Keeping Cleanrooms Clean: Best Practices and Equipment

As the name implies, cleanrooms must be clean. In the food and pharmaceutical industries, it’s imperative that cleanrooms are up to code to not only avoid fines, but to keep consumers safe.

Fortunately, facility managers of these critical environments have many tools and equipment options at their disposal to remain in compliance, ensure product integrity, and improve their bottom lines. One good starting point is to review the many government and industry organization guidebooks available.

Gain Clean Room Compliance by Using the Food Safety Plan Builder

Referenced in the FSMA Final Rule for Preventative Controls for Human Food, the Food Safety Plan Builder is a new tool designed to provide food facility owners and operators with plans tailored to their facilities that meet the requirements of 21 CFR Part 117 (specifically subparts C and G).

This guide offers assistance in navigating standards related to GMPs and prerequisite programs, hazard analysis and preventative controls determination, process preventative controls, and sanitation preventative controls. Although this tool doesn’t automatically ensure a facility’s food safety plan meets FDA requirements, it does is outline ways to gain compliance via its requirements.

Comparing Food Safety Best Practices Internationally

Another asset for food industry organizations – particularly multinationals – is the Global Food Safety Initiative (GFSI). While not a certification program, this umbrella organization provides equivalency between food management certification programs. For example, it outlines comparable audit schemes between:

• British Retail Consortium (BRC) Global Standards
• FSSC22000
• Safe Quality Food Institute (SQFI)
• Global Aquaculture Alliance
• International Feature Standards (IFS)

Having a plan is the first step in creating a clean environment. Using the right equipment to keep it clean is the next step. There are a number of technologies used to ensure cleanrooms can be cleaned often and easily to allow operations to proceed without delay.

Prevent Contamination with High Speed, Lightweight Doors

High-speed, lightweight doors are used not only to prevent cross-contamination, but also to help maintain correct room pressures, air circulation rates and optimal operating efficiency.

Doors compliant with cGMP and the FDA standards are essential, with key considerations being ease of cleaning and durability. In all cases, these doors must be able to stand up to repeated cleaning with chemical solvents and have a smooth, hard, non-porous surface resistant to microbial and fungal growth. Doors should also have a tapered surface and edges that essentially eliminate harborage of dust or other contaminants and possess no sharp angles to minimize harborage of microbes. Additionally, they should:

• be corrosion-resistant (which is often a problem with older door systems);
• use stainless steel side frames and shrouds; and
• incorporate a lubrication-free design, since lubricants can attract particulates.

It is also advisable to avoid doors with exposed fasteners and coils, as they will take longer to clean and could harbor contaminants.

Clean Room Best Practices Recommend Control Over Air Pressure

The best door systems allow for wireless interlocking of air locks. A door capable of at least 50 Pa in pressure differential is needed to maintain a tight seal and minimize air leakage. Given the requirement to maintain pressure differentials, doors that seal tightly and cycle quickly are essential for pharmaceutical processing. A properly designed door helps ensure the facility’s makeup fans can satisfy the required amount of makeup air needed to maintain pressure.

Fabric Ductwork Helps Disperse Air Without Turbulation

Fabric ducts provide targeted, precise, and efficient air dispersion throughout the length of their run. In contrast, standard metal ductwork, using localized diffusers spaced many feet apart, can create hot and cold spots along the length of the system. Fabric ducts use various methods to achieve this uniformity, including: air porous fabrics, linear vents, nozzles, and orifices. Providing versatility similar to that of curtain walls, fabric ducts are easier than their metal counterparts to customize and reconfigure as needs change.

Some fabric ducts are designed specifically for clean environments. Distributing air through their permeable fabric, these products use a uniform and low-velocity airflow to minimize the possibility of air turbulence. Turbulent air can lead to cross contamination in cleanroom environments that measure for airborne particles. It also can negatively affect research in laboratory environments. Fabric air dispersion devices can effectively work with fume hoods or other airflow-sensitive equipment, as well.

Moveable, Washable Walls Segment Clean Room Environments

While anti-microbial walls have always been important in segmenting environments, there is a growing use of flexible, industrial fabric walls for applications subject to wash-down protocols. They are quicker, easier, and less expensive to install than traditionally constructed walls. These non-permanent walls can be moved or reconfigured to satisfy future changes in the process or floor plan, as well.

Fabric walls are particularly prevalent in the food industry, where they play key roles in maintaining sanitary conditions and are increasingly being used for applications related to blending, mixing, powder ingredient, raw ingredient, or other production operations.

While the USDA and FDA do not specify cleanroom regulations in the food industry, they do provide guidelines based on Hazard Analysis & Critical Control Points (HACCP) best practices. One of the most common uses for industrial fabric walls in the food industry is for the isolation of production lines so they can be cleaned while other lines nearby continue to run at peak efficiency. Not only do these flexible fabric walls allow plant engineers to easily enclose areas and contain overspray from cleaning, but they can also help reduce potential for cross-contamination during production processes.

Your Next Steps to Implementing Your Clean Room Plan

Cleanroom technologies are constantly evolving. It’s critical to stay up to date on those advancements – from high-speed doors to industrial fabric curtain walls – as well as new industry best practices to make sure your facility’s cleanroom is in compliance and maintaining product integrity for consumers.

This blog was developed from the Essential Guide: Cleanrooms and Clean Areas. For additional information on these topics and a full list of sources, click here.