Featured Articles
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ISO/DTR 14644 -21 Cleanrooms And Associated Controlled Environments
2/22/2024
Here, we review the Technical Report outlining how particle counters are used to classify and monitor cleanroom performance, ensuring it meets required standards under normal operating conditions.
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Designing An Environmental Monitoring Solution For cGMP Manufacturing
3/13/2023
Environmental monitoring in cleanrooms should be performed using suitable techniques that meet the needs of the risk assessment. Learn about the requirements, typical instrumentation features, and more.
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Environmental Monitoring Handbook For Pharmaceutical Manufacturers
12/2/2022
Acquire a thorough understanding of environmental monitoring, covering the fundamentals of particle counting and cleanroom designs, regulatory expectations regarding market release, and more.
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Review Of Annex 1 2022: Environmental Monitoring Changes
9/13/2022
We highlight the changes to the new revision of the EU GMP Annex 1 regulatory standard for sterile drug products that was released in August 2022.
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Risk Assessment As A Process Quality Assurance Tool
8/12/2022
Discover how an effective approach to risk management can further ensure the delivery of a high-quality drug or medicine to the patient.
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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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USP <1788> Methods For Determination Of Subvisible Particulate Matter Revision Overview FAQs
2/26/2022
Thoughtful questions regarding how the USP <1788> revision expands the scope of testing requirements to include newly viable technologies such as flow imaging and new therapeutic protein solutions.
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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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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.