Liquid particle counters are like silent guardians in industries where fluid purity is critical. From pharmaceuticals to water treatment and semiconductor manufacturing, these devices ensure that tiny, often invisible particles […]
Cleanrooms are essential controlled environments used in industries such as pharmaceuticals, biotechnology, and electronics manufacturing. Their primary purpose is to maintain high levels of cleanliness and minimize contamination, which is […]
Particle monitoring is like having a super-sensitive detective on your team, keeping an eye on invisible contaminants that could disrupt quality, safety, or efficiency. As industries evolve and regulations tighten, […]
Airborne Particle Counters (APCs) play a critical role in monitoring and maintaining the cleanliness of environments where air purity is essential, such as cleanrooms. There are two fundamental types of […]
In a cleanroom, even the smallest particle can pose significant risks. Particle deposition occurs when airborne particles come to rest on surfaces. Particle deposition in cleanrooms can compromise sensitive processes, […]
Ensuring that the equipment used within cleanrooms is easy to wipe down and free from particle contamination is vital. Poorly designed equipment can become a contamination source, which is ironic […]
Gas Sampling in Cleanrooms In cleanrooms, especially those classified ISO 5 or cleaner, maintaining contamination control is paramount. One significant potential source of contamination is compressed gas. Proper gas sampling […]
Overview Cleanrooms are essential in the pharmaceutical industry, providing controlled environments for the aseptic production of sterile products. Recently, big data analytics has emerged as a transformative tool, offering new […]
Understanding High Pressure Diffusers High Pressure Diffusers (HPDs) are essential for maintaining the precision of particle counts in compressed gas samples. They act as a link between the particle counter […]
Understanding High Pressure Diffusers High Pressure Diffusers (HPDs) play a crucial role in ensuring the accuracy of your particle counts when dealing with compressed gas samples. These devices serve as […]
As our world steadily moves towards a future dominated by electric vehicles (EVs), the safe and efficient manufacturing of EV batteries becomes increasingly critical. However, lurking within this crucial process […]
In the realm of cleanroom operations, humans are both a crucial asset and a potential source of contamination. Understanding and mitigating human factors are essential for maintaining optimal cleanliness and […]
In the meticulous world of cleanroom operations, efficiency isn’t just a goal—it’s a necessity. From real-time monitoring to paperless processes, here are three key strategies to elevate workflow and streamline […]
In the realm of sterile manufacturing processes, the Environmental Monitoring System (EMS) serves as a crucial barrier between success and potential disasters like system failures, product recalls, and contamination, which […]
In the rapidly evolving landscape of pharmaceutical manufacturing, the integration of cutting-edge technologies is not just a trend but a necessity to meet the stringent regulatory standards and ensure the […]
In the world of cleanrooms, where the highest standards of cleanliness and contamination control are paramount, air filtration systems play a pivotal role. The evolution of these systems, especially with […]
The rapid rise of electric vehicles (EVs) has brought about a surge in demand for high-quality lithium-ion batteries. These batteries are the heart of EVs, providing the power needed to […]
The 2022 update of the EU GMP Annex 1 has placed significant emphasis on the concept of continuous environmental monitoring (EM), highlighting it as a critical component in reducing the […]
Compliance with USP 788 standards doesn’t have to be a complex and laborious process. Recent advancements in liquid sampling technology have made achieving USP 788 compliance both simple and effective. Liquid sampling […]
Water quality plays a critical role in the pharmaceutical industry, where stringent requirements must be met to ensure the safety and efficacy of pharmaceutical products. Different pharmaceutical processes demand varying […]
Environmental Monitoring Systems (EMSs) are important and hefty investments that require typically large amounts of infrastructure; however, modern EMSs are becoming nimble, adaptable, and slimmer. There are so many options […]
Aseptic manufacturing is one of the most difficult forms of manufacturing. From the processes to the inspections to the documentation, this is not an easy task. The right Environmental Monitoring […]
At this point, we are no stranger to global health crises. But these crises extend outside of pandemics to regular everyday access to quality healthcare, as well. Standardization of care […]
In the wake of Pharma 4.0 – the term coined by ISPE to identify the fourth industrial revolution relationship with the pharmaceutical industry – it is critical to look at […]
The United States Pharmacopeia – National Formulary (USP-NF) is comprised of 6,800 monographs for over-the-counter and prescription products, medical devices, supplements, and other related particles and it is a resource […]
The United States Pharmacopeia – National Formulary (USP-NF) serves as a resource for drug manufacturers, researchers, and anyone else involved in the development of pharmaceuticals with quality standards for ingredients […]
The article is mainly focused on the impact, causes and reduction of particle generation during the manufacturing of Li-ion cells. Therefore, it is sub-divided into three sections as each aspect […]
It’s not a secret: PPE is important in every healthcare setting. But in the intensity of a hospital setting, amidst staffing shortages and sky-high hospitalization rates, proper PPE protocols might […]
Do you remember the last time you went to a show where there was a “splash zone”? Maybe it was a nautical show with seals or an art exhibit or […]
Did you know that approximately 1 out of every 31 hospital patients in the U.S. are expected to contract a Healthcare-Associated Infection (HAI)? That’s right – the Centers for Disease […]
USP <800> provides guidelines that “describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation.” These standards […]
Our furry family members sometimes go down for the count and need some medication to help pick them up. But what happens when they won’t take a pill? Or need […]
Whether you are a new compounding pharmacist or have been around for a while, you know that compound pharmacies are unique. In your workspace, you have to gown and operate […]
You probably don’t think of pharmacies as cleanrooms or controlled environments, but that’s because you are most likely thinking of community pharmacies! Community pharmacies are generally where generic prescriptions are […]
At the start of 2022, we outlined some trends we expected to see grow in popularity and necessity throughout the year. They included paperless cleanrooms, advanced self diagnostics, multiple transfer […]
During the 2020 fire season, more than 106 large wildfires occurred in the states of Oregon and California. The fires were battled by tens of thousands of wildland firefighters, but […]
An airborne particle counter only needs to know two things to begin sampling: where it is and how long to sample. From there, it should be built around ease of […]
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 […]
It is no mystery that cleanrooms need to be, well, clean. From the surfaces and tools to the air in the cleanroom, everything needs to remain at a certain level […]
Welcome to the age of the internet! Pharma 4.0 is the International Society for Pharmaceutical Engineering’s (ISPE) version of Industry 4.0, also called Smart Factory. Essentially, Industry 4.0 is the fourth industrial […]
What does your dream home look like? Maybe it’s a beautiful home way up in the mountains, where the air is fresh and the land is quiet. You sit on […]
If you are relatively new to the cleanroom world, you’ve probably heard the word “reverse osmosis” thrown around a few times. You might have also heard it used in marketing […]
We often throw around the word “contamination” and how dangerous it can be in a cleanroom. And if you work in or around cleanrooms, you know how true this is. […]
If you are working with a pharmaceutical or semiconductor manufacturing cleanroom, you most likely have seen ultrapure water in action. This water is used for water for injectables (WFI) in […]
If you have ever had a shot or used a cellphone, you have relied on a liquid particle counter! Liquid particle counters are used to measure the size and volume […]
ISO 14644 is a standard for cleanrooms that was developed by the International Standards for Organization (ISO). The ISO has been in existence since 1947, after 65 delegates from 25 […]
Is there a way that you can improve response times, decrease contamination delays, and reduce personnel frustration in your cleanroom? There absolutely is. The answer is a real time monitoring […]
Cleanroom maintenance is the key to ensuring your cleanroom continues to operate at peak form. Failure to conduct regular maintenance can have devastating consequences for your cleanroom. For instance, in […]
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. According to ISPE, GAMP […]
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 main […]
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 […]
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 […]
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 […]
Cleanrooms require air filters in order to trap contaminants from entering the cleanrooms air supply through its HVAC system. Cleanrooms are controlled environments where the control of temperature/humidity, pressure and […]
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, […]
What does a perfect cleanroom look like? Zero contamination, immaculately gowned personnel, and no malfunctioning equipment, ever. That’s the dream, right? While perfection might not be attainable, we can work […]
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 […]
In an ever changing world, we are constantly seeing new regulations and expectations. This is especially true in the area of computerized system compliance and validation. GAMP was designed to […]
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 Portable Particle […]
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 classification. […]
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 […]
What happens if an injectable is contaminated? Infections, complications, vein irritation, local tissue infarction, anaphylactic shock, other health risks, and potentially death… The end-user is put in jeopardy. That is […]
Water is an essential part of everyday life, and certain cleanrooms are no different – especially in pharmaceuticals. But water is unique apart from other products and process ingredients because […]
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 […]
As the world’s clean air experts, we talk a lot about monitoring your cleanroom’s cleanliness by keeping an eye on airborne particles. But what happens when airborne particles are no […]
Your Environmental Monitoring System (EMS): the frontline between your product and contamination. Or, at least, letting you know there is contamination so you can determine what the problem is and fix […]
Your Environmental Monitoring System stands between you and system failure, product recalls, contamination, and potential lawsuits. Sounds intense? We think so, too. But as the world’s clean air experts, we […]
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 […]
When we think of cleanrooms, we usually think of manufacturing, technology, food processing, research, etc. But have you considered how those processes are used by NASA for space exploration? That’s […]
What is something that is truly indestructible? Comic book fans will say a vibranium-metal alloy, while others might say that diamonds are about as close as we’ll get in reality. […]
Your particle counter is a foundational part of your cleanroom contamination control strategy, as it stands between you and contamination notification. But your particle counter has a wide array of […]
It’s no secret that COVID-19 has drastically impacted the world around us. Throughout August 2021, the illness has overrun hospitals. To combat the spread of COVID-19 amongst hospital staff and patients, […]
Cleanrooms are just that: clean. Therefore, there are strict requirements around what is allowed in a cleanroom and what is not. While exact guidelines might change in different cleanrooms, the […]
Looking for an affordable alternative to a permanent cleanroom? Portable cleanrooms (also called modular cleanrooms) are usually constructed with a rigid frame such as steel and have panels made from […]
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 […]
Features to look for in your particle monitor to ensure compliance of your cleanroom Environmental monitoring lies at the heart of regulatory compliance for cleanrooms used in pharmaceutical, bio-pharmaceutical, and […]
Light scattering is a technology that revolutionized the airborne particle counter industry, because it is able to quickly, efficiently, and accurately determine the size and number of particles that pass […]
Your cleanroom contamination control strategy is the frontline between you and contaminated products, which can lead to yield loss, slowed production, and possible reputation damage. So when was the last […]
Are you considering a new particle counter for your cleanroom? There are a number of options that might be right for you. Before reading through the pros and cons of […]
Did you know that water might be clean enough to drink but not clean enough to use in your food? When it comes to water used in a cleanroom and […]
What Is Cleanroom Paper? [Case Study] Do you use print-outs in your cleanroom? What kind of paper do you use? Could we be doing better than current industry standards? We […]
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 […]
Contamination in pharmaceuticals can quickly turn into a nightmare with yield loss, recalls, bad press, and harmed consumers. Thus, it’s critical to stop contamination from ever being an issue during […]
As clean air experts, we talk a lot about making sure that the air in a cleanroom stays as clean as possible. We do this to meet Food and Drug […]
In the COVID-19 era, indoor air quality has become a hot button topic. There are a lot of interesting facts about indoor air quality that you might not know, but […]
Handheld particle counters are just what it sounds like: particle counters that you can hold in your hand. They are typically use to spot check a cleanroom or to test […]
If you’re working for a company already using a cleanroom, you’re well aware of the benefits of a cleanroom and how important they are. But if you’re wondering how you […]
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 […]
