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People often come to us for a budgetary price for their cleanroom project without much information about their needs. A cleanroom is an investment and a real asset in a company’s strategy and needs to be well thought through. Many decisions must be taken when building a cleanroom, and these will affect the cleanroom performance, ergonomics and cost. The following 5 questions are, in our opinion the first ones to ask when initiating a cleanroom project.

Cleanrooms are used in practically every industry where small particles can adversely affect the manufacturing process. They vary in size and complexity, and are used extensively in industries such as semiconductor manufacturing, pharmaceuticals, biotech, medical device and life sciences, as well as critical process manufacturing common in aerospace, optics, military and Department of Energy.

A cleanroom is any given contained space where provisions are made to reduce particulate contamination and control other environmental parameters such as temperature, humidity and pressure. The key component is the High Efficiency Particulate Air (HEPA) filter that is used to trap particles that are 0.3 micron and larger in size. All of the air delivered to a cleanroom passes through HEPA filters, and in some cases where stringent cleanliness performance is necessary, Ultra Low Particulate Air (ULPA) filters are used.

Personnel selected to work in cleanrooms undergo extensive training in contamination control theory. They enter and exit the cleanroom through airlocks, air showers and/or gowning rooms, and they must wear special clothing designed to trap contaminants that are naturally generated by skin and the body.

Depending on the room classification or function, personnel gowning may be as limited as lab coats and hairnets, or as extensive as fully enveloped in multiple layered bunny suits with self contained breathing apparatus.

Cleanroom clothing is used to prevent substances from being released off the wearer’s body and contaminating the environment. The cleanroom clothing itself must not release particles or fibers to prevent contamination of the environment by personnel. This type of personnel contamination can degrade product performance in the semiconductor and pharmaceutical industries and it can cause cross-infection between medical staff and patients in the healthcare industry for example.

Cleanroom garments include boots, shoes, aprons, beard covers, bouffant caps, coveralls, face masks, frocks/lab coats, gowns, glove and finger cots, hairnets, hoods, sleeves and shoe covers. The type of cleanroom garments used should reflect the cleanroom and product specifications. Low-level cleanrooms may only require special shoes having completely smooth soles that do not track in dust or dirt. However, shoe bottoms must not create slipping hazards since safety always takes precedence. A cleanroom suit is usually required for entering a cleanroom. Class 10,000 cleanrooms may use simple smocks, head covers, and booties. For Class 10 cleanrooms, careful gown wearing procedures with a zipped cover all, boots, gloves and complete respirator enclosure are required.

Cleanroom Air Flow Principles
Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles. Laminar, or unidirectional, air flow systems direct filtered air downward in a constant stream. Laminar air flow systems are typically employed across 100% of the ceiling to maintain constant, unidirectional flow. Laminar flow criteria is generally stated in portable work stations (LF hoods), and is mandated in ISO-1 through ISO-4 classified cleanrooms.

Proper cleanroom design encompasses the entire air distribution system, including provisions for adequate, downstream air returns. In vertical flow rooms, this means the use of low wall air returns around the perimeter of the zone. In horizontal flow applications, it requires the use of air returns at the downstream boundary of the process. The use of ceiling mounted air returns is contradictory to proper cleanroom system design.

Cleanroom Classifications
Cleanrooms are classified by how clean the air is. In Federal Standard 209 (A to D) of the USA, the number of particles equal to and greater than 0.5mm is measured in one cubic foot of air, and this count is used to classify the cleanroom. This metric nomenclature is also accepted in the most recent 209E version of the Standard. Federal Standard 209E is used domestically. The newer standard is TC 209 from the International Standards Organization. Both standards classify a cleanroom by the number of particles found in the laboratory's air. The cleanroom classification standards FS 209E and ISO 14644-1 require specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area. In the UK, British Standard 5295 is used to classify cleanrooms. This standard is about to be superseded by BS EN ISO 14644-1.

Cleanrooms are classified according to the number and size of particles permitted per volume of air. Large numbers like "class 100" or "class 1000" refer to FED_STD-209E, and denote the number of particles of size 0.5 mm or larger permitted per cubic foot of air. The standard also allows interpolation, so it is possible to describe e.g. "class 2000."

Small numbers refer to ISO 14644-1 standards, which specify the decimal logarithm of the number of particles 0.1 µm or larger permitted per cubic metre of air. So, for example, an ISO class 5 cleanroom has at most 105 = 100,000 particles per m³.

Both FS 209E and ISO 14644-1 assume log-log relationships between particle size and particle concentration. For that reason, there is no such thing as zero particle concentration. Ordinary room air is approximately class 1,000,000 or ISO 9.

The HVAC system is at the heart of the cleanroom. Although many clients are unenthusiastic when broaching the subject, the HVAC system should not be overlooked given its central role. HVAC is actually the most complex and important system of a cleanroom facility as the HVAC is responsible for controlling air cleanliness, temperature, humidity, and pressure. This article aims at simplifying the cleanroom HVAC concept to facilitate conversations with your cleanroom supplier for your next project.

If you’re working on putting together a design for your cleanroom, you’ve likely noticed that there isn’t a ton of helpful information out there. That’s because up until recently, most buyers just hired a contractor they felt they could trust, and left it at that. But if you’re here, it’s likely because you’re a part of the newer generation of buyer: the savvy, researching buyer who wants all the information before you even head to a cleanroom manufacturing pro.

Well, we’re here to help you out as best we can. We know it can be tough to find the info you’re looking for when it comes to cleanroom components, so we put together this blog to help you figure out your options for cleanroom walls. First things first, what are the most basic components you need for a successful cleanroom wall that upholds your application’s standards?

When it comes to cleanroom walls, you’re really looking for two things: smooth, dust-free surfaces. But finding the type of surface that’s perfect for your operation is a bit easier said than done. To determine what wall material type is best for you, there are a couple of considerations to keep in mind:

If you have a cleanroom or laboratory space, chances are it cost your company a great deal of money to construct and get into working order. Because of that investment, you want to get the most mileage out of your cleanroom. But you shouldn’t put off updating or redesigning your cleanroom, especially when it’s integrity and functionality are crucial to your processes and operations. Here’s when you know it’s time for a new cleanroom:

Cleanroom equipment is expensive, but that’s because it’s high functioning, specialized equipment for an extremely important and sensitive job: maintaining your cleanroom’s integrity and required classification standards. But like all equipment, it breaks down, wears out, and slows down with time. So how do you know when to replace it?

Food microbiology labs have a variety of special considerations due to the sensitive nature of the work and its importance. Not only do they need dedicated laboratory space for testing, but the controlled environment of a cleanroom is also critical. Here are some things to consider when designing a cleanroom for food microbiology applications.

Obviously, your cleanroom’s construction and air filtration system are critical factors in keeping your cleanroom contamination-free, but so is what people wear in the cleanroom. People and fabrics are major sources of contaminants, and it’s crucial your control those sources with proper attire. Here’s what (and what not) to wear in a cleanroom:

Elevated floor system, which is also termed as access floor system, is a raised structural floor that is placed on a reinforced concrete slab. The elevated floor system consists of a several panels, as shown in Figure-1, which are installed on vertical adjustable pedestals as it can be noticed in Figure-2. The pedestals are fixed on the concrete slab using suitable means for instance adhesives or mechanical fixings.

There are many reasons to design or retro-fit a work space with raised access flooring (RAF). RAF systems create value from the bottom up by overcoming the restrictions of traditional flooring and creating a work space that is highly reconfigurable, efficient, productive, safe and organized. Because every space is different and every design is guided by specific requirements, we decided to compose a list of 5 benefits that raised floor systems can deliver to just about any application.

In most cases, a data center’s under floor is also its air plenum.  Not cleaning beneath a raised floor can result in contaminants being drawn into sensitive computer equipment, which can cause overheating and shorten their life.

To maximize your investment in your Raised Floor, regular maintenance is a must. All raised floors require preventative maintenance to insure safe operating conditions for equipment and personnel. Listed below are the requirements for proper raised access floor maintenance and care:

It's worse than cleaning out the garage. It's cramped, stuff is piled and tangled everywhere, and what's worse, a lot of it is alive! And like a bunch of snakes, you're afraid that if you touch something, it will bite -- only this "bite" might be an outage that could cost you your job.

It seems like in a cleanroom, it’s almost impossible to over think every move and decision you make. Sometimes people make mistakes they couldn’t have anticipated until they happen. Here are 5 common dangers that not everyone is cognizant of when working in a cleanroom.

If you have a cleanroom, you need to take care of your HVAC. Here are 5 checkpoints to keep you running efficiently and economically.

Static control in packaging has been around for centuries. In its earliest years, it was used to prevent the electrostatic discharge (ESD) ignition of gunpowder stores. Today, there are many kinds of devices, parts, and pieces manufactured in cleanrooms that are vulnerable to ESD. Since basic motion and activity can create a static charge, it’s important that these items are packaged in ESD protective materials. Here are a few options.

While the advanced air filtration systems in modern cleanroom HVACs trap most dust particles, cross contamination from dust is still a concern. Dense dust, which has high water content, and metal-containing dust can easily find its way into cleanrooms via things like the corrosion of faucets and plumbing or technician clothing. A careful protocol is necessary to remove these dust particles and avoid spreading contaminates during cleaning.

Cleanrooms are incredibly complex. Without the right amount of planning when building one, you can encounter one time and money-sucking challenge after another. You can’t just think about your needs now, but also in the future. Situations like expansion, repairs, and upgrades can be an enormous headache if you’re not set up for it when the time comes for change. When you’re building a cleanroom, here are 5 characteristics you want to ensure it has to avoid costly, time-consuming obstacles.

You have decided you’re going to renovate or expand your pharmaceutical manufacturing facility. You have developed a conceptual plan and now, during the detailed design phase, you will need to make a critical decision about the quality of the facility of which you will be operating. One of the most important decisions you will make on this project revolves around the materials of construction - specifically, the built environment surrounding your process.

Deciding whether your cleanroom should be modular instead of drywall is not the only decision a project team has to make when considering a cleanroom. In most cases, the choice of panels is not as clear cut as once was the norm.

What to decide? Say for instance, you have decided to go with a modular system. Now you have to deal with the wide selection of materials available with different suppliersor within the assortment of a single supplier.

The selection of one or another of the mentioned materials may lead to the need of using supporting or enclosing material. “Soft” or easy to disaggregate material, such as rockwool, may require an enclosing structure to provide the panel with the necessary mechanical stability or to prevent the gravity falling effect of the disaggregation over time. Clean area SOP requirements may require the enclosure of any insulating material within the panel. The choice of the material used for the supporting/ enclosing structure may be dictated by the consistency with the material used for skin support. It will not make sense to use a higher quality material, such as aluminum, if the supporting skin is galvanized steel.

There are many sophisticated tools for measuring the conditions inside a cleanroom facility. These tools, their precision readings, and the monitoring they allow, are essential to keeping the equipment and conditions up to the required standards for cleanroom operation.

Clean rooms are highly sophisticated buildings that fulfill crucial functions for highly sensitive processes. Clean room design and construction is now a special segment of the building industry and accounts for the specification and installation of an ever increasing amount of interior surface finish material. A clean room is a specialized enclosure that establishes an environmentally controlled space where airborne particles, microbes, temperature, humidity, airflow, and other elements are carefully regulated. Clean rooms are no longer used just in the aerospace industry. Today clean rooms are built wherever contamination control is important: pharmaceutical and medical technology labs and production areas; semiconductor, computer, and communication system assembly and testing facilities; optical, biotechnology, food and drink processing plants.

The most dreaded words a flooring contractor can say to a client are “you have a moisture problem.” In laymen’s terms a moisture problem means that water vapor is passing from the ground below the building through the concrete subflooring. These vapors combine with the chemistry of concrete and over time will destroy and undermine the bond between flooring materials and concrete. Unfortunately, this type of moisture is not visible in the formof a puddle of water on the floor.

MANY FACILITY PLANNERS, concerned about contamination or potential scheduling delays, once dismissed the thought of installing electrostatic discharge (ESD) safe tile in operational clean spaces. Rather than risk tearing their buildings apart and losing valuable production time, many companies chose alternative methods to ESD flooring to be ANSI/ESD S20.20-1999 compliant. ESD industry control practices may include the combination of wrist straps, grounding cords, floor mats and “Faraday Cage” material handling protocols. Until recently, installing a new ESD floor most often included the difficult taskof removing the old floor first.

Let us start with the reasons why a functioning cleanroom facility manager might want or need to replace a floor. Regardless of the issues involved, one does not replace an existing floor unless it is absolutely necessary. Floors are only replaced when the existing flooring, usually a seamless epoxy or tile, becomes incompatible with ongoing needs. In a cleanroom or cleanmanufacturing facility, there are four main reasons why this happens:

In any of the four replacement scenarios above, before any serious plans are made or dismissed, it makes sense to start with a broad evaluation of various ESD flooring alternatives. Any thoughtful evaluation should begin with an investigation involving process compatibility, and then an examination of the risks/rewards of installing a new floor based on successfully dealing with obstacles such as shutdowns, equipment movement, loss of production, contamination, odor containment and other considerations. At this point it is usually advisable to create a decision matrix or at least give a cursory glance at ESD flooring solutions. Of course most of the options will be quickly dismissed based on contamination control parameters or unsatisfactory electrical properties (point to point resistance, and resistance to a groundable point).Below is a reasonable list of possible flooring materials:

Stringent standards and safety protocols are put in place to ensure that products manufactured and inspected in cleanrooms will not pose any hazards to the end user.

There is no one-size-fits-all answer for determining the classification level of cleanrooms — they come in different shapes and sizes, they’re used for many different applications, and their cleanliness needs are quite varied. Therefore, it’s important to know what classification level you’re dealing with, and how best to tailor your practices, apparel, products, and equipment to meet these specific needs.

Pharma Tech Industries, a pharmaceutical contract manufacturer and packager of powder products, recently introduced a highspeed bottling line for the production of Rx, OTC, and nutritional ingestible products at its facility in Union, Mo. The bottling line is housed in a new, specially-built ISO 8 Class 100,000 controlled environment designed for non-sterile Rx pharmaceutical-grade oral products. All equipment is of modular, quick-change design to enable minimal downtime between campaigns.

Controlled Environments spoke with Tee Noland, Chairman and CEO of Pharma Tech Industries, about this cleanroom facility addition.

A clean room design requires careful consideration of its intended use, permissible particle concentration, location, manufacturing process and of course cost. The design and specification of a clean room require close coordination between the many departments impacted by it and the design team. Certain products, such as pharmaceuticals and medical devices, must be built in a sealed and sterile environment to avoid contamination and ruin.

1. Understand your process before you engage in building a cleanroom.
2. Gather a team from all disciplines — manufacturing, quality control, compliance, purchasing, facilities — who will understand the expectations of both you and your customers. Prepare for expansion now ... don’t wait until later.
3. Prepare the scope of work required.
4. Make sure you are working with a qualified engineering team and builder.
5. Get a certifier involved as a member of your team.
6. Archive all documentation throughout the pre-design, design, and manufacturing processes. Documentation from close out is imperative for moving forward. Expect and demand great close out documents.
7. Negotiate fair progress payments.
8. Check the financials of the contractor and their subs, to make sure they can carry the project costs.

Contamination control is being used by more and more industries where the highest level of cleanliness and hygiene is of vital importance. These are the things that need to be considered when building an effective contamination control room.

The professional cleaning industry is changing more and evolving faster today than at any other time in its history. While this is happening, the majority of cleaning contractors are so busy with their day-to-day business operations, they may not see even more changes coming right around the corner. 

Ron Segura, president of Segura Associates, one of the industry's leading cleaning consultants working with both cleaning contractors and facility managers, says to deal with these changes, we must take steps now to "future-proof" our businesses. 

Today, when most of us purchase a new electronic device, just about whatever it is, the first thing we do is take it out of the box, plug it in, and start it going. No reading manuals; no watching instruction videos; if a quick start-up guide is included, maybe we’ll take a look at it.

The problem with this plug-and-play mentality is that we can pay a high price for it. We typically do not reference the manual until something goes wrong. Very often at that point, we find out the problem we are now facing could have been avoided with proper equipment maintenance practices — what started out as a minor equipment issue has now become a major repair cost.

When it comes to cleaning equipment, the high price that managers of controlled environments may pay can be very high indeed. This is why they must stress that their cleaning professionals, whether in-house or contracted, properly maintain their cleaning tools. For instance, if airborne dust is released from a poorly maintained vacuum cleaner, it can damage work areas and experiments. Poorly maintained floor machines can do the same as well as possibly damage the floor’s finish or the floor itself. The point is this: plug-and-play is great, and a time saver; but disregard plug-and-maintain when it comes to cleaning equipment at your own peril.

To help cleaning professionals and administrators avoid these pitfalls, below are some common equipment maintenance issues often included in the owner’s manual that get lost in our plug-and-play world.

Problem: Maintaining air quality is essential to meeting criteria for cleanroom standards, and air quality cannot be measured without also measuring the air flow within the cleanroom environment. Specialized tools are required to gather the readings that represent the air flow through the ventilation systems, as well as a solid understanding of those systems.

Solution: There are several types of ventilation system setups commonly used in cleanrooms — each of which are put in place to remove contaminants from the environment and help meet and maintain cleanroom standards. It is necessary to check the air flow of those ventilation systems periodically, as many factors can affect the movement of air over time, such as buildups in the ducts, leaks, aging and worn fans and pumps, etc. Here we identify the most common types of ventilation systems used in cleanrooms and the most appropriate instrumentation to monitor the airflow throughout those systems.

TIP 1: Cleanrooms are designed with Specific Industrial Applications in Mind
As a rule, your project’s industrial category will determine which cleanroom design requirements are in effect. Here are four of the most common categories:

• Healthcare product manufacturing (includes pharmaceuticals and medical devices)
• Electronic semiconductor manufacturing
• Food manufacturing
• Biological and chemical research laboratories

 
Each of the above has their own unique design requirements.

Cleanroom designs can be further segregated into two groups: those that work with hazardous materials and those that do not.

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).

When renovating a cleanroom, or creating one from non-cleanroom space, understanding the details — of the site, building, planned research, and equipment — is essential. A cleanroom can be used for many things: semiconductor fabrication, microelectronics assembly, aeronautical assembly and testing, pharmaceutical research or manufacturing, or geochemistry. One size definitely does not fit all.

The cleanroom market has grown tremendously in the past 50 years due to increased regulations and the rise of safety concerns. Furthermore, a growing number of companies now choose modular over conventional construction. Here are some facts that you should take into account when considering a cleanroom supplier.

The turnkey approach to design building a cleanroom has been moving toward the forefront of cleanroom design and construction for many reasons — one of the most important being schedule. Design build lends itself to fast track construction in such a way that a high quality product can be delivered, as well as help reduce a customer’s time to market. With the critical nature of hitting a window with certain products, the faster the project completes the better.

Clients often come to me specifically requesting an “ISO 7 cleanroom” or an “ISO 8 cleanroom.” What they often fail to realize is that the ISO class does not define the layout of the cleanroom. It only defines the cleanliness level that needs to be met. In fact, the ISO classification actually corresponds to a specification of how clean the cleanroom must be. The ISO 14464-1 standard doesn’t say how to design the cleanroom, it only specifies the maximum quantity of air particles allowed.

Whether the goal is high yields or regulatory compliance, controlled environments are integral to pharmaceutical manufacturing processes. Air showers are vital to maintaining the clean environment; they help protect operations from the constant threat of air particulate contamination. Medical device, bio-tech, and pharmaceutical industries require contaminant-free environments and use air showers as part of their operations.

A facility transformation begins long before the A&E and other service providers are invited to the table. Typically, a business model is used to map out and project demand for specific products, estimate product production rates, and time lines for expected product introduction and product ramp-up to match the expected demand. Several factors are considered to determine where the facility should be located: proximity to the customer pool, availability of qualified on-site resources and availability of existing infrastructure, market conditions, and regulatory climate.

The building housing this expansion was comprised of offices, labs, manufacturing and support spaces, with a total of over 220,000 square feet of space. Distinctive air-handling zones existed for the offices, the labs and the manufacturing areas. Offices were served by several packaged single-zone systems. The labs and the manufacturing areas used air handlers utilizing chilled water and hot water coils.

In terms of cleanliness, the manufacturing space was design to meet ISO 7 classification in at rest condition. Entry and exit points were specified at air changes per hour that met ISO 7 requirements for this non-sterile drug product. The air change rate in the gowning rooms was set higher to promote particle capture at entry and exit points. The corridors were clean but not classified or CNC. A transition zone occurred inside the gowning room to take into account the movement between the CNC space and the ISO 7 area, as depicted in the image below. This transitional zone was physically demarked by a step-over bench that separated the clean side from the dirty side. Gowning at the entry point was downed at a level that was prescribed by the user as part of the administrative protocols to minimize both introduction of particles and cross contamination of the API from external sources. For this facility, people entering the manufacturing area from the CNC corridor downed a second layer of gowning (the first layer was downed at the entrance to the CNC space). People moving from one production suite to the next needed to follow gowning protocols at each entry and exit point.

A strategy was developed for the movement of materials and people throughout the cleanroom. Eventually, a layout of the facility was agreed upon. It is important to understand that the development of the layout was a critical factor in that the design work cannot proceed fully without a “frozen” layout. More often than not, there is a level of hesitation from the parties involved — typically on the owner side — with endorsing a final layout. It is safe to assume that even with the best intentions, changes will occur after the layout is frozen and endorsed, and design professionals can only hope for a properly managed change process. Layout development is a process that does not follow a straight line. It is seldom, if ever, a black and white type of solution. Instead, this is the part of the design that takes a great deal of effort to achieve consensus. The process is interactive, and that involves multiple steps. Teams gathered to discuss what was required (the action), and a space program is preliminary developed in response (the reaction). Unless all the stakeholders are present, which is rarely the case, this can be a time-consuming process.

At the onset of the project, the goals and objectives for the project were set. Energy reduction was one of them. And the owner was pursuing this goal aggressively, not just for this project but for the rest of the existing facility as part of a separate but parallel project. Efficiency targets were provided by the client to the design team that needed to be met or exceeded. It was refreshing that this client was willing to support this effort by not value engineering out energy saving features to save money and encouraging and providing a simplified path to justification and approval of approaches that reduced use and conserved energy. This client viewed energy savings beyond simple payback analysis. Some of the salient energy savings are listed below.

Whether it’s because of advances in science and technology, growing regulation, or increased competition, companies and organizations throughout the world continue to face greater needs for controlled environments in their facilities. Oftentimes these needs arise very quickly and require solutions that can be implemented in a very timely manner. Such situations have spurred growth and innovation in the development of new modular cleanroom systems. Today’s facility operators can now choose from numerous modular systems to match their particular needs.