maintain your pressure cascades as necessary to ensure cleanability and a clean environment for your operations. Laminarity and unidirectional flow are critical if you are working in a Grade A space and other things like temperature and humidity [are also important].”

LaRiviere states that particulates can be an issue in older facilities, and filters are, therefore, required. “Rooms have HEPA filters in them. So, generally speaking, the HEPA filters, for the most part, don't fail very often, but as facilities age, the frames, the housings that the HEPA filters are in can develop cracks and leaks,” says LaRiviere. “So that is just something that happens with age, and something facilities would need to maintain. And older fans have difficulty moving the required amount of air.”

The ability to clean a facility is imperative, according to LaRiviere, and older facilities may not be built for easy cleanliness the way newer buildings are in their design. “Cleaning is critically important. If you can't clean your facility, you really can't operate.”

Click the above video to watch the full interview.