Sample Pharmacy Personnel/Processsampling Log Page 2 of 2

Sample Pharmacy Personnel/ProcessSampling Log Page 2 of 2

Name Compounding Employee/Process Verification: ______Sampling Date: ______

Gloved Thumb Fingertip Sampling: Initial and Ongoing

Plates pulled by: ______

Manufacturer: ______Lot Number: ______Expiration Date: ______

Action Level Designation Depends on Location of GFS:

Immediately after donning sterile gloves & before sIPA (Action Level: 0 CFUs): Ante-area CAI1 CAI2 CACI1 CACI2

During compounding in PEC (Action Level >3 CFUs): LAFW1 LAFW2 LAFW3 LAFW4 CAI1 CAI2 CACI1 CACI2

Time in Incubator: _____ AM/PM  May be read in 48 hours (date: _____/time:___AM/PM) but must be read within 72 hours (date: ____/time: ____AM/PM)

# CFU
Plate 1 (left hand) / # CFU
Plate 2 (right hand) / Total CFUs = Both Plates / Action Level Both Plates**
(see above) / Date/Time
Removed and Read / Signature Person Reading Plates
Initial > 0 CFUs
Ongoing > 3 CFUs

** If CFUs exceed action level, notify manager. Minimum response must include review and documentation of hand hygiene, garbing, glove and surface disinfection and aseptic work practices.

Surface Sampling Associated with Employee

Check Type Plate/s Used: TSA (general growth media) MEA/SDA (fungal-specific media) Time in Incubator: _____ AM/PM

Plate/s pulled by: ______

Manufacturer / Lot # / Expiration Date / Incubation conditions
General Media: / 30-35°C for 48-72 hours
Fungal Specific Media: / 26-30°C for 5-7 days

Taken during compounding in PEC (Action Level >3 CFUs): LAFW1 LAFW2 LAFW3 LAFW4 CAI1 CAI2 CACI1 CACI2

Plate Type / #CFU per plate / Alert/Action Level
in ISO Class 5 Air / Date/Time
Removed and Read / Signature Person Reading Plates
General Growth Plate (TSA) / Alert Level > 1 CFU
Action Level > 3 CFUs
Fungal-Specific
MEA/SDA

** If CFUs exceed action level, notify manager. Minimum response must include review and documentation of hand hygiene, garbing, glove and surface disinfection and aseptic work practices.

Aseptic Media-Fill Testing

Description of Media Supplies* / Manufacturer / Lot # / Expiration Date

*may represent sterile or nonsterile, liquid or powdered TSB based on specific MFU procedure

Bag # /

PEC #

Days of Inspection

Results

/ Initials of Reader /

Date

1 / 2 / 3 / 4 / 5 / 6 / 7 / 8 / 9 / 10 / 11 / 12 / 13 / 14 / Pass / Fail

Incubate at 20 -35° Celsius

If bag is clear, initial box on day of inspection BUT if bag is cloudy, mark an X in the box & line out remaining days. Indicate “FAIL” in space provided and notify Pharmacy Manager.

______Signature of Pharmacy Manager after document review Date

Portions of this information and these forms are proprietary to, and subject to copyright ownership of, Clinical IQ, LLC and have been modified by [Sample Pharmacy] under license and for limited use.