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, […]
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 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 […]
Introducing a groundbreaking revolution in the world of liquid particle counting, we are thrilled to announce the latest addition to the Vertex family of LWS liquid particle counters – the […]
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 […]
Air Sampler impaction technology has been around for decades. However, the d50 is a little known aspect of air sampler technology design and it plays a critical role in air […]
Introduction In the realm of pharmaceuticals, the pursuit of excellence in product quality is a never-ending journey. Governments and private industries have diligently crafted recommendations and regulations over the years, […]
Introduction Cleanrooms in the Pharmaceutical industry are sanctuaries of precision, where the highest standards of cleanliness are not just expected but demanded. A key player in the sterilization arsenal of […]
Introduction In the high-stakes realm of Pharmaceutical manufacturing, precision and adherence to stringent cleanliness standards are non-negotiable. Compressed gases are a staple in cleanroom environments, but they also present a […]
Introduction Airborne particle counters play a crucial role in ensuring the environmental integrity of pharmaceutical, bio-pharmaceutical, and radiopharmaceutical facilities worldwide. In an increasingly globalized pharmaceutical industry, cooperation and harmonization have become […]
Semiconductor manufacturing is a highly intricate process, comprising numerous steps and stages, with each one presenting the potential for contamination. Contamination in this context can be particularly costly, leading to […]
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 […]
Semiconductors are the backbone of our world and the technology that runs our lives, businesses, health systems, entertainment, and more. They do an incredible number of often unappreciated tasks from […]
Choosing a particle counter for semiconductor manufacturing is not a small decision. It is a massive investment that has ramifications throughout your systems and cleanroom. When you choose one, you […]
One of the most important things you can do during semiconductor manufacturing is practice proper risk mitigation to reduce contamination. Contamination puts semiconductors at serious risk. It can cause them […]
Quality control in semiconductor manufacturing is superficially simple: create consistent quality products. That statement is easy enough to say, but incredibly difficult to truly implement. Quality control involves an in […]
We talk a lot about data integrity, but what happens, in the real world, when US Food and Drug Administration (FDA) data integrity protocols are not met? In December, we […]
No one goes into medicine to cause harm. Doctors, nurses, techs, administrators, PAs, CNAs, and all other staff come together to bring life and give hope. Hospitals should be places […]
Qualification of Vertex50 to measure and detect ≥50nm trends in UPW systems The Vertex50 has TRUE sensitivity at 50nm has been qualified to measure and detect ≥50nm particles in Ultra-Pure […]
Lighthouse offers an opportunity to sample the contamination level in compressed gases. In the electronics industry as well as the Pharma industry contamination control of compressed gas has been getting […]
With the never ending shift towards continuous quality improvements within the manufacturing of pharmaceutical products it is worth looking at the current requirement of GMP and also 21CFR11 in the […]
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 is the biggest villain in the contamination control and cleanroom world? Particles. Contamination. This contamination can cause yield and financial loss, delays, frustration, and physical threats to the end […]
The following questions will help you ask the right questions when implementing a system thatadheres to 21CFR Part 11. It is important to satisfy the requirements of this FDA code […]
21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. […]
Vaporized Hydrogen Peroxide (VHP) is a powerful chemical used to sterilize surfaces andequipment in the cleanroom, specifically in the medical equipment and pharmaceuticalindustries. It can cause deterioration and breakdown of […]
Particle Counter management is a critical process in ensuring particle counter health and data integrity. The accuracy of the data from particle counters is critical in regulated industries. Particle Counters […]
Water is one of the major utilities used by the pharmaceutical industry. Different grades of water quality are required depending on the different pharmaceutical uses. Control of the quality of […]
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 […]
We are all too well aware of the adverse effects of particulate matter contamination within parenteral injectable pharmaceutical products and the consequences for patient safety. Here, particulate matter refers to […]
An Environmental Monitoring System (EMS) is very different from a Building Management System (BMS). A building management system (BMS), also known as a building automation system (BAS), is a computer-based […]
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 […]
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 […]
