For safeguarding critical environments, one of the most crucial features for a door system is cleanability. This holds true especially in the pharmaceutical manufacturing arena where even a particle 200 times smaller than the human hair can cause major disaster leading to costly downtime or recall.
When Atlanta-based Mikart decided to modernize their liquid and oral dose manufacturing facilities, the door systems were part of the revitalization process.
A provider in pharmaceutical formulation development, contract manufacturing and packaging services, Mikart project engineers were looking to replace their original door system with a more technologically advanced system designed for exceptional cleanability.
“Taking product from development to commercial production calls for seamless delivery,” Tom Holliday, Mikart engineering manager, said. “We cannot afford to waste time or money in production by constantly worrying about keeping doors clean.”
Holliday also cited the need for a conventional door system to provide good seal between production rooms and the corridor, preventing dust and dirt collection.
Mikart project engineers teamed with ASI Technologies, Milwaukee, to implement the CleanSeal® door system into the 140,000-square-foot operation, which includes new state-of-the-art formulation development and QC laboratories along with a pilot scale manufacturing operation.
CleanSeal Sales Manager Ritchie Longoria worked with Mikart project engineers in developing a flexibile, plausible solution to their requirements.
“Old-style cleanroom and lab areas are usually outfitted with hollow metal or aluminum doors, but in an area that is truly pharmaceutical, where it’s critical to keep the doors extremely clean, hollow metal and aluminum doors don’t necessarily fit these needs. Eventually, they start to flake, deteriorate and sometimes virtually dissolve after being exposed to toxic and severe cleansers,” Longoria said. “Mikart now has a renovated hallway that blends into a new built-out section completed to help Mikart gain strides in what level of client they can service, as well as to bring the current areas into a new level of cleanliness.”Mikart project engineers wanted and needed an economical solution to the new area that provided a door system with cleanability while meeting FDA standards. Flexibility was another significant specification in the door system design.
“It was important that retrofitting wouldn’t add another expense to the door system. They also needed a versatile locking system to meet DEA requirements for processing controlled substances and still allow for Life Safety access and egress,” Longoria said. Even though locks weren’t ordered originally, ASI was able to accommodate the Mikart team. Because of the versatility of the door systems, locks were added and programmed to suit the operation.
“The doors we had before presented cleaning challenges. They weren’t structurally designed for cleaning because they contained a number of hard-to-reach nooks and crannies,” Holliday said. “We’re very satisfied with the CleanSeal design because of its lightweight fiberglass panel for easy cleaning and corrosion-resistant hardware.”
The power models also keep particulates out with its continuous perimeter seal.
Mikart’s commitment to meet and exceed current FDA and cGMP standards is evident throughout their operations. All production rooms are designed with totally independent HEPA-filtered HVAC systems. And now their choice of cleanroom components, such as the CleanSeal door systems, reflects their commitment to quality as well.
“With more than 28 years of outsource experience, we’re well equipped to take pharmaceutical discoveries from pilot scale through full commercial production. This process is even more efficient with the help of a reliable, durable, cleanable door system,” Holliday said. “We’ve made a wise investment in Mikart’s future.”