Glossary
Sterile Product
For purposes of this guidance, sterile product refers to one or more of the…
Sterilizing grade filter
A filter that, when appropriately validated, will remove a defined microbial challenge from a…
SteriShield Delivery System
An effective cleaning and disinfection program in controlled areas is critical to maintain product…
Temperature & humidity control
Particle control and temperature and humidity performance need to be balanced in order to…
Terminal sterilization
The application of a lethal sterilizing agent to finished product within a sealed container…
The Federal Standard 209E
The Federal Standard 209E “Airborne Particulate Cleanliness Classes in Cleanrooms and Cleanzones” graded cleanrooms…
ULPA Filtration
An ULPA filter is a filter media which is efficient at removing submicron particles…
Unidirectional flow
Unidirectional Airflow and Laminar Flow Units In a laminar flow unit, clean air has…
User Requirement Specification (URS)
UV Lighting
To supplement standard cleanroom lighting, UV lamps and UV light equipment can be used…
Validation
Establishing documented evidence that provides a high degree of assurance that a specific process…
Vaporised Hydrogen Peroxide (VHP)
Vaporised hydrogen peroxide (VHP) has antimicrobial properties and so has decontamination and sterilisation applications,…