E-Book | January 16, 2020

Reducing Risks With Single-Sourced Modular Cleanrooms

The Modular Approach

Life sciences industries require highly controlled environments for drug research development and manufacturing.

Cleanrooms — a concept developed in 1960 and refined since — maintain the strict airflow, temperature, humidity, cleanliness, pressurization, and containment standards needed to innovate in this highly regulated environment.

An expertly designed cleanroom is crucial not only for drug and biologic development but also for patient safety. One small issue could lead to contamination that renders a life-saving drug unusable, potentially costing the drug manufacturer millions of dollars.

That same drug, if injected into patients, could prove fatal. One only has to look at New England Compounding Center, whose pharmacist improperly sterilized three lots of preservative-free methylprednisolone acetate. His disregard for standard operating procedures and patient safety caused a fungal meningitis outbreak that infected 753 people, 64 of which died.

Although cleanrooms used to manufacture sterile drug products have to meet International Standards Organization (ISO) and Food and Drug Administration current good manufacturing practice (cGMP) standards, modular cleanroom installations offer benefits that go beyond standard methods of traditional “stick-built” construction. When built using a turnkey approach, modular cleanrooms dramatically reduce risk while offering greater efficiency, cost savings and compliance.

Here at AES we get asked this question all the time. We created a stickbuilt vs modular playbook with the help of Patrick Poisson, Executive VP of Technical Operations for United Therapeutics, and Brian Weed, VP of Sales for Controlled Contamination Services.

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