Cleanroom Designs – 15 things to consider when designing a pharmaceutical clean room

Cleanroom Design Considerations | 15 things to consider when building a clean room

When designing or building a pharmaceutical clean room, every single component, piece of equipment, environmental control, surface, process and safety measure must be thoughtfully engineered — or you’ll risk failing to meet EU GMP or GMP requirements.

Clean room designs are a crucial part of your ability to meet GMP and EU GMP requirements when producing pharmaceuticals for domestic markets or exportation. The time to get this right is in your earliest stages of cleanroom design and engineering. If your clean room isn’t fully compliant, efficient and economical to maintain, your manufacturing processes could readily fall into serious problems. If it fails an audit by a regulatory Auditor (for example, FDA or TGA auditors), your pharmaceutical facility could get shut down overnight.  As anyone who has built a clean room knows all too well, mistakes during engineering, design and construction can get costly.  Read more to discover 15 things to consider when designing a clean room for pharmaceutical manufacturing, including for antibiotics, reagents and injectables, complementary medicines, vitamin supplements and/or herbal medicines such as medicinal cannabis or CBD extraction cleanroom design(s).

Considerations for Clean Room Design(s) | Pharmaceutical Manufacturing Cleanroom Engineering

To prevent a Joe-like disaster, make sure you consider all the following points when designing or building a clean room for health care products.

1. Stakeholder consultations are a crucial part of clean room designs

Has everyone who has a stake in the clean room’s operation been consulted? This includes:

  • Maintenance – ask them what will need to be maintained and how it will be done.
  • IT – ask them to think of the worst-case needs for the future and build those in from the start
  • Production – ask them what their needs are. What space will they need and what are the process requirements? What about cleaning?
  • QC – are any microbiological sampling points required? How much media will they need to bring in at one time?

2. Clean room design | Clean room grade

  • Have you specified the correct grade of clean room so that it’s not over-specified for the processes that will be housed in it (and not under specified so that it can’t be used for any future processes).
  • This is critical – consult everyone and get it right.

3. Protrusions into the clean room

What is protruding into the room – disrupting any surface. Eliminate as many as you can. Common offenders include:

  • Lights
  • Smoke detectors (they won’t work anyway, get rid of them)
  • Power points

4. HVAC ducts | clean room design requirements

  • Check that they will be smooth and without internal insulation or if they are insulated, they should be lined with Melinex® or Mylar®
  • Consider other sources of fibres or particles that might be introduced into your clean room and eliminate as many as possible

5. Clean room equipment

  • Check that the clean room will accommodate the size of the equipment that will go in there, including any required clearances.

6. Power

  • Check existing electricity infrastructure (substation/ switchboard/ mains/ circuit breakers) installed on site. Can it support the anticipated load requirements of the clean room?
  • Plan for power failures – will production continue? If so, consider a diesel generator set (for emergency power) and/or UPS (critical power)
  • Distribution boards should be located outside the clean room
  • Is there spare space and capacity for future equipment upgrade/ plant expansion?
  • Know where/ how the equipment is to be located in the clean room, then coordinate the location of the power points/ MCC
  • Power outlets should be recessed on the wall (slim design type), no sharp edges. Make sure no exposed services/ cabling will appear in the cleanroom

7. Clean room lighting | Clean room engineering

  • How will it be serviced? Can this be done from outside the room or will you need to shut down the room to replace a light fitting? Use sealed IP65 lighting types, with top maintenance access. LED lighting types are preferable.
  • Ensure there is adequate lighting levels for the required tasks, i.e. 400 lux, as recommended in AS/NZS 1680. Also, ensure lighting uniformity. Do any specific tasks that need higher lighting levels? eg. in precision tooling, inspection etc.
  • Lighting control modules should be located outside the clean room.
  • Provide emergency and exit lighting to current building code requirements.

8. Containment

  • If the clean room is being used for potent materials, e.g. cytotoxic drugs, then how will you manage containment requirements for items that need to be removed or replaced in the clean room?
  • For example, how will you manage containment when replacing, or servicing, equipment components?

9. Change rooms (clean room gowning areas)

  • Are the change rooms adjacent to the clean rooms big enough to accommodate everyone who might be in there at the same time?
  • What are the safety measures and door lock timings?
  • Is there a risk of wasting staff time and/or of your personnel not following gowning procedures due to problems with the change room layout or size?

10. Dust explosions

  • If your facility is a dusty environment, have you considered how to prevent or handle a dust explosion in the clean room?
  • Dust explosions are a risk of clean rooms and must be taken into account.

11. Viewing windows in clean rooms

  • Have you got enough viewing windows into the clean room so that staff can be supervised while they are in there without a supervisor having to gown up?
  • Consider double glazing if you have a window between two sterile areas – this will allow the glass panes to be flush with the wall (no sill), making cleaning easier.

12. HVAC filters

  • Related to clean room grade, have the correct size HVAC filters been specified? Too big and they’ll drive up energy costs. Too small and they won’t do the job they are intended for.

13. Clean room surfaces

  • Are all surface finishes i.e. walls and flooring, compatible with your cleaning agents and disinfectants?
  • Are the surfaces engineered and installed properly to avoid contamination-friendly crevices?
  • Are the materials durable and able to withstand the loads and sterilisation procedures and chemicals they will be subjected to?

14. Waste flow

  • Have all waste flows been considered, including used garments. This is especially important in facilities that handle potent materials but is often overlooked.

15. Clean room security

  • Consider installing CCTV inside the clean room for remote monitoring to minimise personnel entry.
  • Sealed dome-type CCTV housings should be installed with top maintenance access.
  • Provide electronic access control to the clean room e.g. swipe cards and door interlocks.
  • Security panels should be located outside clean room.

This list of considerations for pharmaceutical cleanroom designs is not inclusive, and other clean room design requirements (and risks) apply.

For more on pharmaceutical plant and pharmaceutical manufacturing engineering, including cleanroom designs and renovations, or to get started on a reconstruction project for your pharmaceutical cleanroom, contact PharmOut’s top cleanroom engineering consultants.

Page last updated July 15, 2019. CM