Critical Environments White Papers & Case Studies
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Proper Biological Indicator Placement During Vaporized Hydrogen Peroxide Decontamination Cycles
4/20/2022
We discuss the three general BI types used for monitoring the VH2O2 cycles and directions on their proper placement in the isolator.
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Using Replicate BIs To Evaluate Biodecontamination Cycles In Isolators
4/20/2022
We discuss the concept of using triplicate biological indicators (BIs), not as a reaction to having obtained an unexpected growth-positive BI in your vaopr hydrogen peroxide cycle, but as a proactive measure.
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Parameters Affecting Vapor Hydrogen Peroxide Biological Indicator Performance
4/20/2022
We review the potential benefits and difficulties of using Vapor Hydrogen Peroxide (VHP) in decontamination and sterilization.
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A New Challenge For Quality Experts – The Data Quality Concept
4/20/2022
Quality experts are facing the challenge of rethinking their roles and redesigning the quality systems of their pharmaceutical companies to be based on the concepts of data quality.
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Moisture And Microbial Resistance And cGMP In Pharmaceutical Facilities
3/21/2022
The material and design of your insulation material should consist of material that provides a good barrier for moisture penetration in order to maintain its effectiveness and avoid microbial growth.
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Pharma Manufacturing: Effect Of Insulation Coverage On Energy Savings
3/21/2022
It is more important to ensure maximum coverage of pipework with insulation than it is to insulate easy-to-reach portions of piping with very thick insulation, leaving some pipework bare.
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Study Of Single Use Device Media Dehydration And Biological Recovery Efficiency
2/26/2022
In this study, we review the performance of collecting contamination from continuous three-hour samplings using the BioCapt® Single-Use under unidirectional airflow, at 22 °C with 48% relative humidity.
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An Analysis Of Acceptable Particle Losses In Tubing
2/1/2022
This paper addresses the various forces, the losses, and what are the acceptable results to allow for a better understanding what is acceptable particle loss in tubing.
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Amorphous Formulations For Insoluble Drugs: Rational Design & Practical Approaches On Formulation Screening & Development
1/26/2022
The issues associated with amorphous formulations include solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, in vitro in vivo performance, process and scale-up.
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Formulation Development From Preclinical To First-In-Human
1/24/2022
A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.