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ENABLE INJECTIONS PHASE II CASE STUDY

BACKGROUND

Based in Evendale, Ohio, Enable Injections develops medical devices that are disposable and allow patients to self-administer injectable prescription therapeutics wherever they are. Before manufacturing its devices on a global scale, Enable Injections enlisted the help of Western Environmental in 2016. In this initial project, we designed, installed, and certified a modular, 3,000 sq. ft., ISO 8 cleanroom, which delivered temperature and humidity control that allowed Enable Injections to multiply its manufacturing capability and continue refining its FDA-approved devices.

Pleased with our ability to complete cleanroom and metrology lab design and construction in a timely manner and under budget, Enable Injections didn’t think twice about requesting our services again, this time for a cleanroom expansion project. The company tasked Western Environmental with revamping and extending its cleanroom space so it could continue to expand its processes.

PROJECT CHALLENGE

After several years of using the initial cleanroom and furthering developing operations, this expansion project needed to address several challenges that Enable Injections brought to our attention. For one, the cleanroom allowed the company to increase its staff and equipment, but this came with greatly altered heat load and utilities distribution. Hoping to further increase its production capabilities, the expansion would be the same size as the existing cleanroom, though it would bring similar challenges associated with increased manufacturing equipment and personnel.

Further presenting obstacles was the issue of maintaining the existing cleanroom while constructing the new one, which was built immediately adjacent to it. Therefore, without compromising the existing cleanroom, the expansion had to accomplish the following:

  • Provide doorways to connect the two cleanrooms

  • Allow common access to the new, larger gowning room

  • Expand the compressed air, nitrogen, and electrical service equipment into the existing cleanroom

RESULTS

Meeting these challenges and exceeding Enable Injections’ expectations, Western Environmental completed this cleanroom expansion project on time and budget. The expansion introduced a brand new, 3.000 sq. ft., ISO 8 cleanroom that quadrupled Enable Injections’ manufacturing capacity.

Positioned adjacent to the initial cleanroom we designed and constructed in 2016, the new space required a significantly larger electric service to be brought into the main building to accommodate the increase in equipment. The ideal layout was also achieved without disturbing the current cleanroom or ongoing operations. Now, Enable Injections can easily access both cleanrooms through interconnected doorways, as well as the new gowning room in the expanded space. The company is also benefitting from the expansion of the compressed air, nitrogen, and electrical service equipment into the existing cleanroom, saving crucial space in the new cleanroom.

DESIGN PARAMETERS

– Temperature: 68°F

– Stability: +/- 5°F

– Relative Humidity: 45 %RH

– Stability: +/- 15% RH

– Cleanliness: ISO 8 (Class 100,000)

– Enclosure Size: 3,000 Sq. Ft.

ISO Cleanroom turnkey