Best Practices
49 Results
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...
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...
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...
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...


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


How to Effectively Implement an Environmental Monitoring System Part 2: The Validation and Handover Process


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


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...