What is the equivalent ISO class for cGMP areas?

What is the equivalent ISO class for cGMP areas?

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

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.