5 reasons you need a modular cleanroom

5 reasons you need a modular cleanroom

by | Dec 9, 2022 | Cleanrooms, Modular Construction

At Angstrom Technology, our modular cleanrooms are a popular choice for organizations looking to create cleanroom space quickly. Here are just 5 reasons you need one.

 

1.     Flexibility to extend or relocate

If you need some cleanroom space right now but know you may soon need a larger area — don’t be held back by your future plans! Our modular cleanrooms can be extended or relocated. So your investment is futureproofed against any changes to your requirements — planned or unplanned!

 

2.     Self-installation option for modular cleanrooms

If your team is particularly hands-on, you can choose the self-assembly option. Since our modular cleanrooms are prefabricated at the factory, it will only take you about 2-3 days to install it. Or, you can hire the technicians at Angstrom Technology to put it together for you. Our team will manage the project from delivery to validation, with minimal distraction, so your team can get on with their workload.

 

3.     Protect your injection molding machines

Are you an injection molder? Are you looking to protect the tool face of your molding machine without enclosing the hopper? Look no further! Our modular SoftWall cleanrooms are the solution to your challenges. Many molders have used them to protect the critical zone, as the SoftWall curtains can be profiled around a machine to give part coverage and create an ultra clean zone where it counts.

 

4.   Use a modular cleanroom for R&D

Our modular RigidWall cleanrooms can quickly upgrade your R&D zone to create a classified environment. Many sectors, like medical device, space, and manufacturing, have taken advantage of this ultra-quick solution to protect their intricate and sensitive products.

 

5.     Medical device production

Our RigidWall modular cleanrooms can achieve particle counts according to ISO Class 5-8 requirements. What does this mean for medical device manufacturers? If your quality risk-based assessment deems this suitable, you can manufacture your medical devices in them!

 

Build an ISO Modular Cleanroom With Angstrom Technology

At Angstrom Technology, we’re proud to have delivered high-quality, high-performance cleanrooms across North America for over 30 years.

If you’re interested in building an ISO cleanroom in your facility, contact us online for information on how to get started.

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RigidWall Cleanroom Features

RigidWall Cleanroom Features

by | Nov 14, 2022 | Cleanroom Standards

Planning to install a new cleanroom in your facility? One of your first steps should be to figure out which type of cleanroom is the best fit: SoftWall, HardWall, or RigidWall. All of these have great features and performance capabilities, but one of them may work better for your application than the others. That’s where we come in — to help you narrow down your options. 

We’ve already published blogs about SoftWall and HardWall cleanroom features (check them out if you haven’t yet!). So, this article will finish up the series by diving into RigidWall cleanrooms. We’ll discuss what they are, what unique features they offer, and what benefits they could bring to your facility. 

What Are RigidWall Cleanrooms?

RigidWall cleanrooms are constructed with aluminum extrusions, and are somewhat of a mixture between HardWall and SoftWall cleanrooms. They are durable and flexible, much like the HardWall, and more robust than the SoftWall. They have the same once-through configuration and design that SoftWall cleanrooms offer. 

You might recognize a RigidWall cleanroom by paying attention to one specific aspect of them: aesthetics. RigidWall cleanrooms are generally built with transparent panel inserts that provide full visibility into the room, from floor to ceiling. 

Because of this trait, RigidWall cleanrooms are a common choice for applications that require the transparency aspect. This could include processes that require outside monitoring and safety or use as a show piece for new and potential customers.

RigidWall Cleanroom Features

Just like the other types of cleanrooms, RigidWall cleanrooms can be customized to meet specific customer needs. However, every RigidWall cleanroom does have a certain list of basic features. We’ll walk through them in the three sections below. 

RigidWall Cleanroom Materials

The most prominent material in RigidWall cleanrooms is their transparent wall panel inserts. We outline those, as well as some of their other structural materials below: 

  • Wall Panels – RigidWall panels are prefabricated utilizing high-strength aluminum extrusions that are finished with white powder baked enamel with ¼” inserts. They can be composed of ¼” acrylic, static dissipative PVC, or polycarbonate. The inserts can be either clear or opaque.
  • Ceiling System – The RigidWall structural ceiling system follows a T-grid layout, and is composed of 2” extruded aluminum framework. It holds necessary equipment like fan filters, ceiling tiles, and lighting.
  • Entrances – RigidWall cleanrooms are compatible with the same types of entrances as HardWall cleanrooms: swing doors, overhead doors, automatic or manual sliding doors, and more. 

RigidWall Cleanroom Sizes

No matter the size of your cleanroom, a RigidWall solution can meet the requirement. Standard rooms are available in 2’x4’ increments and can free span up to 30’. Their standard prefabricated panels are available in the same size as HardWall panels — so 4’ wide and 8’ tall nominally. 

RigidWall Cleanroom Standards

Due to their solid, durable wall systems, RigidWall cleanrooms are capable of meeting ISO classification between ISO Class 5-8. 

Benefits of RigidWall Cleanrooms

RigidWall cleanrooms aren’t the most common type of cleanroom we build at Angstrom Technology, but they’re highly rewarding solutions for the right applications. Below are some of the unique benefits they offer. 

Sleek Appearance

RigidWall cleanrooms’ transparent appearance offers a sleek, transparent style that other types of cleanrooms don’t. For applications that require full visibility into the cleanroom, this is a great option. 

Good Contamination Control

RigidWall cleanrooms offer control over contamination, static, pressure, and airborne particulates. As mentioned above, their level of control can meet ISO Class 5-8 requirements. 

However, it should be noted that RigidWall cleanroom panels don’t have the insulation properties needed for regulating temperature and humidity. If your application requires stringent temperature and/or humidity control, a HardWall cleanroom is a better option. HardWall cleanrooms offer great control over contamination, particulate matter, and temperature and humidity. 

Great Reconfigurability

Since RigidWall cleanrooms are constructed with prefabricated, modular wall panels, they can be easily reconfigured to change with you. As your facility evolves and grows, your RigidWall cleanroom can seamlessly evolve and grow too. It also improves the ability to include new types of equipment or technology within your cleanroom if need be. No matter what your needs are or may be in the future, a RigidWall cleanroom is a long-lasting solution. 

Extreme Durability

High-strength 6063-T6 aluminum extrusions, a robust 2” ceiling system, and reliable structural framework make RigidWall cleanrooms highly durable. Their coat of white, powder-baked enamel prevents corroding and contamination. Also, because the system requires no drilling and tapping, it’s quite clean and easy to install.

Simple Cleaning & Maintenance

RigidWall cleanrooms have non-porous surfaces and specific powder baked enamel finishes that make routine cleaning easy without rust or corrosion. You can wipe down all of these surfaces with cleanroom-approved cleaning products quickly and easily. This is a great advantage, especially for cleanroom applications that require very frequent cleanings to ensure their safety. 

Interested in installing a RigidWall cleanroom in your facility, or have questions about which type of cleanroom is right for your application? Let us know! Our cleanroom design and installation team can deliver a solution that meets your unique specifications. Give us a call at (888) 768-6900 or contact us online today. 

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What is the equivalent ISO class for cGMP areas?

What is the equivalent ISO class for cGMP areas?

by | Oct 31, 2022 | Cleanrooms

At Angstrom Technology, we get asked a lot what the equivalent ISO class for a cGMP area is. Particularly from organizations at the start of a cleanroom project. Here, we answer that question for you.

The International Standard for cleanrooms and associated controlled environments is ISO 14644. To be classified as a cleanroom, zones must meet air cleanliness levels that are classified by particle concentration limits detailed in ISO 14644-1. While ISO 14644 governs all cleanrooms, the FDA Current Good Manufacturing Practice (cGMP) is specifically for medicines manufacturers. It describes the minimum standard they must meet in their production processes.

What are the different cGMP areas?

Two clean areas are of particular importance to sterile drug product quality in cGMP. These are the critical area and the supporting clean areas associated with it. Each area has a minimum recommended ISO class. Although, with ISO validation two particle sizes are usually considered, whereas cGMP standards dictate that only particles ≥ 0.5 μm should be controlled.

EU GMP takes a slightly different approach. Four grades (A-D) are detailed. Since each grade has particle concentration limits, there is an equivalent ISO class for each cGMP grade. Although they are not mentioned in cGMP guidance, these grades are becoming part of the common cGMP language in the US.

  • EU GMP Grade A is approximately equivalent to ISO Class 5
  • EU GMP Grade B is approximately equivalent to ISO Class 5
  • EU GMP Grade C is approximately equivalent to ISO Class 7
  • EU GMP Grade D is approximately equivalent to ISO Class 8

Need more information on the ISO particulate concentration limits? We have a table that breaks them down on our cleanroom classifications page.

What ISO Class Should Critical Areas Meet?

Critical areas must meet particle concentration limits according to ISO Class 5. These areas are equivalent to EU GMP grades A/B.

A critical area is one where the sterilized drug product is exposed to environmental conditions that must maintain product sterility. Activities conducted in such areas include aseptic processes. This can include manipulations of sterile materials before and during filling and closing operations.

Because an exposed product is vulnerable to contamination and will not be subsequently sterilized in its immediate container, this area is critical.

What ISO Class Should Supporting Clean Areas Meet?

Supporting clean areas must meet a minimum of ISO 7 (equivalent to EU GMP grade C). Depending on the activity in these areas, manufacturers can also classify them as ISO 6 or maintain the entire aseptic filling room at ISO 5.

Supporting clean areas can have various classifications and functions. Many support areas function as zones in which nonsterile components, formulated products, in-process materials, equipment, and container/closures are prepared, held, or transferred. These environments are soundly designed when they minimize the level of particle contaminants in the final product and control the microbiological content (bioburden) of articles and components that are subsequently sterilized.

Build a cGMP-Compliant Cleanroom With Angstrom Technology

At Angstrom Technology, we’re proud to have delivered high-quality, high-performance cleanrooms across North America for over 30 years.

If you’re interested in building an ISO or GMP-compliant cleanroom in your facility, contact us online for information on how to get started.

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The CHIPS Act: Designing your Semiconductor Cleanroom

The CHIPS Act: Designing your Semiconductor Cleanroom

by | Oct 13, 2022 | Cleanrooms

On August 9, 2022, President Biden passed the CHIPS Act.

What’s that? We’re here to fill you in. 

The CHIPS Act

CHIPS stands for Creating Helpful Incentives to Produce Semiconductors for America Act. The investment promises $50 billion to domestic R&D and manufacturing, marking a seminal moment for US semiconductor manufacturing.

This article looks at how organizations can use the funding to create a cleanroom space that supports the semiconductor supply chain.

What does the CHIPS Act mean for OEMs?

The CHIPS Act presents an opportunity for semiconductor R&D companies and manufacturers—along with their supply chain—to upgrade or extend facilities.

The program also intends to incentivize new participants to the semiconductor industry, allowing companies in vertical industries, such as electronics manufacturers, to diversify with reduced risk.

Funding will be available for a range of purposes, including the following:

  • Construction or expansion of facilities for the fabrication, packaging, assembly, and testing of legacy and current-generation semiconductors
  • Facilities to produce new or specialty technologies or emerging technologies
  • Facilities that manufacture equipment and materials for semiconductor manufacturing, potentially co-located in regional clusters

Entering the semiconductor market

The cost of semiconductor fabrication plants—often termed semiconductor fabs—can run into the billions of dollars. This creates a significant barrier that has obstructed new entrants into the market. But to be part of the supply chain, a semiconductor fab is not essential.

Before they are scaled up to industrial production, there are pre-commercial activities that need to be conducted to research, develop, and learn about new products. A semiconductor pilot plant can produce small volumes of chips for R&D purposes.

Since chips are highly susceptible to damage, even the smallest particle could cause a defect. This is why the specification for semiconductor chip fabrication cleanrooms typically ranges from ISO class 4 to 6. A HardWall cleanroom would be able to achieve this level of particulate control for a pilot plant. Zones can provide segregated spaces with control of environmental parameters—such as temperature, humidity, and UV—to be optimized for various steps of the production process.

The packaging, assembly, and testing of circuits or chips could be performed in ISO class 7 or ISO class 8 cleanrooms, with all considerations handled on a project-by-project basis. Equipment can be enclosed in a modular cleanroom, either RigidWall or SoftWall construction.

Over the years, Angstrom Technology has served the semiconductor industry with a wide range of cleanrooms. We’ve put together a simple guide to help you understand more about what type of cleanroom is suitable for your process.

 

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Whether you are an existing semiconductor specialist or looking to diversify — the Angstrom Technology team can support your organization.

Contact Angstrom Technology to discuss your semiconductor cleanroom

Our cleanrooms are proudly made in America. We have the expertise to support organizations looking to build domestic capacity in line with the principles of the CHIPS program.

Are you thinking about investing in a semiconductor cleanroom? Request a semiconductor cleanroom quote today, or contact our team of experts for more information.

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