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Pharmaceutical Environmental Control Unit: Where Process Control Drives the Outcome

Pharmaceutical Environmental Control Unit: Where Process Control Drives the Outcome

A pharmaceutical company that specializes in chemical process technology solutions came to CleanroomSystems® for help maintaining a cleanroom environment for one of their compound research and development (R&D) units. More specifically, they were looking for a customized pharmaceutical environmental control unit that would control the temperature, relative humidity, pressure and cleanliness of the space and process.

The Challenge

This client had a small process area within an R&D cleanroom, where potentially explosive chemicals and powders were being mixed. Since chemical properties change in the face of environmental fluctuations, controlling the process determines the outcomes. This solution would need to preserve the integrity of their process to ensure accurate results.

The cleanroom could not experience more than a 1.8℉ (1℃) shift in temperature in any one-hour period and no more than 5% relative humidity over a one-hour period. Moreover, the solution would need to adhere to Class 1 Div 2 parameters.

The Solution

CleanroomSystems partnered with this pharmaceutical company to design, build and test an advanced, custom HEPAir® environmental control unit (ECU) configured with once-thru air to maintain conditions within the process area.

The unit was cart-mounted outside of the space and ducted in, with the C1D2 controller located inside the active space. The inlet air came from an existing controlled environment of 68℉ to 86℉ (20℃ to 30℃) with 10-50 percent relative humidity. While preconditioned inlet air is always preferred, the unit was designed to facilitate environmental control even without it.

To ensure accuracy in controlling the process-room temperature and humidity, CleanroomSystems designed the system to include a duct mounted combination temperature/dew point sensor with an accuracy of ± .9℉ (.5℃) temperature and ± .9℉ (.5℃) dew point. The sensor was mounted in the end of a short section of stainless-steel ductwork attached to the unit and provided a convenient location for the client’s process duct connection.

The custom environmental control unit also included both a 2.5kW electric heater for on-demand heating (depending upon ambient conditions) and a custom humidifier to add moisture as needed.

The final stainless-steel system was securely mounted to a portable cart and included Poron® microcellular closed-cell insulation, urethane sealants and closed-cell gaskets, as well as non-shedding, non-off gassing componentry. As with all CleanroomSystems, this unit was designed to meet or exceed UL standards and was also designed to be reused for future R&D initiatives.

The Result

  • The environmental control system included cooling, heating, humidification, pre-filtration and HEPA filtration.
  • The unit measured 23.5” X 47.5” X 14.25”
  • Design output conditions of 68°F (20℃) ±0.36°F (±0°C) and 46-53°F (8-12°C) ±1.9°F (1.0℃) dewpoint were met.
  • 150 CFM fixed airflow capacity
  • Maximum 0.15” external static pressure
  • Integral air-cooled condenser with nominal 1 ton R-134A reciprocating compressor
  • Standard propeller blow-thru fan configuration
  • ISO Class 6 filtration
  • The solution was designed, manufactured and tested at the CleanroomSystems
  • Meets all UL certification requirements

If you’re ready for a custom solution from CleanroomSystems, like this custom pharmaceutical environmental control unit, contact us by submitting a Project Inquiry or by calling 1-800-835-3268 today.

If you would like to see case studies for other industries, view our general case studies page. If you are interested in seeing more case studies for the semiconductor industry, look at the items below. We also have whitepapers available covering the aerospace industry, the semiconductor industry, and our Micro Environments product line. The whitepaper page can be found here.

Just Ask Our Clients

"I'm really impressed with the how the unit is responding to the test parameters, and the recovery times are exceptionally impressive. Your attention to detail and expertise is very evident with how the PECS is performing during this final test phase."

Ed Duben - Mission Management, United Launch Alliance