Why You Need a Cleanroom, Not Just a Lab

Why You Need a Cleanroom, Not Just a Lab

When you’re in manufacturing, whether you’re dealing with pharmaceuticals, food, or even industrial products, quality is always a critical concern. When quality control matters, you have to test products, and most of that testing likely occurs in a lab. Some products will even need to be manufactured in a laboratory setting. But is your lab the right environment to ensure quality in your manufacturing processes? If it’s just a lab in name only, and not a true cleanroom, it might not be.

What’s the difference between a lab and a cleanroom?

A laboratory is a space dedicated to scientific research, experiments, and testing, as well as the manufacture of certain types of products. There is nothing in this definition that requires the laboratory environment to be controlled in any way. While a pharmaceutical manufacturer might have a highly controlled laboratory environment, a local high school might also have a lab, wherein students conduct experiments under no environmental controls.

A cleanroom is a controlled environment, specifically one that controls the level of contamination from particles, along with other factors such as temperature, humidity, static, etc. Controlling all of these variables protects your processes and products from contamination or conditions that could compromise the integrity of those products and processes.

Cleanrooms are required to meet specific standards as to the number of particles acceptable within the space, and to meet that standard, the cleanroom is regularly tested. Equipment and systems are put in place to maintain the cleanroom environment, including air filter systems and air flow systems, as well as procedures for entering and using the space, from special chambers called air showers that blow contaminants off of personnel before they enter the cleanroom to requiring lab coats or gowns for personnel working in the cleanroom.

Why do you need a cleanroom instead of just a lab?

If you’re not controlling your lab environment, there’s really no point in having one. It’s not going to ensure product quality, integrity, and safety—and those things are all necessary for a sound manufacturing process. For certain industries, like semiconductor manufacturing, pharmaceutical manufacturing, and aerospace and defense manufacturing (just to name a few of the many industries that use cleanrooms) cleanrooms are either required by law or are enforced as an industry standard. For example, automotive manufacturing cleanrooms are generally required to meet ISO Class 7 or 8 standards in order to meet the supplier requirements of the OEMs they work with and to ensure the quality of their products.

Is it time to upgrade your lab to a cleanroom? Get in touch with the cleanroom experts at Angstrom Technology.

 

How are Cleanrooms Validated?

How are Cleanrooms Validated?

Validation is an important process for any cleanroom. It serves to ensure that the cleanroom is properly designed for its intended ISO classification and that all of the components (facility, environment, equipment) meet regulatory requirements and other defined standards. So what’s the cleanroom validation process?

Most often, cleanrooms are validated by third-party validation agencies. This entails a thorough inspection and several tests, whereafter the cleanroom is certified to a specific class indicating its level of control, usually to an ISO14544-1 class.

Validation has several phases, beginning with design qualification, and ending in final certification.  Some of the tests performed in these phases include airflow volume and velocity tests, HEPA/ULPA filter leak testing, air movement visualization (smoke testing), room pressurization, room recovery, airborne particle count tests, relative humidity, temperature, and other testing conditions.

Certification consists of three main phases. Installation qualification is also referred to as Phase 1 or “As built” testing. Testing is performed with all services connected and working, but no materials, production equipment, or employees present, proving that the equipment is correctly installed

Phase 2 is the operational qualification or “At rest” testing. Testing occurs when equipment is installed but not operating, and no employees are present. This proves that the equipment works properly to achieve the required environmental conditions.

Phase 3 is what is referred to as performance qualification. In this phase, testing is performed with all equipment installed and operating and employees performing their regular work duties and tasks. This testing proves that the cleanroom has the required operational performance for the cleanroom application.

Once initial certification is complete, it is important to regularly recertify to ensure that your cleanroom continues to operate as it did when it was built.  At a minimum, annual certification is recommended. Depending on industry and product, semi-annual or even quarterly certification may be required.

Need a cleanroom to meet ISO or other standards? Angstrom Technology can design it and build it!

 

Choosing the Right Cleanroom Design and Installation Company

Choosing the Right Cleanroom Design and Installation Company

For facilities requiring a clean environment, the cleanroom itself is a crucial component. As a general contractor or builder, you know that finding the right company to design/build and service, your cleanroom is a critical part of your projects success. How do you choose the right cleanroom design company? Here are some qualities a good cleanroom design company should have:

Good communication—quick response times

Communication is essential in any construction project, and it’s vital for subcontracted work. The cleanroom design company that you chose should give respond quickly with a budgetary quote, and be able to answer any technical questions you may have in the design/build portion of your project. Once the project is underway supply you with weekly project updates, keeping your timeline in check.

Fast lead times and ability to meet deadlines

You don’t have months and months to get this cleanroom constructed—you need it done quickly and efficiently, within your timeframe. You have deadlines that you have to meet, and the cleanroom designer should understand and respect that. Given a reasonable amount of time and all the necessary information to complete the cleanroom project, a good cleanroom design firm should be able to make quick turnaround times and keep the cleanroom, and therefore the rest of your project, on schedule.

Customization capabilities

Good cleanroom designers will work with you to create the right cleanroom for the client, and this may include custom requests. Good designers aren’t inflexible—they won’t just provide a boilerplate, cookie-cutter, one-size-fits-all cleanroom, because the needs of each client are unique, based upon cleanroom application and other circumstances. The cleanroom design firm you choose should be willing and able to design custom elements such as casework, cleanroom benches, and tables, to fit the client’s specific needs.

Ability to stay on budget   

Cleanrooms can be an enormous cost for your client, and as such, the budget must be respected. If a cleanroom designer can’t stick to the agreed-upon budget, the project can’t succeed, and problems will arise for all parties, the cleanroom design company, you, and the client. Good cleanroom designers will be able to provide a workable cleanroom design within budget constraints.

Selecting the best company for your cleanroom design and installation project is the first and most essential step in providing your client with the cleanroom their company needs. Finding a cleanroom design company with good communication practices, quick turnaround times, the ability to customize, and budget-consciousness will ensure that your cleanroom design is a success.

If you’re tasked with a cleanroom design project and have questions about designing a new cleanroom, give the experts at Angstrom a call. We install all kinds cleanrooms and have a selection of necessary cleanroom equipment and supplies.

New Trends in Cleanroom Design

New Trends in Cleanroom Design

Now that the holidays are over and the new year has begun, you might finally be getting around to implementing a new cleanroom in your facility. If you’re designing a new cleanroom or updating your current one, here are the latest trends in cleanroom design that you should consider as you design your cleanroom space.

 

Sustainability

Sustainability is an important consideration for all of us, including corporations. Because cleanrooms use so much energy to maintain the desired environmental conditions, engaging in sustainable practices when possible is crucial. Not only do these sustainability efforts support the natural environment, they are also energy efficient, which can help you save on energy costs. Using energy efficient equipment and energy efficient LED lighting can aid in sustainability efforts, as can a modular cleanroom. Modular cleanrooms can be altered and right-sized as the needs of your company change, while reusing the modular components, and require less material than traditional construction. Additionally, modular cleanrooms can make use of the currently existing HVAC and ventilation systems in your space, rather than requiring separate systems.

 

Transparency

Now, more than ever, we’re aware of the value of transparency from leaders and companies. When it comes to your cleanroom, the primary concern will always be the integrity of the controlled environment within, and it may also be important to maintain privacy for the safety of intellectual property, but cleanrooms can benefit from some openness and visibility. Using transparent partitions in the place of opaque walls can provide some benefits, the biggest of which being that lab processes can be observed, whether by compliance regulators or supervisors within your organization, without disturbing cleanroom processes or the environment within.

 

Flexibility

Many organizations are resisting the use of specific dedicated spaces for certain tasks or operations, instead opting for more shared spaces and flexibility in order to reduce costs and under-utilized space. This means incorporating fixtures and furniture, such as lab benches and workstations, into your cleanroom that can accommodate a variety of tasks or processes, as well as modular cleanrooms that can be easily expanded, contracted, or reconfigured to maximize use of space.

 

As you’re working on your cleanroom design or redesign, consider the needs of your company and your cleanroom, as well as how the cleanroom can continue to meet those needs over time, with organizational and regulatory changes. Incorporating sustainability, transparency, and flexibility into your cleanroom design can make your cleanroom efficient and future-proof, not matter the changes to come.

Looking to design a new cleanroom? Get in touch with the cleanroom experts at Angstrom Technology.

What is the Difference Between a Controlled Environment and a Cleanroom?

What is the Difference Between a Controlled Environment and a Cleanroom?

The words cleanroom and controlled environment are often used interchangeably when talking about environment control in critical spaces. But there is a difference, and that difference is crucial. When it comes to controlled environments vs. cleanrooms, here’s what you need to know:

 

What’s a controlled environment?

 

A controlled environment, or critical environment, is an area that must have certain parameters controlled, specifically, pressure, temperature, and segregation. Many laboratories are considered controlled environments, as they have controlled temperature and pressure and are separated from other operations, such as manufacturing or shipping. Unlike cleanrooms, controlled environments do not necessarily have to meet certain standards for particle contamination.

 

What’s a cleanroom?

 

A cleanroom is a type of controlled environment, but one with much more stringent requirements. Cleanrooms require temperature and pressure control, as well as separation from the outside environment and other operations, but these things must be controlled to specific standards. Cleanrooms are classified by the maximum acceptable numbers of particles (by size) in the air per cubic meter, and must be regularly tested to ensure compliance to that standard (see more about cleanroom classifications here). Compared with other controlled environments, cleanrooms may require more energy, air, and advanced technology to maintain the cleanroom conditions.

 

Which do I need, a cleanroom or a controlled environment?

 

This depends on two factors: your application and your industry. If you’re packaging medical devices, you’ll need an ISO class 7 complaint cleanroom, or higher. If you have a process control laboratory for a chrome plating company, you aren’t required to meet a specific ISO classification, but definitely need to control the environment. You may even have different needs within your facility; you may need a controlled storage environment for sensitive materials that may not need to meet cleanroom standards, but have and ISO class 8 cleanroom for quality control testing.

 

Angstrom has the experience and knowledge to design the right cleanroom for your application. Contact us today to find out more!

How to Control Humidity in Your Cleanroom

How to Control Humidity in Your Cleanroom

Controlling the humidity in your cleanroom is crucial, not only to meet government and company specifications, but to protect the integrity of your processes and product. If the humidity is too high, bacterial growth can flourish, metal products or equipment can corrode, photolithographic degradation can occur, and condensation and water absorption can occur. If the humidity is too low, static buildup and discharge can become an issue. Plus, poorly controlled humidity can make working conditions uncomfortable for your employees. What are some of the methods you can use to control humidity in your cleanroom?

Air conditioning/mechanical refrigeration

Humidity is relative, meaning that the lower the temperature is, the lower the relative humidity is. It makes sense then if you lower the temperature in the space, the humidity will decrease. When using air conditioning systems to dehumidify a space, the system lowers the temperature of a surface to a temperature below the dew point of the airstream in the cleanroom. The surface is exposed to the airstream in the cleanroom, and the water vapor in the airstream condenses, subsequently dehumidifying the space. To maintain the desired room temperature, the air must be re-heated and piped back into the cleanroom.

Desiccants

Desiccant systems draw air through a desiccant medium, which absorbs moisture. The dehumidified air is then routed to the cleanroom. Unlike consumer-grade desiccant systems, which collect condensate in a receptacle that must be emptied (if you’ve ever had a dehumidifier in your home, say in a finished basement, which can trap moisture, you’ll recall having to empty the condensed water), commercial systems exhaust humid air through the ductwork, out of the building. This allows for greater dehumidifying power and the ability to dehumidify to lower relative humidity levels at lower temperatures.

These systems are not mutually exclusive, in fact, both work best when used in conjunction, especially where temperature control is also important, as in a cleanroom. Using a desiccant system in addition to air conditioning can also help reduce the load on the HVAC system, saving energy, wear and tear on the HVAC system, and, of course, money.

Humidity control is absolutely critical in some cleanroom applications, such as semiconductor manufacturing and pharmaceutical manufacturing, but it is an important consideration no matter your application. Monitoring and controlling your cleanroom humidity, whether through air conditioning/mechanical refrigeration, a desiccant system, or both, is necessary to meet your cleanroom’s specifications and to ensure cleanroom integrity.   

No matter your application, Angstrom can design a cleanroom to meet your cleanroom needs. Contact us to discuss your cleanroom project.