Industry Knowledge
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Good Automated Manufacturing Practices 5 (GAMP5) And Your Cleanroom
The Good Automated Manufacturing Practices (GAMP) were developed by the International Society for Pharmaceutical Engineering (ISPE) for pharmaceutical cleanrooms. The ISPE remains the governing body for GAMP....
Cleanrooms Explained
A cleanroom is a specifically designed room that controls contamination. Cleanrooms are used in practically every industry where small particles can adversely affect the manufacturing process and product. The...
4 Cleanroom Particle Filtration Techniques
How many times have you heard us say, “your cleanroom filtration is critical”? Probably more than once if you’ve spent any time interacting with us. But not all filtration is the same!...
Fill the “GAP” Good Application Practice “How to Test HEPA Filters ”
Your Ultimate Guide To Cleanroom Air Distribution Strategy
We talk a lot about contamination control strategies in a cleanroom, but there is another type of strategy you need to consider: air distribution. This strategy is typically put into place during the planning...
Cleanroom Particle Filtration Basics
Your filters are what separates your cleanroom from just some ordinary, run-of-the-mill room. They stop potentially harmful contaminants from entering the room. They prevent yield loss and harm to the...
Cleanroom Air Filters: Controlling Contamination in The Cleanroom
Photometer vs Particle Counter: Which Is Right For Your Cleanroom?
When you need to classify your cleanroom, do you reach for your trusty photometer or particle counter? Both photometers and particle counters are devices used in cleanrooms to measure particles, but they go...
Your Basic Guide To Aseptic Filling
Your Basic Guide To Aseptic Filling Did you know that aseptic (or sterile) processing in pharmaceutical manufacturing is relatively new? Sterility requirements were established in the 1920s. Later, during...
Aseptic Environment: Nonviable vs Viable Monitoring
Does it matter what kind of particles exist in your cleanroom? Isn't all contamination bad? On the surface, yes. You just need to know if your cleanroom is contaminated or not. Any contamination poses a...
Airborne Particle Counters and How They Work
Good Application Practice: How to Perform Proper Cleanroom Classification
Particle Count Cleanroom Certification versus Routine Particle Monitoring and current GMP requirements
Cleanroom Certification is a process of validation. This validation process certifies that the Cleanroom operating conditions meet the intended design parameters. Room Particle Counts are tested using a...
How To Choose Your Cleanroom Classifying & Monitoring Tools
So you’re going to classify your cleanroom. But what cleanroom classifying tools can you use that will make the process painful and easy? First things first, let’s define cleanroom...
Cleanroom Classification: What Makes A Cleanroom
So what exactly makes a cleanroom… A cleanroom? First and foremost, a cleanroom needs to be clean. You are able to communicate just how clean it is through its cleanroom classification. But you...
6 Water Purification Methods For Cleanrooms
Water. It makes up 70% of our bodies, but, even more importantly, it serves as a vital ingredient and manufacturing component in cleanrooms. Before we are able to introduce it into the cleanroom setting -...
How to Effectively Implement an Environmental Monitoring System Part 2: The Validation and Handover Process
How to Effectively Implement an Environmental Monitoring System Part 1: The Installation Process
Viable Sampling Vs. Nonviable Sampling
Does it matter what kind of particle exists in your cleanroom? Yes, it does! Two types of contamination include viable and nonviable particles. Depending on which is present in your cleanroom, you will be...
How Do You Measure Air Particles?
Air particles are measured by forcing air through a cavity in a particle counter which uses a laser to measure and count the particles. This is done through a process called light...
What Is An Ultrapure Water System?
Water is an extremely powerful force. We see it carve its way through land to form amazing geographical features like the Grand Canyon. So what can water do in your system? Ultrapure water systems clean water...
Cleanroom Classifications Explained
A cleanroom classification basically tells you how clean a cleanroom is. While we typically consider cleanrooms to use HEPA filters and multiple layers of protection, cleanrooms can really be any room where...
Particle Counting Fundamentals
What Are Particles?
Particles are all the physical little pieces of stuff floating around in the air. Sometimes they can be visible to the naked eye (like a large floating piece of dust or pollen), but, most of the time, when...
5 Fundamentals Of Particle Counters
Particle counters do just that: they count particles. They are used in cleanrooms to count and size the particles in the air so the cleanroom can stay in proper working function and meet crucial...
What is a Cleanroom?
Different Types of Contamination
Contamination in the cleanroom can lead to product quality and safety issues and must always be controlled. What are the most common types of contamination you can find in a cleanroom?
Indoor Air Quality And Particle Detection Methods
Indoor air quality is the air quality within and around buildings and structures. IAQ is known to affect the health, comfort and well-being of building occupants. Poor indoor air quality has been linked to...
Cleanroom Grades ABCD Explained
A clean room is an environment, typically used in manufacturing or scientific research that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors....
Basics of Particle Counting, Part 3
Understanding how a particle counter works can really assist in increasing your awareness regarding your environmental monitoring data. With particle counter technology sensitivity it is important to take...
Introduction to Particle Sizes
Basics of Particle Counting, Part 2
a particle counter is an instrument that detects and counts particles not visible to the naked eye. Airborne Particle Counters (APCs) specifically use light scattering techniques to count particles in an air...
Basics of Particle Counting, Part 1
Particle Counters have been around for many years and are used in many industries and they are an important tool for early fault diagnosis of a Cleanrooms air filtration integrity. In this guide, we will...
Introduction to Demarcation Lines in USP 797 Regulated Cleanroom Environments
Airborne Particle Deposition in Cleanrooms
Deposition Mechanisms Abstract This article discusses the mechanisms of particle deposition onto cleanroom surfaces. The main mechanism for particles above 0.5 µm is gravitational...
Continuous Particle Monitoring in Cleanrooms
In order to determine the best system for continuous monitoring of particles in a cleanroom, you should understand the two types of continuous particle monitoring systems. Real time particle monitoring...
Cleanroom Requirements, Certification and Monitoring Per Common Accepted Standards
Cleanroom Classification and class limits are established in ISO 14644-1 (see Table 1), while specifications for testing and monitoring to prove continued compliance are established in ISO 14644-2 (see Tables...
