Cleanseal Door System Completes Contract Manufacturer's Facility Update

June 30, 2015

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Challenge

When safeguarding cGMP & ISO environments, one of the most important considerations for choosing a door system is cleanability.

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.

“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 Cleanseal Door Systems for the project and worked with the Cleanseal team to integrate ‘just the right door system’ into their newly remodeled 140,000 square foot facility. The updated facility included a new, formulation and development area, QC laboratories and a
pilot scale manufacturing operation.

Solution

Cleanseal’s sales and project team members worked with Mikart engineers to develop a flexible, plausible solution for their new requirements.

Old-style 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 don’t necessarily fit those needs. Eventually, they start to flake, deteriorate and sometimes virtually dissolve after being exposed to harsh cleansers.

Mikart’s renovated hallway needed to blend into a new build-out section that would meet more stringent standards and allow them to expand the types of clients and projects they could accommodate. Existing areas would also require a whole new level of cleanliness.

In an industry where even a particle 200 times smaller than the human hair can cause a costly recall, controlling infiltration and the cleanability of every surface are key concerns.

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.

It was important to Mikart that any necessary retrofitting would not mean additional cost. During the project, however, it was recognized that the doors were going to require a versatile locking system to meet DEA requirements for processing controlled substances while still allowing for Life Safety access and egress.

Even though the locks weren’t part of the original specifications, 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 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 the Cleanseal 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.”