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Best Practices

16 Results
Apr 21, 2022

Best Practices in Particle Counter Management To Increase Data Integrity Reliability

Good Automated Manufacturing Practices (GAMP) In A Cleanroom Small Image
Mar 30, 2022

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 Small Image
Mar 1, 2022

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...

Dec 15, 2021

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

Choosing & Installing An Environmental Monitoring System Small Image
Nov 29, 2021

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...

Nov 24, 2021

How to Effectively Implement an Environmental Monitoring System Part 1: The Installation Process

Sep 22, 2021

How to validate your Cleanroom. HVAC Performance Qualification Basics.

Jun 29, 2021

Using a Risk Assessment to Build a Monitoring System Focusing on Data Integrity

Jul 22, 2020

Performance Qualification of Environmental Monitoring Systems

Apr 16, 2020

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...

Apr 15, 2020

Particle Monitoring - Going Paperless in the Cleanroom

Jan 15, 2020

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...

Oct 25, 2019

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...

Jan 24, 2019

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...

Jan 1, 2019

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...

Apr 1, 2017

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...