How To Develop and Document a Contamination Control Strategy
Your Contamination Control Strategy (CCS) is the foundation of your cleanroom. This is where you plan
March 22, 2023
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
Are you considering a new particle counter for your cleanroom? There are a number of options
Did you know that water might be clean enough to drink but not clean enough to
What Is Cleanroom Paper? [Case Study] Do you use print-outs in your cleanroom? What kind of
Water is an extremely powerful force. We see it carve its way through land to form
Contamination in pharmaceuticals can quickly turn into a nightmare with yield loss, recalls, bad press, and
As clean air experts, we talk a lot about making sure that the air in a
In the COVID-19 era, indoor air quality has become a hot button topic. There are a
March is Women’s History month: dedicated to recognizing the critical contributions of women throughout history. As
Handheld particle counters are just what it sounds like: particle counters that you can hold in
If you’re working for a company already using a cleanroom, you’re well aware of the benefits
Particle counters do just that: they count particles. They are used in cleanrooms to count and size the
The new Biotech Training Facility (BTF) is a state-of-the-art training center where students can learn how
Lighthouse Worldwide Solutions attended the Interphex Osaka Japan exhibition on February 24-26, 2016. The AC100 and
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