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.

Hardwall vs. Softwall Cleanrooms

Hardwall vs. Softwall Cleanrooms

by | Jul 11, 2018 | Cleanrooms

If you’ve been looking into cleanroom options for your company, you may have come across the terminology “hardwall” and “softwall” in reference to different types of cleanrooms. But, what’s the difference in those types of cleanrooms? And how do you know which is right for your application? Let us break it down for you.

Hardwall Cleanrooms

Hardwall cleanrooms mimic traditional construction in that they have solid walls (hence the name) but retain greater flexibility. The benefits of hardwall cleanrooms are numerous:

  • Existing HVAC incorporation—hardwall cleanrooms can utilize your building’s existing HVAC while maintaining your cleanroom standards.
  • Mounted equipment—hardwall cleanrooms can be designed around already mounted equipment that is floor mounted or ceiling mounted.
  • Strong environmental control—hardwall cleanrooms allow you total control over your cleanroom environment from static and temperature to particle decontamination to meet even ISO Class 1 standards
  • Able to modify—hardwall cleanrooms have a modular design that makes it easy to expand or upgrade as your cleanroom needs change.     
  • Durable—hardwall cleanrooms have a durable frame and strong ceiling grid, so they last for a long time and never sag.

Hardwall cleanrooms are excellent for large cleanrooms and traditional cleanroom applications and can work well when strict environmental control is necessary.

Softwall Cleanrooms

Softwall cleanrooms function essentially like a tent, they are made of flexible material, unlike traditional walls, and can be freestanding or suspended from your existing structure. Some of the benefits of softwall cleanrooms include:

  • Affordability—softwall cleanrooms require minimal materials and are simple in design, making them a budget-friendly option.
  • Customizable—softwall cleanrooms are super flexible and can easily be customized to your application with the necessary HEPA or ULPA filters or required door type.
  • Flexible—softwall cleanrooms are light and can be easily moved, whether freestanding or attached to your existing structure.
  • Easy to install—softwall cleanrooms can be installed in just a few hours, with minimal tools
  • Space-saving—softwall cleanrooms tend to be compact and can fit nearly anywhere.  

These attributes make softwall cleanrooms great for temporary cleanrooms or cleanrooms requiring less stringent classifications, such as storage applications.

Angstrom Technology is a leader in the design, construction, and installation of both hardwall and softwall modular cleanrooms. Call us today for more information on which is right for your application!

 

Choosing the Right Cleanroom Design and Installation Company

Choosing the Right Cleanroom Design and Installation Company

by | May 7, 2018 | Cleanroom Design, Cleanrooms, Helpful Tips

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 and installation 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.

What to Think About When Choosing Cleanroom Furniture

What to Think About When Choosing Cleanroom Furniture

by | Mar 9, 2018 | Cleanroom Design, Cleanroom Supplies

Designing a cleanroom comes with a huge set of unique challenges: controlling the temperature, air quality, static, water purity, etc. What can get overlooked during a cleanroom design is the fixtures and furniture, which are extremely important to the efficiency and ergonomics of your cleanroom space. Here are the questions you should ask when selecting casework and furniture for your cleanroom:

What types of chemicals and materials will be used?

Depending on the substances that you’ll be using in the cleanroom, you may need to ensure that you select work surfaces that are chemical resistant, heat resistant, stain resistant, or non-conductive. This will also inform whether you’ll need fume hoods or chemical or hazardous material storage.

What processes will be performed?

This determines the number and types of workstations you’ll need, as well as their layout. If your cleanroom is used for clean storage of sensitive materials, you’ll probably need cabinetry, shelving, and casework, but if your cleanroom is used for quality control testing, you’ll likely need workstations with storage, sinks, electricity and more.

How often will things change?

If you need flexibility for when processes change, or your cleanroom houses multiple different operations. You may need to consider the flexibility and changeability of the furniture you choose. This can be accomplished with adjustable height tables, workstations or casework on wheels, or adjustable cabinetry that allows you to reconfigure the drawer and cabinet locations.

How many chairs do you actually need?

This seems trivial, but can be a major issue for efficiency. Too many chairs mean there’s always one in the way, and that space is wasted. Too few seats leave your employees playing musical chairs all day. Consider ergonomics with chairs and ensure they are the right height and comfort level for their application. Stools may be the most appropriate choice for cleanrooms where technicians sit for short periods of time at counters; however, if your employees are sitting at workstations for long periods of time for certain operations, they’ll need more comfortable seating.

How much storage is needed?

No matter your cleanroom application, you’ll need storage of some kind, whether for materials, packaging, or the tools and equipment used in your processes. Ensuring that you have the right kind of storage for these items is also important. While shelving may work for bulk storage of boxed items, you’ll need cabinets for chemical storage or racks and drawers for tools.

How much space do I have?

If you’re working with limited space, it’s critical that you maximize that space. Too much furniture can impede movement and therefore,  the efficiency of your cleanroom operations. Consider how spaces can be made flexible for multiple operations or how the furniture can be best laid out for process flow, as well as the movement of people within that space.

 

When designing or upgrading a cleanroom, don’t forget the furniture. Using your cleanroom space inefficiently or having the wrong furniture or materials, or simply not having enough storage or seats can make a cleanroom into a chaotic mess. Ask yourself these questions when selecting cleanroom furniture to ensure a well-designed cleanroom for your application.

 

If you’re designing a new cleanroom, make sure you have the right space to meet your needs. Angstrom Technology can design, construct and install the perfect cleanroom