Why You Need a Cleanroom, Not Just a Lab

Why You Need a Cleanroom, Not Just a Lab

by | Sep 10, 2018 | Cleanrooms, Manufacturing Cleanrooms

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.

 

Press Release: Angstrom’s New Facility

Press Release: Angstrom’s New Facility

by | Aug 10, 2018 | Uncategorized

Angstrom Technology is pleased to announce that our new facility has finally been completed. The building is located at 3509 3 Mile Road in Grand Rapids, alongside DK Engineered Construction. The new facility is 20,000 square feet and houses our cleanroom, modular office design and build firm, as well as our corporate office. We look forward to settling in to our recently completed and freshly landscaped new home!

Our employees are Angstrom Technology’s greatest attribute, and the quality of our people and their work is unsurpassed in the industry. That’s just one of the reasons we’re so proud to have built a new facility giving our valuable employees a place to call home!

Angstrom Technologies main office is located here in West Michigan, with satellite sales offices in Ohio, Pennsylvania and California.

As an industry leader in cleanroom production, Angstrom Technology’s mission is to be a top resource for cleanroom consulting, design, installation, equipment, and repair. With extensive knowledge of cleanrooms and the industries they serve, Angstrom ensures that our clients get exactly the cleanroom they need for their project.

Come visit us at our new facility and see just what we do, and how our modular cleanroom solutions can work for you. Call or contact us online to get a quote or set up an initial consultation, at our place or yours!

parking-lot-with-sign
parking-lot-with-building
angstrom-technology-sign
parking-lot
Most Common Cleanroom Design Problems

Most Common Cleanroom Design Problems

by | Aug 9, 2018 | Cleanroom Design

Cleanrooms present a lot of unique challenges in terms of design because they have very specific requirements they have to meet. If you’re meeting your desired ISO standard, you might feel like your design is good enough, but the truth is that there are a lot of common issues that companies face when designing cleanrooms. Here are some of the most common cleanroom design problems we see:

Inefficient placement

One of the biggest issues with cleanroom design is inefficiency. If your design doesn’t support your processes, it’s going to cause problems. Consider the various tasks and processes that go on in your cleanroom. Is someone always getting in someone else’s way because of where there workstations or supplies are located? Are there too many processes sharing one sink, causing a bottleneck? Are there drawers or cabinets that you can’t fully open because they’re too close to a wall or door? All of those problems can cause major inefficiency and can be avoided with good design.

Maze-like walkways

The whole point of a maze is inefficiency, it takes a long time to get through a relatively short distance because you have to twist and turn and wind around obstacles. But your cleanroom shouldn’t be a labyrinth. If employees have to walk through narrow paths, wind around oddly placed workstations, or bump into each other constantly to get to the door, their workstations, the sink, or the fire extinguisher, you will have massive safety problems on your hands, not to mention a lot of wasted time and motion on the part of the cleanroom techs.

Poor ventilation

Good ventilation is necessary for any space to be comfortable, but it’s especially crucial in a cleanroom, where you’re trying to maintain a controlled environment with limited particles and contaminants. Additionally, in cleanrooms where hazardous materials are used, good ventilation is a necessary safety concern to ensure the well-being of workers.

Unable to maintain temperature

No one wants to work in a room that’s too hot and stuffy or freezing cold, so for the same of employees comfort and morale, a cleanroom that is a comfortable temperature matters. It’s vital too that your cleanroom can maintain its desired temperature to protect the products, materials, and chemicals stored in it, as they can be sensitive to temperature, and to prevent the growth of mold and bacteria that can compromise the cleanroom environment. This could be a problem with your HVAC, thermostat, or insulation, so be sure to select those things wisely and perform regular maintenance checks.

Good design is the first step to having a well-functioning cleanroom. If you recognize some of the issues we mentioned in your current cleanroom, it’s probably time for a redesign. There are a few things you can do in the meantime to work with the layout you have and increase efficiency, such as rearranging movable cleanroom furniture, moving processes that don’t require a controlled environment to a new area, or simply cleaning out any tools, materials, or storage that is no longer necessary.

Having issues with your cleanroom design? Call the experts at Angstrom Technology.

 

How are Cleanrooms Validated?

How are Cleanrooms Validated?

by | Aug 8, 2018 | Cleanrooms

Validation is an important process for any cleanroom. It serves to ensure that the cleanroom is properly installed and 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!

 

Cleanroom HVAC Systems Explained

Cleanroom HVAC Systems Explained

by | Jul 25, 2018 | Air Circulation

In cleanrooms, air is crucial – how it’s filtered, how it’s heated and cooled, and how it’s circulated. Because of this, knowing how HVAC and filters work together is crucial to maintaining cleanroom air decontamination and meeting cleanroom standards. Before you install a new cleanroom, here’s what you need to know about your cleanroom’s HVAC system:

Dedicated vs. Integrated HVAC

When it comes to cleanroom HVAC systems, the first decision is whether to have a dedicated HVAC system or to incorporate your building’s existing HVAC. This depends on the necessary level of environmental control, the size of your cleanroom, and the other energy requirements of your facilities. Using an existing HVAC system can help you save money at the outset, but for very large cleanrooms or factories, a dedicated system might be more efficient and keep a reasonable load on each system so that they can run efficiently. Additionally, while you can combine a filtration system with an existing HVAC system very efficiently, for extremely stringent cleanroom standards, dedicated HVAC may be your best bet.

Filtration systems

Filtration is also an important consideration here. There are three basic types of filters used in cleanrooms: prefilters, HEPA filters, and ULPA filters. Prefilters are used with both HEPA and ULPA filters as a first step in the filtration process, removing large particles.

HEPA filters are High-Efficiency Particulate Air filters, and they filter out 99.99 percent of particles 0.3µm or larger.

ULPA filters are Ultra Low Particulate Air filters, and filter out 99.999 percent of particles larger than 0.12µm.

Purity Testing

Once your HVAC and filtration systems are in place, you must regularly test the air purity of your system. Testing should occur initially in three phases: as-built testing (when all services are connected and working), at rest (when all equipment is installed and in place), and performance qualification (occurring regularly while the cleanroom is in operation).  

Are you designing a new cleanroom or updating an existing one? Angstrom Technology has the products and expertise you need.