Overview
When Atlanta-based Mikart decided to modernize their liquid and oral dose manufacturing facilities, door systems were integral to the revitalization process. As a provider in pharmaceutical formulation and development, contract manufacturing and packaging services, Mikart wanted to replace their existing doors with a complete and integrated system of doors that would offer exceptional seal and cleanability.
Challenges
“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 door system that could provide a good seal between production rooms and the corridor to prevent the infiltration of dust and dirt.
Mikart engineers chose ASI Doors for the project and worked with them to integrate the correct door system into their newly remodeled 140,000 square foot facility. The updated facility included a new formulation and development area, quality control laboratories, and a pilot scale manufacturing operation.
Solution
ASI Doors’ team worked with Mikart engineers to develop a flexible, plausible solution for their new requirements.
Older cleanroom and lab areas are usually outfitted with hollow metal or aluminum doors, but in an area where it’s critical to keep the doors extremely clean, hollow metal and aluminum doors start to flake, deteriorate, and sometimes even disintegrate after being exposed to harsh cleansers.
Mikart’s renovated hallway needed to blend into a planned new build section that would meet more stringent standards and allow them to expand the types of clients and projects they could accommodate. Existing areas would be required to be brought up to the new cleanliness standards.
Mikart project engineers needed an economical door solution that could meet stricter industry requirements yet, provide the flexibility necessary to accommodate a variety of operations.
During the project development it was recognized that the doors were going to require a versatile locking system to meet DEA requirements for controlled substances processing while still allowing for Life Safety access and egress. 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 ASI Doors design because of its light-weight fiberglass panel for easy cleaning and corrosion-resistant hardware. The power models also keep particulates out with their continuous perimeter seal.”
Mikart’s commitment to meet and exceed FDA and current GMP standards is evident throughout their newly renovated facility. All production rooms are designed with totally independent Hepa-filtered, HVAC systems. And now, their choice of quality cleanroom components, such as ASI Doors door systems, reflects their commitment to maintaining those standards over time.
“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.”