Critical Environments White Papers & Case Studies
-
Components Of An Effective Disinfectant Prequalification Strategy
1/24/2022
Cleaning procedures designed specifically to destroy microbial contaminants that may be present are an important component of any microbial control strategy.
-
Choose The Right Cleanroom Insulation To Cut Hazardous Particulate Emission
1/21/2022
This app note considers the issues and describes a test protocol developed to measure the particulate contribution of three types of insulation during typical cutting and fitting operations within a cleanroom.
-
A Review Of USP <1788> Methods For Determination Of Subvisible Particulate Matter
12/4/2021
A recent revision to the USP 1788 Methods for Determination of Subvisible Particulate Matter was published to aid in clarification and support of the information given in various chapters. With the advent of flow imaging technologies and new therapeutic protein solutions, the scope of the document was widened. Here we explore the applicability methods, particle count limits, test method influences and more.
-
Trend Analysis Of Total And Viable Particle Monitoring Data
10/26/2021
Routine review and analysis of environmental monitoring data for trends at an appropriate frequency is essential to aid in the interpretation of process stability and assess environmental control performance.
-
EU GMP Annex 1: Non-Viable Environmental And Process Monitoring
10/26/2021
This paper covers many of the new EU GMP Annex 1 topics including system design, monitoring, cleaning and disinfection, risk assessment, microflora, events and deviations.
-
Alarm Rationale For Continuous Particle Counting Systems
10/26/2021
Here we review the description of current good manufacturing practices (cGMPs) and how they can be applied to a continuous monitoring system installed within a facility.
-
Improved Viable Particle Discrimination With Real-Time Particle Counter
10/18/2021
A new algorithm developed by a real-time viable particle counter determines the viability of a particle based on its measured optical properties, improving the detection of microorganisms.
-
Condensation Control In Cleanroom Environments
9/28/2021
Condensation in clean manufacturing facilities can lead to contamination of the environment and compromise the quality of products being produced, so must be avoided.
-
COVID-19 Vaccine Manufacturer Selects Innovative Cleanroom Insulation
9/28/2021
A closed-cell clean technology insulation product designed specifically for use in cleanrooms, increased long-term cost-effectiveness and helped eliminate risk within a manufacturer's facilities.
-
Selecting The Most Suitable Particle Sample Point Locations In Your Cleanroom
5/14/2021
When considering where to place sample points for particle monitoring, whether it will be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.), the answer is not always straightforward. Here, we help to identify the considerations, establish the most suitable location for monitoring a process, and build a scientific rationale for that decision.