Top 5 Questions to Ask Yourself When Designing a Cleanroom

Considering the countless designs and operating regulations, specifying the right clean room for your application is not a simple 1-2-3 process. But as with other capital purchases, a checklist of critical questions can help guarantee a decision that meets your expectations. Here&#;s what our clean room specialists first evaluate when designing a controlled environment:

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How will my clean room be used?

The processes taking place in a cleanroom determine functional characteristics. For instance, static sensitivity or chemical processing dictate specific types of construction materials. Perhaps your needs can be met with a softwall cleanroom that features full-view plastic panels, or maybe you need an all-steel modular cleanroom for ultimate cleanliness. The number of personnel, their frequency of access, approved garbing protocol and necessary application equipment have a significant influence on cleanroom design as well.

How much space is available?

Working space can be a significantly limiting factor when designing your clean room. Available ceiling height, for example, will influence ventilation, air conditioning costs, and the ease of replacing air filters. Additionally, some operations require gowning before workers enter the clean room; space constraints may dictate either an internal or external gowning room.  An air shower may even be needed, depending on how clean the environment needs to be. For larger projects, engineering considerations become more apparent. Seismic analysis can assess which changes may need to be made in your design to ensure an overall stable operation.

Finally, very large modular rooms, with spans greater than 20 feet, will generally require internal support pillars or external bracing that entails a contractor and formal permitting process. Smaller rooms generally do not require these provisions and are therefore much faster and economical to bring online.

Which cleanliness rating does my application require?

Although each clean room operation typically involves its own unique protocol, the International Standards Organization (ISO) has set global classifications as a standard benchmark for cleanliness levels. ISO requirements specify the number of particles per cubic meter of air, which is maintained by a certain airflow velocity and air changes per hour. These standards let you calculate the quantity and location of FFUs within the clean room (Tables 1 and 2). The more stringent the cleanliness requirement, the greater the number of fan/filter units and the higher the initial and ongoing operational expense. After determining how many FFUs you&#;ll need, it&#;s important to space them evenly across the ceiling without clustering them together. Uneven air flow will disrupt laminar airflow uniformity, causing unwanted turbulence.

This commonly used equation helps decide the number of FFUs needed for your controlled environment:

No. of FFUs = (Air Changes/Hour ÷60) x (Cubic ft. in room÷ 650)

*650 represents the average cubic feet per minute (CFM) output of a loaded FFU at medium speed. Round up fractions to avoid under-performance

  

*Tables 1 and 2 based on IEST recommendations

What type of air pressure is needed?

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The main variable that determines the type of cleanroom air pressure is whether the sample is to be protected from the surrounding environment, requiring positive pressure isolation, or whether personnel and the surrounding environment are to be protected from a harmful sample, requiring negative pressure containment.  A positive pressure cleanroom maintains a uniform laminar flow (Figure 1), in which air is forced through filters located in the ceiling, and exits vents at the base of cleanroom walls. A negative pressure cleanroom removes hazardous chemicals or powders either by exhausting room air through the ceiling (Figure 2) or along the base of the wall (Figure 3).

Air flow and pressure are important to consider because they influence the physical space and energy consumption of your cleanroom. You may be subject to building permits or regulations, especially if the cleanroom design alters the structure of your facility or risks releasing harmful fumes into the environment.

 

What other design considerations are integral to my specific application?

Just as assembly lines have a particular order for tasks, cleanroom protocol will influence positioning of doors, outlets, pass-throughs and other utilities. Swing doors or pass throughs, for instance, can be obstructed by equipment, so do you move the equipment, or relocate the door? If you anticipate moving large equipment in and out of the cleanroom, you may want to consider a removable wall. Some applications are best accommodated with roll-up or slide doors or oversized cart pass-throughs.

Likewise, some models of light fixtures can interrupt airflow uniformity. Consider installing tear-drop fluorescent fixtures or LED strip lights on the ceiling grid in-between FFUs to maintain laminar air flow. Your facility&#;s overall energy consumption and costs can benefit from these design options.

It may be necessary to assemble your modular room close to an existing lab, or designated manufacturing/testing areas. Since the cleanroom has its own power module, it only needs a ceiling-drop electrical connection; running wiring from a central power system is not difficult. However, if the cleanroom contains equipment requiring a source of water, such as hand-washing stations, plumbing is a consideration. PVC pipes can also be run overhead and dropped down to the room location, but drainage (perhaps to the existing plumbing system) should be planned prior to erecting the room.

Conclusion

After closely examining the major factors that influence how your cleanroom will be used, you may be faced with even more pressing questions. You can find helpful information from our Modular Cleanroom Design & Configurations. Terra has product specialists and engineers who can answer your application-specific questions. Give us a call or chat with us online today!

Clean room 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 . 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.

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