Filling
Specific procedures performed under carefully controlled conditions with the goal of minimizing cross-contamination
Aseptic Techniques
The personnel responsible for sanitizing totes
Documenter
The process of transferring an item from a lower classification environment to a higher classifcation
Material Transfer
The number of hits allowed for a gown certification
0
The negative weight of an empty IV bag
Tare Weight
An area which comes in direct contact with sterile product
Critical Site
The personnel responsible for performing syringe attribute inspections
QA
The equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses
PPE
The use of air samplers to detect microorganisms in a classified environment
Viable Air Sampling
A sterilization process by which the drug product is sterilized in its final closed container
Terminal Sterilization
The area, equipment, or device in which direct aseptic manipulations are performed
PEC
The personnel in charge of the cleanroom
Documenter and QA
An agent that destroys bacterial and fungal spores when used in sufficient concentration for a specified contact time
Sporicidal Agent
0 for ISO-5, 3 for ISO-7
Glove CFU Recovery Limit
The user interface that connects an operator to the controller for a machine
HMI
A luer-lock to luer-lock connector used to transfer fluid from one container to another
Rapid Fill
Filler
The next step in the gowning process after donning and sanitizing sterile gloves
Sanitize the glove-donning table
This procedure number describes the traditional method and frequency by which Microbiology personnel perform environmental and personnel monitoring sampling
SOP-SC-MB-4511
The date and time after which a sterile product should no longer be used, stored, or transported
Beyond Use Date
The time in which autoclaved components must be installed in an ISO-5 environment
Clean Hold Time
The term for a room outside of an ISO-5 suite
Buffer Room
0 for ISO-5 and 5 for ISO-7
Sleeve CFU Recovery Limit
An area that utilizes HEPA filters to maintain cleanliness levels of a maximum of 10000 particles per cubic foot
ISO-7