Best Practices
49 Results
Cleanroom Basics: What Is Ultrapure Water?
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...
Basics On Minimizing Contamination Risk In Your Cleanroom
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...
What is 21CFR11 and Why is It So Important To Data Integrity ?
Data integrity is ensuring the data you have is complete, accurate, and consistent. It is one of the most important factors in a cleanroom. The FDA outlines their data integrity expectations in 21CFR11...
What Is 21 CFR 11?
How much time do you spend each day hunting down signatures? Or do you get to use a digital system to endorse documents? If you get to record, verify, and store data digitally, you can thank 21 CFR...
Cleanroom Gowning Best Practices
Gowning is incredibly important in a cleanroom because the biggest source of contamination is you! The biggest source of contaminants, by far, is human personnel. Unlike inanimate objects, human beings...
Cleanroom Maintenance Checklist
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...
3 Automations To Improve Your Cleanroom Workflow
At the end of the day, in a cleanroom: time is money. Cleanrooms are expensive to operate and, while they are running, they have a lot to do. Technicians gown up and put their expertise to work on various...
Your Path To A Paperless Cleanroom Part 2
How To Improve Your Cleanroom Data Integrity What does particulate data collection in your cleanroom look like? Let’s paint a picture together of the current system - or close to it - in the...
Lighthouse Active Air Sampler Technology and d50
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 sample capture. Aerosol Impaction...
Lighthouse Apex Particle Counters compatibility with Vaporized Hydrogen Peroxide
Vaporized Hydrogen Peroxide (VHP) is a powerful chemical used to sterilize surfaces and equipment in the cleanroom, specifically in the medical equipment and pharmaceutical industries. It can cause...
Your Path To A Paperless Cleanroom part 1
Did you know 75% of life science companies still use a paper based system in their cleanrooms? That means in an 8 hour shift, you need someone to look at as much as 5,000 individual count data samples which...
The Selection of the right Air Sampling Equipment for Your Process and Quality Assurance
In our cleanrooms where sterile products are manufactured biocontamination needs to be controlled and monitored frequently and in risk zones continuously during production. The goal is to produce safe and...
Good Automated Manufacturing Practices 5 (GAMP5) And Your Cleanroom
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....
Fill the “GAP” Good Application Practice “How to Test HEPA Filters ”
Cleanroom Air Filters: Controlling Contamination in The Cleanroom
What is GAMP and why is it so important in Cleanroom Manufacturing?
Best Practices in Particle Counter Management To Increase Data Integrity Reliability
Good Automated Manufacturing Practices (GAMP) In A Cleanroom
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...
Your Guide To GMP Annex 1: Part 2
Welcome back to your guide to GMP Annex 1! Previously, we discussed how GMP Annex 1 defines and regulates cleanroom classification. In this article, we’re going to address how it defines and regulates...
Your Complete Guide To GMP Annex 1: Part 1
The GMP Annex 1 describes the best practices for classifying and monitoring your cleanroom and clean air equipment. In 2020, a new version was drafted with some changes and clarifications from the original...
How To Choose Your Cleanroom Classifying & Monitoring Tools
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...
Cleanroom Classification: What Makes A Cleanroom
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...
How to Effectively Implement an Environmental Monitoring System Part 2: The Validation and Handover Process
Choosing & Installing An Environmental Monitoring System
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...
How to Effectively Implement an Environmental Monitoring System Part 1: The Installation Process
How to validate your Cleanroom. HVAC Performance Qualification Basics.
Using a Risk Assessment to Build a Monitoring System Focusing on Data Integrity
10 Ways To Improve Your Cleanroom’s Gowning Protocols
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 that...
Foundations of a Cleanroom Contamination Control Strategy
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...
ISO 17025 Calibration
What It Means And Why It’s Important Lighthouse Worldwide Solutions is proud to announce that all of our manufacturing and service facilities have been accredited for the ISO 17025 testing and...
What Is Particle Counter Calibration? And why is it important?
What Is Particle Counter Calibration? And why is it important? Particle counters are a fundamental part of any properly maintained cleanroom. They are intricate tools used to count the number of...
Performance Qualification of Environmental Monitoring Systems
Particle Counting Sample Tubing Guidance and Best Practices
Airborne Particle Counters are used for a variety of purposes in pharmaceutical cleanrooms for such applications: Filter testing Cleanroom certification and testing Isolator certification and...
Particle Monitoring - Going Paperless in the Cleanroom
How to Perform a Performance Qualification On a Particle Monitoring System
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 world operational environment. It...
Selecting the Right Monitoring Instruments for Cleanroom Classification and Routine Reclassification Following current cGMP
One of the biggest challenges in any cleanroom is setting up a suitable environmental monitoring (EM) program. Which instruments are used for sampling, how frequent samples should be, how much sampling is...
Manifold Monitoring Systems Explained
Manifold systems have been used for many years in particle monitoring in controlled environments. A manifold system uses one particle counter and a mechanical system to align the sample inlet of the particle...
Cleanroom Gas Sampling Using a Particle Counter
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 5 cleanrooms and zones require...
Cleaning and wipedown best practices
Controlling cleanroom contamination is mission critical for sterile manufacturing processes. It is vital the equipment taken into the cleanroom and used in the cleanroom are easy to wipe down and keep free...
Cleanroom Gas Sampling Using an Active Air Sampler
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 5 cleanrooms and zones require...
Cleanroom Air Changes Best Practices
Cleanrooms are defined by their cleanliness level based on the absence of airborne particles present in a sample of a giving volume. ISO 14644-1 is an international standard for cleanroom classification....
Establishing a PHARMA Environmental Monitoring Program
"In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. The EM program provides meaningful information on the quality of the aseptic processing...
Particle Count Strategies on Alarm Settings
Setting inappropriate Alert and Action alarms on your Environmental Monitoring System (EMS) could be a big contributor to lost revenue, longer downtimes, and a lot of discarded products. Misinterpretation of...
Gas Sampling Applications
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...
Real Time Process Monitoring
A common approach to controlling contamination in high technology manufacturing cleanrooms is the continuous monitoring of particles. Either dedicated, discrete, “real-time” particle counters or a...
What do Particle Counts Mean?
When using particle counters, one needs to be aware of certain terms or phrases that are commonly used when describing functions of the instrument, or how the data is viewed and reported. Data are displayed...
Maintaining Validation and Calibration
A wide variety of scientific instruments are used on a regular basis to assist in our daily IAQ investigations. Moisture meters, temperature and relative humidity probes, infrared cameras, and particle...
Particle Transport in Tubing
Airborne Particle Counters (APC) are used for a variety of purposes such as: • Filter testing • Cleanroom certification and testing • Isolator and minienvironment testing and certification....
How to Select a Particle Counter for my Cleanroom
Often, the selection of a particle counter for use in a cleanroom is done based upon the specifications of the instrument and the purchase price. Before getting into the details of the specifications, it is...
