ENABLE INJECTIONS CASE STUDY
Enable Injections
LOCATION: Evendale, OH
PROJECT: Turn-Key 3,000 Sq. Ft ISO 8 Modular Cleanroom
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PROJECT CHALLENGE
Enable Injections laid out several cleanroom parameters that Western Environmental’s final product to meet. The company specified that its new cleanroom had to be 3,000 square feet, turnkey, and ISO 8 certified. Further, it also requested that the cleanroom be able to maintain environmental factors like temperature stability, low- and high-end humidity set points, and cascading room pressures. Finally, the new cleanroom had to conform to the FDA’s standards to ensure the compliance of its manufacturing and distributing operations.
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RESULTS
To achieve an effective, timely solution, we built the cleanroom’s shell enclosure out of tightly sealed, insulated modular wall panels. We also incorporated a suspended and gasketed ceiling system, thereby creating a plenum space above. To round out our design, we also installed several fan filter units to create a reliable inflow of clean air.
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For stress-free HVAC operation, Western Environmental implemented a programmable logic computer to maintain precise environmental conditions in the cleanroom at all times. What’s more, this environmental condition is certified, monitored, and continuously documented, keeping Enable Injections ahead of their assembly curve and the FDA’s stringent specifications.
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We completed Enable Injection’s ambitious expansion project ahead of schedule and below their initially budgeted cost. It was a team effort furthered by several parties, as other developments and construction occurred at the same time that Western Environmental designed and built the cleanroom.
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DESIGN PARAMETERS
– Temperature: 68°F
– Stability: +/- 3°F
– Relative Humidity: 45%RH
– Stability: +15%/-15%
– Cleanliness: ISO 8
– Enclosure Size: 3,000 square feet
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BACKGROUND
Enable Injections is a start-up company that produces disposable, self-injection medical devices. Its unique products allow patients to safely inject themselves with prescription medications at home, at work, and everywhere between. To refine their device before introducing it to the global market, Enable Injections moved into a 41,000-square-foot building in Evendale, Ohio in 2015. However, they still needed a 3,000-square-foot, turnkey modular cleanroom with ISO 8 certification.
That’s where Western Environmental came in. To complete this medical cleanroom construction project, we drew from our expertise in cleanroom design, construction, and certification to meet Enable Injection’s specifications in a timely, cost-effective manner.
