Insights On Critical Environments
-
Expert Approaches To Pharmaceutical Containment Design And Facility Integration
4/18/2023
Review the process requirements, workflows, and process interventions that are key to your containment isolators achieving compliance with both cGMP and BSL-3.
-
Understanding The Importance Of Powder & Vapor Containment
6/14/2023
Have you considered the safety of your work environment’s air? Across industries, employers are determining how to detect inhalation hazards and, if present, how to protect employees from them.
-
Addressing Rapid Biomanufacturing Capacity Needs
10/21/2022
Adapt to evolving biomanufacturing demands and rapid capacity needs with a KUBio™ box environment, KUBio™ modular facility and integrated FlexFactory™ configurable manufacturing train.
-
Best Practices For Sterile Fill Operator Gowning Training
4/17/2023
Sterile fill operators are crucial in ensuring pharmaceutical products are contaminant-free and safe for use. Explore best practices for sterile fill operator gowning training, mobile cleanroom benefits, and more.
-
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.
-
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.
-
Process Control And Performance Of A Virus Filtration System
1/12/2023
Discover a single-use automated filtration system designed to deliver robust process control and integrity assurance during the critical purification step. Explore its design features, processing control, and more.
-
Presaturated Wipes: Ensuring Consistent Processes And Higher Quality
12/8/2022
Cleaning surfaces and equipment in controlled environments have historically involved a variety of methods. Explore key takeaways from studies regarding surface cleanliness and the benefits of presaturated wipes.
-
Tips For Successfully Scaling Your cGMP Manufacturing
6/23/2022
What are the specific obstacles to expanding manufacturing capacity? Cell therapy industry leaders share what to look for in a solutions provider and recommendations for navigating your road ahead.
-
Aseptic Sampling Devices In A Bioburden Reduction Strategy
8/31/2022
This paper delves deeper into aseptic sampling devices to explain how they offer exceptional performance in the effort to control contamination.