Sterility
During the 14 day routine inoculated sterility media checks. If you see growth what should you do?
Immediately call quality.
Regarding Environmental (EM) Testing, what does TNTC stand for?
Too Numerous To Count.
When performing the TLC test for the FDG final product, what QC dilution will be used to spot the TLC Silica Gel strip?
Any dilution that will result in Valid Total Region Counts.
Regarding glassware cleaning, if you are unable to immediately clean the glassware what MUST you do?
Fill with HPLC Water or SWFI and soak until can be cleaned.
It is acceptable to use expired chemicals in production and cleaning.
No
Does a user who will inoculate sterility media must first be fully qualified prior to performing inoculations on drug products?
Yes
During the course of a normal week, what 2 types of EM Agar Media will be used to test a PETNET facility?
Tryptic Soy Agar (TSA) and Sabrouraud Dextrose Agar (SDA)
Which of the following is the Mobile Phase (Carrier Gas) for the GC system?
Helium
Regarding glassware cleaning, if residue has settled onto your glassware which of the following can be used to remove it?
Weak acid or a Weak base.
Which statement best describes how to properly perform a data correction on a written form?
Draw one line through the incorrect data so as to not occlude the entry, Enter the new data beside the documented entry, sign & date.
Does the incubation for sterility media begins when the media is placed into the incubator ovens.
Yes
How long should the TSA plate be open during the daily EM monitoring of the ISO-5 area of the Hot Cell?
Minimum of 15 minutes
What is the purpose of Hydrogen gas in the GC system?
Fuel for the FID flame.
Can you use antimicrobial soap and water to appropriately clean reusable glassware?
No
What does the abbreviation PET mean?
Positron Emission Tomography
When preparing the sterility vials, which statement best describes the cleaning process?
In the designated area, spray with appropriate disinfectant, verify wet for minimum number of minutes.
How often is routine fungal EM testing performed?
Weekly
Which statement best describes the detector used in GC analysis?
Flame Ionization Detector (FID).
Why are sterility media negative controls used in our process for Sterility Testing.
One TSB and one FTM that will not be inoculated and will be used for visual comparison during the incubation phase.
In weekly cleaning of the LFH, how long must sporicidal disinfectant remain in contact with surfaces?
Minimum 10 minutes
Which type of solid media is specifically used to test for Kryptofix in the FDG final drug product?
Aluminum Oxide
During formulation of the FDG final product vial, what 3 liquids are added across the sterilizing filter?
Sodium chloride, 200 proof ethanol, and SWFI