Remote particle counters are fixed units installed right inside your cleanroom at critical locations. Unlike handheld instruments that operators carry from spot to spot every so often, remote counters can […]
After more than two decades, the world of cleanrooms just received a major refresh with the release of ISO 14644-5:2025. If you manage, audit, or simply work in controlled environments, […]
When it comes to maintaining the integrity of cleanroom environments, human contamination remains the single greatest threat. In a recent webinar featuring Patricia Sitek, a leading biotechnologist and cleanroom consultant, and […]
Ensuring Cleanliness and Product Quality Keeping precision parts free from contamination is crucial in industries like aerospace, automotive, semiconductors, and medical devices. Even the smallest particles can impact performance, reduce […]
In today’s world, precision and cleanliness are critical in industries like pharmaceuticals and biotechnology. Among the many tools used to maintain strict cleanliness standards, viable air samplers stand out as […]
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, […]
In 2024 our knowledge center webinar series provided a comprehensive exploration into the latest advancements and best practices in cleanroom monitoring and environmental control. Covering a wide array of topics, […]
Ultra Pure Water (UPW) is critical in industries where even the smallest impurities can have significant consequences. It is used in semiconductor manufacturing, pharmaceuticals, and high-end laboratories—applications that demand the […]
At Lighthouse Worldwide Solutions, we’re excited to introduce our latest innovation: the ActiveCount Remote Impactor Kit. This advanced system pairs the trusted performance of our ActiveCount25H or ActiveCount100H viable samplers […]
Liquid particle counting is essential for maintaining public health and safety by monitoring the purity and quality of liquids across various sectors, including drinking water, pharmaceuticals, and food production. This […]
It’s actually not as complicated as it might sound at first. Think of GAMP as your friendly neighborhood guide to making sure medicines are top-notch and safe for everyone. GAMP […]
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 […]
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 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 […]
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 […]
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 […]
Pharmaceutical injectable aseptic injections are essential medical products that are administered through injections, directly into the body. The manufacturing process for these injectable drugs is a meticulous endeavor, requiring stringent control measures […]
In the meticulous realm of pharmaceuticals and controlled environments, precision is paramount. Particle counters emerge as indispensable tools in maintaining stringent quality standards. This blog elucidates the critical role of […]
In the complex landscape of pharmaceutical manufacturing, where the safety and efficacy of medicinal products are paramount, Annex 1 of the EU Guidelines for Good Manufacturing Practice (GMP) for Medicinal […]
In our rapidly evolving world, environmental monitoring has become a critical aspect of safeguarding our planet’s health. From air and water quality to soil conditions and climate patterns, the data […]
In 2022, GMP Annex 1 was revised to reflect the changing landscape of technology, discoveries, best practices, and needs. At the time of publication, this is the first and only, […]
“Risk mitigation” is one of our favorite phrases. The best way to prevent yield loss, ensure end user safety, and high quality is to avoid risk from the beginning. What […]
We talk a lot about life cycles, but have you used this approach to implementing a new system, especially a large one, such as Real Time Monitoring System (RTMS)? If […]
GAMP5: another day, another acronym. So let’s break it down! GAMP5 stands for the Good Automated Manufacturing Practices 5th version. This publication is monitored by the GAMP committee of the […]
Good Automated Manufacturing Practices (GAMP) has been defining IT validation since 1991. Since then, it has gone through 5 revisions, the most recent of which was in 2008. This version […]
GAMP5 refers to the fifth publication of Good Automated Manufacturing Practices published by the International Society for Pharmaceutical Engineering (ISPE). GAMP5 is not a set of regulations, but instead a […]
Every revolution is, well, revolutionary. Processes and people massively change in a way that rocks the world to its core, in a way that makes it so the world is […]
ISPE’s Pharma 4.0 initiative points to everything the pharmaceutical industry could be if it embraced the same advancements of the fourth industrial revolution: digitization, empowerment, and automation. This is achieved […]
For years now, robots and automation have been making their way into pharmaceutical production. Lately, though, the power of Artificial Intelligence (AI) has taken the world by storm in the […]
A lot has changed since the 1700s in the whole world, but especially in the pharmaceutical industry. Over the past 250 years, four industrial revolutions have swept the world, drastically […]
You will hopefully not be shocked to learn that data integrity is an integral part of a properly running cleanroom. If this does come as a surprise to you, we […]
What is a foundational piece of your cleanroom contamination control strategy? Your gowning protocol. Humans, by far, produce the most particles in a cleanroom and your gowning protocol can limit […]
An active air sampler is one of the tools you can use in your cleanroom to monitor contamination, but, specifically, it is the tool you can use to monitor viable […]
Testing of compressed gases is a GMP requirement when such gases are used in cleanroom applications. It is critical for such testing to occur since product process zones in ISO […]
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 […]
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 […]
If you use compressed gasses in your cleanroom, ISO 8573 is an important set of guidelines and regulations for your cleanroom, specifically ISO 8573-1:2010. This set of guidelines is maintained […]
If you know us, then you know that clean air and water is our passion in life. But what happens when you cannot prove to the regulatory authorities that your […]
A PQ is a performance qualification which is conducted prior to a system becoming operational. The PQ tests the system to ensure it meets its operational objectives in a real […]
Did you know we start to mitigate risk in our lives as early as 6 months old? That’s right: at 6 months old, an infant can recognize a stranger and […]
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 […]
Anyone who has used an N95 face mask knows that they are far from comfortable: they pinch in all the wrong places, they fail fit tests, and they limit your […]
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 […]
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 […]
Air Sampler impaction technology has been around for decades. However the d50 is a little know aspect of air sampler technology design and it plays a critical role in air […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
Everyone with a cleanroom could use a particle counter, right? But which particle counter is right for you, and WHY is that particle counter a portable one? First and foremost, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
