Fill & Finish
Location of first sterility isolator
Building 81, room 149
QC Micro Safety Rep
Colton Freeman
The most commonly recovered organism at Rensselaer IOPS in 2018
Micrococcus luteus
Process Areas responsible for component manufacturing and formulation of Eylea
PA5 and PA2X
Target closure date of an NOE investigation
5 business days
Number of filling lines that are being constructed at Tempel Lane?
Three
Equipment worn to minimize exposure to hazards
PPE
(Personal Protective Equipment)
A thin slimy film of bacteria that adheres to a surface
Biofilm
Name any chromatography step
affinity, ion exchange, hydrophobic interaction, size exclusion
Organism identified in PA2X EOE which launched months of investigational RODAC sampling
Chaetomium globosum
Acronym for the airlock on the isolator
SARA
(Safe And Rapid material Airlock)
Agency of the U.S. government responsible for ensuring safety at work and a healthful work environment
OSHA
(Occupational Safety and Health Administration)
A bacterium, virus, or other microorganism that can cause disease
Pathogen
Meaning of "SUB" in process area names PA2SUB and PA3SUB
Single Use Bioreactor
Consumable implicated in In-Process endotoxin recoveries in 2019
50mL conical tubes
Regulatory guidance for sterility testing
USP <71>
Designing or performing your work tasks so they are safe and comfortable to carry out
Ergonomics
Facultative anaerobic endospore-forming bacteria typically observed as a spreader on agar
Paenibacillus
Y-shaped proteins produced by the human body, as part of a normal immune response to foreign molecules
Antibody
Type of filter used in Harvest process which was implicated in harvest sample endotoxin recoveries
DE filters
(Diatomaceous earth)
Assay that evaluates the adequacy of container closure systems to maintain a sterile barrier against potential contaminants
Container Closure Integrity (CCI) testing
Internal portal to request PPE
Safety Shed
The Gram reaction of the top 8 bacterial species recovered at Rensselaer IOPS in 2018
Gram-positive
Solution retained by the membrane following the tangential flow filtration of UF/DF
Retentate
Contract laboratory with recent sterility failures
Nelson