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.

All About E-Liquid Cleanrooms

All About E-Liquid Cleanrooms

With the surge in popularity of electronic cigarettes, the need for regulation and standardization of e-cigarette and e-liquid manufacturing has emerged. In May 2016, the FDA issued a final rule which brought these products under its authority. In addition to regulatory compliance, cleanrooms for e-liquid manufacture allow for quality control and product consistency by providing a controlled environment free of harmful contamination.

The American E-liquid Manufacturing Association dictates a dedicated “lab/mixing space” and that manufacturing processes meet food preparation standards. (Click here to see the current AEMSA standards.) E-cigarette and e-liquid manufacturing is now regulated by the FDA, which is working to require that these products be manufactured within a controlled cleanroom environment. The necessary cleanroom classification is dependent upon the specific product and process, but e-liquid manufacturing would generally require cleanrooms to meet and be certified to ISO Class 7 or ISO Class 8 standards.

When it comes to installing a cleanroom for your e-liquid manufacturing business, sooner is better than later, especially with FDA legislation looming. Modular cleanrooms are one of the best options for e-liquid cleanrooms for a variety of reasons. Modular clean rooms have better lighting options than traditionally constructed spaces, as well as greater flexibility since modular cleanrooms can be easily reconfigured or expanded when your operation changes. They are often less expensive and time-consuming to install than traditional construction and offer greater flexibility when it comes to location and placement. Modular cleanrooms are essentially self-contained and can be placed nearly anywhere in your space for greatest efficiency and convenience, even in the middle of a large warehouse-type building.

Additionally, various parts of your process may require different levels of cleanroom control. Hardwall cleanrooms provide the highest level of control over contamination, humidity, and pressure, and are ideal for manufacturing activities and quality control testing; softwall cleanrooms can provide clean, contaminant-free space for e-liquid bulk storage.

As demand for e-liquid increases, so does consumer and regulatory scrutiny on its manufacture. Manufacturing e-liquids in a cleanroom environment is becoming a necessity, and ensuring that the cleanroom meets the industry ISO standard and your company’s needs is an important consideration.

Designing a cleanroom for your e-liquid company? Call Angstrom Technology. We have the experience and the technology to create the cleanroom you need.

 

Frequently Asked Questions About Cleanroom Classifications

Frequently Asked Questions About Cleanroom Classifications

Cleanroom classification is one of the most confusing – yet important – parts of designing and building your cleanroom. If you’re installing a cleanroom for the first time, you’re bound to have a lot of questions. Here are some answers to the most common cleanroom classification questions we receive.

 

1. What classification do I need?

It depends on your industry. The requirements will vary depending upon what size particles need to be filtered, the sources of contamination present, and recommended air change rate. If your industry is government regulated, you can check applicable regulation to see what classification is required. If there is no government-mandated or industry default classification, you’ll need to determine the appropriate classification, based on your application.

 

2. How are cleanrooms classified?

There are two different classification scales that are generally used, the U.S. General Service Administration standards (FS209E) and International Standards Organization (ISO) classifications. The classes are determined by the maximum acceptable numbers of particles (by size) in the air per cubic meter. See Cleanroom Classifications & Standards here.

 

3. How often do I need to test my cleanroom to see if it’s meeting classification requirements?

ISO requires that air pressure difference and air flow be tested every 12 months for all classifications. Particle count tests must be performed every 12 months ISO Class 6 and above, every six months for ISO Class 5 and below. There are also tests recommended for all classes, every 24 months: installed filter leakage, containment filter leakage, recovery, and airflow visualization. These tests are regulated by ISO document 14644-2 Cleanroom Testing and Compliance.

 

4. How often do I need to have my cleanroom inspected?

This depends on your classification. The more stringent classifications will require more regular inspection. Inspection may coincide with compliance testing, which, depending upon the cleanroom classification may occur every six or 12 months.

 

5. How does cleanroom classification affect my budget?

Essentially, the more stringent the classification, the greater the cost. Strict classifications will require more air, energy, advanced technology, and equipment. See How Does Cleanroom Classification Affect Your Cleanroom Budget? for a more detailed breakdown of the costs.

 

If you have more questions about your cleanroom classifications, check out our post What You Need to Know About Cleanroom Classifications, and make sure to give Angstrom a call! We’d love to help.

 

Benefits of Modular Cleanrooms

Benefits of Modular Cleanrooms

If you have a cleanroom, are installing a cleanroom, or are considering whether your company needs a cleanroom, you already know why cleanrooms are important and necessary for your operations. You may not have considered, however, the type of cleanroom: a traditionally constructed space or a modular cleanroom. Modular cleanrooms have numerous benefits when compared to traditional construction, here are just a few:

 

Modular cleanrooms are free-standing

A free-standing cleanroom can be placed nearly anywhere, without extensive construction or renovation (and the costs and disruption those processes entail). If you have a free-standing modular cleanroom, you’re able to place it in the optimum location–whether that is the middle of a large open production floor or tucked back in a corner. You don’t need to build walls or change existing ones. Additionally, electricity and plumbing are already engineered into the cleanroom as part of the modular design.

 

Modular cleanrooms are quickly built

Building something from a kit, with the building materials included and the design already completed is always a simpler, easier, and quicker process than starting from scratch. Installing a modular cleanroom streamlines the building process–the design is complete, the materials selected and included, and construction simple and straightforward.

Just as modular cleanrooms are easy to assemble, they can also be easily disassembled, when compared to permanent construction. If you decide to move your cleanroom’s location within your facility or move it to a new facility, it can be quickly taken down and rebuilt in the new space.

 

Modular cleanrooms are easily modified or expanded

Should your company’s cleanroom needs ever change, modifying a modular cleanroom is much easier than renovating or remodeling a traditionally constructed space. Modular cleanroom walls are easily moved to accommodate a new cleanroom layout, and they can be expanded by adding additional wall pieces. You don’t need to start fresh with all new materials every time your cleanroom needs change.

A modular cleanroom can be a benefit for your company when you consider their flexibility, portability, and ease of installation and modification. Modular cleanrooms allow you to customize your cleanroom space to the ever-changing and evolving needs and capabilities of your company, and they are an excellent cleanroom solution that can save time and money.

 

Angstrom is a leader of the modular cleanroom industry. Whatever the size and classification of your project, we can design a cleanroom that fits your specifications. Contact us for more information.