01 July 2018

Planning a Pharmacy Cleanroom

Create a list of desired elements for the new or renovated cleanroom and assign them to one of two categories: the essentials (elements that are critical to the basic functioning of the cleanroom complex, mandated by regulation, or central to the efficient functioning of the operation), or ancillary items (components that would be nice to have but are not crucial to ensure functionality or compliance).

Basic Cleanroom Structure. Determine whether the cleanroom will be modular construction or traditional drywall construction (ie, stick built). Then, evaluate the available options and select the fit and finishes of the cleanroom, including ceilings, floors, walls, doors, and light fixtures.

Safety Systems. Choose flush-mounted sprinkler heads, emergency lights, eye wash fixtures, and any other life-safety elements as mandated by local code.

Secondary Engineering Controls (SECs). To control your cleanroom complex within acceptable limits and approved tolerances for temperature, humidity, and airflow, a properly sized and maintained HVAC and HEPA air filtration system is vital.

Primary Engineering Controls (PECs). Select effective laminar flow cabinets, workbenches, biological safety cabinets, and/or isolator units for compounding.

In addition, consider taking an open architecture approach to cleanroom builds, which can include integrated, unidirectional vertical laminar flow (UVLF).

Ancillary elements in a cleanroom build or renovation project may include new and innovative technologies:

Telepharmacy systems with camera or video capture systems
Automated continuous environmental monitoring systems
Automated compounding devices or other robotics

Other non-essential, but possibly valuable additions to your cleanroom may include:

Powered door openers
Cleanroom seating
Large view windows
Pass-through cabinets, pass-through refrigerators, or full-height pass-throughs for transferring drugs, supplies, and other materials into and out of the cleanroom

A qualified cleanroom consultant can assist in evaluating the myriad choices available and can provide insight into what has worked—and more importantly, what has not worked—in installations at similar facilities. In addition to providing guidance on technical and regulatory issues, an experienced consultant can advocate on your behalf with both the cleanroom contractor and your organization’s administration for elements that are required to ensure the long-term success of your operation. Even if your team already includes an architect and general contractor, a consultant with pharmacy experience in cleanroom workflow and design, budget processes, and assembly of these complex rooms can aid in ensuring a smooth process.