ISO Cleanrooms Archives - Allied Cleanrooms

Modular cleanroom by Allied Cleanrooms designed to control viable and non-viable particles

April 25, 2026

Viable vs. Non-Viable Particles in Cleanrooms

It should go without saying that not all particles in a cleanroom are the same, even though ISO standards may appear to treat them as such. Some are inert, like dust, while others are alive and capable of multiplying. Before building a cleanroom, it’s important to un...

Interior of a 503B cGMP cleanroom built by Allied Cleanrooms, showing smooth wall panels, return air grilles, and a pass-through chamber.

February 26, 2026

503B cGMP Cleanroom Design: What Outsourcing Facilities Need

Just because a 503B cGMP cleanroom passes an initial certification, it can still later fail an FDA inspection. More often than not, the problem can be traced back to how it was designed. For 503B outsourcing facilities, the FDA expects evidence of ongoing control. If...

Cleanroom environment consistent with a 503A sterile compounding facility.

February 13, 2026

503A cGMP Cleanrooms: What They Are And What They Aren’t

Pharmacies that start work on a new cleanroom may hear the term “cGMP” used next to 503A. This can, of course, create some real confusion about what is required. Is cGMP something that 503A pharmacies have to follow in general, or is it just a higher standard that so...

Modular cleanroom corridor with interior windows and sealed doors, built by Allied Cleanrooms for optimized post-build cleanroom planning.

November 12, 2025

Post-Build Cleanroom Planning: What to Know Early On

Before your cleanroom is built, it can look perfect on paper or in theory. You may even feel good about having designed an efficient space. The only problem is that it has never been tested in real life. That’s when businesses discover they can’t access the HEPA filters...

Modular cleanroom (designed via a cleanroom URS) interior by Allied Cleanrooms with pass-through chamber and wall windows.

November 2, 2025

How to Create a Cleanroom URS: A Short Guide

When planning a cleanroom or starting a checklist, it’s very tempting to jump straight into the design. However, before any quotes, you’ll need a clear URS (user requirement specification). In this guide, we’ll cover what a cleanroom URS is, what to include within it, a...

Technician in full protective suit performing cleanroom testing at an Allied Cleanrooms facility.

July 17, 2025

Cleanroom Testing: A Few Common Procedures

Unfortunately, just because a cleanroom looks clean does not always mean it is clean enough or compliant. Since particles and airflow are often far too difficult to see with the eyes alone, several cleanroom testing methods can be employed to help reveal problems with y...

Interior of a modular cleanroom by Allied Cleanrooms, featuring a pass-through chamber, observation window, and work station.

June 4, 2025

USP 797 Cleanrooms: Definition, Requirements, and Design

USP 797 is more than just a set of guidelines; its rules were designed to protect patients. And it does this by making sure sterile medications are prepared safely in controlled environments. A cleanroom is one such environment, and one of the most important of any m...

In-progress modular cleanroom by Allied Cleanrooms featuring glass wall panels, a partially installed ceiling grid, and a high-gloss epoxy floor. The cleanroom overlooks an active manufacturing area and is designed for scalable, controlled environments.

May 27, 2025

Cleanroom Design: An Introduction

Cleanroom design can seem difficult or overly technical at first. This is not far from the truth, but understanding the basics is much easier than most people think. In short, designing a well-functioning cleanroom is all about controlling the environment, especially wh...

Automotive paint cleanroom by Allied Cleanrooms with modular walls and integrated lighting, designed for controlled painting or coating applications.

May 21, 2025

Automotive Cleanrooms: Definition, Design, and Standards

Without adequate protection during manufacturing in the auto industry, recalls, safety issues, and legal problems may arise. The auto industry is no stranger to dangers of all kinds, and it’s for this exact reason that parts must be handled safely throughout the manufac...

Modular cleanroom by Allied Cleanrooms with white panel walls, a smooth flooring system, and a grid ceiling with integrated lighting. The room features a pass-through chamber, multiple doors, and ventilation panels, designed for controlled environments requiring high cleanliness standards.

May 6, 2025

Cleanroom Requirements for Pharmaceuticals: A Short Guide

To create a compliant cleanroom, it takes more than simply air filters. These spaces are highly engineered environments with very strict rules and regulations, especially when it comes to pharmaceuticals. In fact, the cost of getting things wrong is so dangerous that on...

A man in gowning works in an ISO 4 cleanroom by Allied Modular.

April 17, 2025

The Costs Involved with Over- or Under-Engineering a Cleanroom

Many people believe that it seems safer to overbuild a cleanroom “just in case.” After all, if a space is cleaner than necessary, isn’t that obviously better than the alternative? Not always. In fact, over-engineering can lead to increased construction costs, oversiz...

A clean, well-lit modular cleanroom hallway with white panel walls and glass windows, designed by Allied Cleanrooms.

March 5, 2025

Cleanroom Air Change Rates: Requirements and Importance

If your cleanroom falls short on air change rates, it won’t just be a minor issue; it’s a compliance risk. Regulations often demand strict air change requirements in order to prevent contamination, protect products, workers, and consumers. If your cleanroom fails to mee...

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