Pharmaceutical injectable aseptic injections are essential medical products that are administered through injections, directly into the
In the meticulous realm of pharmaceuticals and controlled environments, precision is paramount. Particle counters emerge as
In the complex landscape of pharmaceutical manufacturing, where the safety and efficacy of medicinal products are
In our rapidly evolving world, environmental monitoring has become a critical aspect of safeguarding our planet’s
In 2022, GMP Annex 1 was revised to reflect the changing landscape of technology, discoveries, best
“Risk mitigation” is one of our favorite phrases. The best way to prevent yield loss, ensure
Environmental Monitoring Systems (EMSs) are important and hefty investments that require typically large amounts of infrastructure;
Aseptic manufacturing is one of the most difficult forms of manufacturing. From the processes to the
Semiconductors are the backbone of our world and the technology that runs our lives, businesses, health
Choosing a particle counter for semiconductor manufacturing is not a small decision. It is a massive
One of the most important things you can do during semiconductor manufacturing is practice proper risk
Quality control in semiconductor manufacturing is superficially simple: create consistent quality products. That statement is easy
Lighthouse Worldwide Solutions, a renowned global leader in the manufacturing of cutting-edge contamination control equipment, is
We talk a lot about life cycles, but have you used this approach to implementing a
GAMP5: another day, another acronym. So let’s break it down! GAMP5 stands for the Good Automated
Good Automated Manufacturing Practices (GAMP) has been defining IT validation since 1991. Since then, it has
GAMP5 refers to the fifth publication of Good Automated Manufacturing Practices published by the International Society
At this point, we are no stranger to global health crises. But these crises extend outside
In the wake of Pharma 4.0 – the term coined by ISPE to identify the fourth
The United States Pharmacopeia – National Formulary (USP-NF) is comprised of 6,800 monographs for over-the-counter and
The United States Pharmacopeia – National Formulary (USP-NF) serves as a resource for drug manufacturers, researchers,
The article is mainly focused on the impact, causes and reduction of particle generation during the
Every revolution is, well, revolutionary. Processes and people massively change in a way that rocks the
ISPE’s Pharma 4.0 initiative points to everything the pharmaceutical industry could be if it embraced the
For years now, robots and automation have been making their way into pharmaceutical production. Lately, though,
A lot has changed since the 1700s in the whole world, but especially in the pharmaceutical
Your Contamination Control Strategy (CCS) is the foundation of your cleanroom. This is where you plan
The European Union (EU) Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use
We talk a lot about data integrity, but what happens, in the real world, when US
It’s not a secret: PPE is important in every healthcare setting. But in the intensity of
Do you remember the last time you went to a show where there was a “splash
No one goes into medicine to cause harm. Doctors, nurses, techs, administrators, PAs, CNAs, and all
Did you know that approximately 1 out of every 31 hospital patients in the U.S. are
USP <800> provides guidelines that “describes requirements including responsibilities of personnel handling hazardous drugs; facility and
Our furry family members sometimes go down for the count and need some medication to help
Whether you are a new compounding pharmacist or have been around for a while, you know
You probably don’t think of pharmacies as cleanrooms or controlled environments, but that’s because you are
In 2020, a vote found EN ISO 14698 no longer suitable for use in Europe, and,
After 17 years of no revisions, a formal vote in 2019 replaced EN ISO 14698 with
You will hopefully not be shocked to learn that data integrity is an integral part of
At the start of 2022, we outlined some trends we expected to see grow in popularity
Have you ever heard the old wives’ tale that if you water your garden at night,
During the 2020 fire season, more than 106 large wildfires occurred in the states of Oregon
EN 17141 Cleanrooms and controlled environments – Biocontamination control is a relatively new European standard, introduced
An airborne particle counter only needs to know two things to begin sampling: where it is
What is a foundational piece of your cleanroom contamination control strategy? Your gowning protocol. Humans, by
An active air sampler is one of the tools you can use in your cleanroom to
This year, Lighthouse Worldwide Solutions is celebrating its 40th anniversary. Over the last 40 years, we
In 2017, GMP released a draft update to Annex 1, which received a lot of feedback.
A cleanroom classification basically tells you how clean a cleanroom is. While we typically consider cleanrooms
The European Union (EU) Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use
It is no mystery that cleanrooms need to be, well, clean. From the surfaces and tools
If you use compressed gasses in your cleanroom, ISO 8573 is an important set of guidelines
If you know us, then you know that clean air and water is our passion in
Welcome to the age of the internet! Pharma 4.0 is the International Society for Pharmaceutical Engineering’s (ISPE) version
Did you know we start to mitigate risk in our lives as early as 6 months
What does your dream home look like? Maybe it’s a beautiful home way up in the
If you are relatively new to the cleanroom world, you’ve probably heard the word “reverse osmosis”
We often throw around the word “contamination” and how dangerous it can be in a cleanroom.
If you are working with a pharmaceutical or semiconductor manufacturing cleanroom, you most likely have seen
Anyone who has used an N95 face mask knows that they are far from comfortable: they
If you have ever had a shot or used a cellphone, you have relied on a
ISO 14644 is a standard for cleanrooms that was developed by the International Standards for Organization
What is the biggest villain in the contamination control and cleanroom world? Particles. Contamination. This contamination
Is there a way that you can improve response times, decrease contamination delays, and reduce personnel
Cleanroom maintenance is the key to ensuring your cleanroom continues to operate at peak form. Failure
At the end of the day, in a cleanroom: time is money. Cleanrooms are expensive to
The Good Automated Manufacturing Practices (GAMP) were developed by the International Society for Pharmaceutical Engineering (ISPE)
How many times have you heard us say, “your cleanroom filtration is critical”? Probably more than
We talk a lot about contamination control strategies in a cleanroom, but there is another type
Your filters are what separates your cleanroom from just some ordinary, run-of-the-mill room. They stop potentially
When you need to classify your cleanroom, do you reach for your trusty photometer or particle
What does a perfect cleanroom look like? Zero contamination, immaculately gowned personnel, and no malfunctioning equipment,
Does it matter what kind of particles exist in your cleanroom? Isn’t all contamination bad? On
In an ever changing world, we are constantly seeing new regulations and expectations. This is especially
So you’re going to classify your cleanroom. But what cleanroom classifying tools can you use that
So what exactly makes a cleanroom… A cleanroom? First and foremost, a cleanroom needs to be
What happens if an injectable is contaminated? Infections, complications, vein irritation, local tissue infarction, anaphylactic shock,
Water is an essential part of everyday life, and certain cleanrooms are no different – especially
Water. It makes up 70% of our bodies, but, even more importantly, it serves as a
As the world’s clean air experts, we talk a lot about monitoring your cleanroom’s cleanliness by
Everyone with a cleanroom could use a particle counter, right? But which particle counter is right
How It’s Made: Electric Vehicle Batteries Myth or truth: electric vehicle batteries are just as bad
Your Environmental Monitoring System (EMS): the frontline between your product and contamination. Or, at least, letting you
Your Environmental Monitoring System stands between you and system failure, product recalls, contamination, and potential lawsuits.
Imagine you’ve been rear-ended. There’s a little dent in your fender, but the paint has been
Does it matter what kind of particle exists in your cleanroom? Yes, it does! Two types
When we think of cleanrooms, we usually think of manufacturing, technology, food processing, research, etc. But
In many industries, face masks have played a significant role for many years! Surgeons wear them
What is something that is truly indestructible? Comic book fans will say a vibranium-metal alloy, while
Your particle counter is a foundational part of your cleanroom contamination control strategy, as it stands
It’s no secret that COVID-19 has drastically impacted the world around us. Throughout August 2021, the
Southern Oregon Air Quality: Introducing Rogue Valley Breathe Easy Here in Southern Oregon, air quality is
Cleanrooms are just that: clean. Therefore, there are strict requirements around what is allowed in a
Looking for an affordable alternative to a permanent cleanroom? Portable cleanrooms (also called modular cleanrooms) are
Air particles are measured by forcing air through a cavity in a particle counter which uses a
Features to look for in your particle monitor to ensure compliance of your cleanroom Environmental monitoring
Good Manufacturing Practices (GMPs – sometimes referred to as Current Good Manufacturing Practices or CGMPs) are federal
Light scattering is a technology that revolutionized the airborne particle counter industry, because it is able
Your cleanroom contamination control strategy is the frontline between you and contaminated products, which can lead
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