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 efficiency in sterile manufacturing processes. 1. Human-Induced Contamination: Humans are significant producers of particles within cleanroom environments, shedding up to 40,000 skin cells per minute 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 operations. 1. Real-time Monitoring: Contamination is inevitable, but swift detection and response can mitigate its impact. Real-time monitoring and continuous microbial monitoring bridge the gap between data collection and analysis, […]
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 could lead to product shortages. Selecting the right environmental monitoring software and hardware is paramount to the success of your cleanroom operations. The software serves as the […]
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 highest quality of products. The advent of Pharma 4.0 has ushered in a new era of digital transformation, leveraging the power of the Internet of […]
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 integration of advanced features, has significantly improved compliance with stringent industry standards. In this blog, we delve into the intricacies of these advanced air […]
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 propel these vehicles. However, manufacturing lithium-ion batteries is a complex process that demands meticulous control over various factors, including particle contamination. Particle Contamination: A Hidden […]
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 risk of contamination during the manufacture of sterile products. This shift towards continuous EM requires manufacturers to adopt specific techniques and align their monitoring programs […]
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 plays a crucial role in contamination control strategies, ensuring that particulate contaminants are kept out of injectable pharmaceutical products and, ultimately, the bodies of end-users. […]
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 levels of water quality, making it essential to have precise control over water purification systems. Contaminated water can jeopardize product quality and, ultimately, patient safety. […]
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 and factors that go into making this decision, so where exactly should you start? Here at LWS, we specialize in helping manufacturers make educated decisions […]
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 System (EMS), though, can make it simpler. An EMS is made up of a system of filters and sensors that connect to a processing software. […]
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 following evidence-based best practices across the globe improves the world population’s health. Pharmacopeias work across borders to collaborate on best practices and knowledge, improve access […]
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 all elements of an industry for areas of advancement. One of the pillars of standards for the pharmaceutical industry is the United States Pharmacopeia. So […]
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 for every step along the drug development process. There are four stages to drug development: R&D, regulatory review, manufacturing and distribution, and medication use. This […]
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 and manufacturing processes. The USP-NF itself contains over 6,800 monographs for over-the-counter and prescription products, medical devices, supplements, and other related particles. It is revised […]
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 is equally important to study the topic in detail. Sections are listed below. 1. Effect on the cell 2. Sources of generation 3. Mitigation techniques We are going […]
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 not always be followed. While trying to save lives and stay afloat in the overwhelm, healthcare workers might slip up. They theoretically know and understand […]
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 concert. When you’re seated in a splash zone, you usually are supposed to wear some kind of poncho to serve as a barrier between you […]
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 Control and Prevention (CDC) reported that this alarming number of patients contract an HAI every year, totaling almost 2 billion nosocomial infections and 90,000 deaths […]
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 are applicable to anyone in healthcare who is responsible for receiving, preparing, administering, or transporting hazardous drugs. This guideline follows the National Institute for Occupational […]
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 specialized medication? Or have to take multiple medications? The answer for you and your pet might be compounded drugs! Compounded medications are prescribed by your […]
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 under strict contamination control protocols, but do you know why? As the world’s clean air experts, we’re here to help explain exactly what’s going on […]
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 sent and are readily available throughout the United States. There are roughly 56,000 community pharmacies in the states, but only 7,500 of those specialize in […]
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 options, and smart batteries. Now, as 2022 comes to a close, we want to consider how these trends have played out in the last year […]
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 still burned more than 6.7 million acres. While thousands of people lost their homes, almost every resident of the state was able to see the […]
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 use and reliability. You should be able to trust that your airborne particle counter is working for you and not the other way around. You […]
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 precautions are taken to ensure that the product stays clean from contaminants. But if that’s the case, then what makes one cleanroom stand […]
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 of cleanliness depending on the cleanroom’s classification and application. Those criteria extend to the compressed gasses used in cleanrooms, as well, like oxygen, hydrogen, methane, […]
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 revolution. It encapsulates the changes we are seeing happen in the world because of the internet. Pharma 4.0 is ISPE’s roadmap for pharmaceutical companies to also […]
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 your porch, enjoying a hot coffee as the weather turns brisk… And the first snowflake of the year falls. How exciting! This is your first […]
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 and advertising of different purified water brands. What does it bring to mind? For many of us, a phrase we learned long ago in high […]
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. But to the everyday consumer, products being free from contamination is often taken for granted. We often don’t even think about contamination control! For many, […]
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 pharmaceuticals and as a chisel for semiconductors. While it has many other purposes, these are the primary two. And those two industries use a lot […]
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 of particles in a sample of ultrapure water used in cleanrooms. Ultrapure water is water that has been specially processed to minimize contamination. It is […]
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 different countries met to discuss its future the previous year. They saw the need for a non-governmental body whose sole job it was to determine […]
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 system. These are systems that monitor your cleanroom for particle contamination in real time. They provide continuous monitoring, alarms, and feedback for your team. The […]
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 2018, a NASA cleanroom was contaminated with fungi. While the fungi was found around the cleanroom, it was heavily concentrated around a filter that had been installed […]
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 is, “A system for producing quality equipment using the concept of prospective validation following a life cycle model. Specifically designed to aid suppliers and users […]
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 components of a cleanroom are what keeps the cleanroom clean. To control contamination in a cleanroom clean air is required, access is limited and outside […]
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! Depending on your filter and application, there are different cleanroom particle filtration techniques. Today, we’ll be covering 4 of them. Straining/Sieving This technique 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 place during the planning and building of a cleanroom because it has a lot to do with infrastructure. But understanding your cleanroom’s air distribution strategy […]
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 end-user. Most importantly, the filters’ MPPS defines your cleanroom’s potential classification. This classification limits your cleanroom’s applications. Cleanroom filtration is defined by the type of […]
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 particles are essential for optimum operational performance.
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 about it in different ways and report different data. According to ISO 14644, both are acceptable forms of testing for classification, especially […]
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 to get as close as possible to it. Not only will operating your cleanroom by these “nearly perfect” standards keep your data in line for […]
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 risk to the contents of the cleanroom and, in some industries, a threat to the end-user or product. But we […]
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 address these needs. GAMP (Good Automated Manufacturing Practices) is a system designed specifically for suppliers and users in pharmaceuticals. GAMP certifies a system that produces quality […]
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 Counter sampling at a defined volume at evenly spaced test locations around the cleanroom based on current Cleanroom Standards. The most accepted and widely used […]
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. The International Standards for Organization (ISO) is one organization that sets cleanroom classifications. ISO is a non-governmental agency that sets standards in a number of industries. These […]
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 cannot attain the classification without first making sure your cleanroom is really that clean. You do this through a proper cleanroom contamination control strategy […]
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 why it is vital we prevent contamination at the source: in the cleanroom during the manufacturing of the pharmaceuticals. This involves utilizing a liquid particle counter […]
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 ultrapure water is not subject to testing or batch-lot release before use and is drawn from on-demand systems. Additionally, results from water testing are not […]
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 – especially as part of the product, such as in injectables and other pharmaceuticals – it needs to be purified. We’ve […]
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 longer airborne? That is what we call particle deposition. When a particle deposits, it causes contamination and chaos in a cleanroom. So it is important […]
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 it! This means that an effective EMS is able to recognize when things are going wrong. The cornerstone of this process is conducting a Performance […]
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 know it can be done right so at the end of the day you save time, money, and stress. Today, we’ve outlined the steps you […]
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 able to determine where your cleanroom contamination control strategy is suffering and how to build a cleaner cleanroom. To determine the […]
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 right! NASA uses cleanrooms – and quite often, too! Not only is their equipment highly tuned, so it needs to be manufactured in a clean […]
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. But something is being manufactured on our planet today that is genuinely indestructible. Plastic. That’s right: the plastic we are making today is here to […]
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 electronics that should be monitored to ensure the reported data is accurate. There are a few things you can look for in your particle counter […]
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, hospitals have been paying extra attention to their contamination control procedures. Aside from HEPA filters, hospitals have been using a piece of cleanroom technology to […]
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 following are considered general guidelines and best practices about what should not be allowed in a cleanroom. Street Clothes Your street clothes carry billions of […]
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 plastic, vinyl or clear flat materials. They offer many of the benefits of a permanent cleanroom, but with the added versatility of being movable and […]
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 scattering. Parts Of A Particle Counter Inside a particle counter, you will find a laser sensor block. This is where the particles are sized […]
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 healthcare facilities. Facility managers need to understand what components are needed for a monitoring program, but they must also ensure the data they produce is […]
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 through an airborne particle counter in real time. Today, it is used in the airborne particle counters that set industry standards, because it is the […]
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 time you really dove into your cleanroom contamination strategy? We highly recommend reviewing your strategy yearly to make sure you are still meeting industry best […]
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 each particle counter, we recommend you create a list of what you are looking for in your particle counter. On this list, we recommend you […]
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 manufacturing setting, it’s critical that the water is free of all contaminants and particles to maintain consumer safety. But what industries exactly need an ultrapure […]
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 think so. This is why we’ve started to investigate “cleanroom paper” and how this paper can impact the number of particles in a cleanroom while […]
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 – keeping it particle free – so it can be used to clean and etch in manufacturing, especially in […]
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 production in your cleanroom. Here at Lighthouse Worldwide Solutions – the world’s clean air experts – we’re pros at keeping cleanrooms extra clean. It’s our […]
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 Administration (FDA) Good Manufacturing Practices (GMPs) in pharmaceuticals and keep our products on the shelves and helping people. When we bring contaminants into a cleanroom, […]
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 one of the most surprising facts is that your indoor air quality was impacting you long before COVID. As the world’s clean air experts, we […]
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 air temperature and humidity. Handheld particle counters are a versatile, ergonomic tool that deserves its place in the modern cleanroom, along with indoor air quality […]
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 can improve your production, then a cleanroom might be the answer. Either way, a cleanroom is not a simple beast. It is a multi-layered room […]
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 certification criteria. The fundamentals of particle counters are relatively simple. You need to know how and why they work. If you have a […]
Abstract This article discusses the mechanisms of particle deposition onto cleanroom surfaces. The main mechanism for particles above 0.5 µm is gravitational settling. Turbulent deposition and electronstatic attraction can also occur at all particle sizes, and for particles below 0.5 µm Brownian diffusion is important.
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