Isolator Airflow Visualisation: How to Plan and Judge a Smoke Study
How to plan, film and judge an airflow visualisation (smoke) study in an isolator, including interventions through gloves.
Isolators
Isolators
Isolators
Environmental Monitoring in Isolators: Particles, Viables and the VHP Problem
What to monitor in a Grade A isolator, where to place samplers, and how residual hydrogen peroxide can affect viable monitoring.
Isolators
How to Write an Isolator URS: Sections, Example Requirements and Common Gaps
A section-by-section structure for an isolator URS, with examples of testable requirements and the gaps that cause problems later.
Isolators
Isolator Glove Integrity Testing: Methods, Frequency and What to Do After a Breach
How isolator gloves are inspected and leak tested, how often, how VHP affects them, and how to handle a failed glove.
Isolators
Hydrogen Peroxide Uptake in Isolator Filling: Protecting Sensitive Products After VHP
Why residual H₂O₂ after an isolator VHP cycle can reach the product, which drugs are sensitive, and how to measure and reduce uptake.
Isolators
Isolator FAT and SAT: What to Check Before Shipment and on Site
What an isolator factory acceptance test and site acceptance test should cover, with a practical checklist and how both feed into IQ/OQ.