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
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...
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...