SAS 10 Flashcards
the classified part of a facility that includes the aseptic processing room and ANCILLARY classrooms.
Aseptic Manufacturing room
A building, or segregated segment of it, containing cleanrooms in which air supply, materials, and equipment are regulated to control microbial and particle contamination.
Aseptic processing Facility
A room designed, maintained, and controlled to prevent particle and microbiological contamination of drug products.
Cleanroom
An area designed to maintain sterility of sterile materials
Critical room
A process that eliminates viable bioburden via use of SPORCIDAL chemical agents.
Decontamination
A process by which surface bioburden is reduced to a safe level or eliminated.
Disinfection
A room in which one or more ASEPTIC ACTIVITIES or processes is performed.
Aseptic process room
ULPA meaning
Ultra-low Penetration Air filter
retains less than 0.3mm particle at 99.99 percent efficiency.
HEPA meaning
High efficiency particulate air
retains greater than 0.3mm particle at 99.97 percent efficiency.
HVAC meaning
Heating, Ventilation, Air conditioning
Test which may be PERFORMED DURING MANUFACTURE of either the drug substance or drug product
In-process test
this is used to evaluate and ensure the quality of in-process materials and/or final product based on process date
Real time release testing
these are checks performed during production in order to monitor the process and ensure that it conforms to the specification
In-process control
A system for designing, analyzing, and controlling, manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes
process analytical technology
this is designed to ensure that a product of required quality will be produced consistently
control strategy
