Best Practices
18 Results
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...
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...
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...
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
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...
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...
