FDA and EUA Performance Testing of Media Devices

Project Description

BUDGET APPROVED ($10,000 - $20,000)

Microbiology Laboratory needed for FDA and EUA Recovery Studies to determine the ability of media products to maintain viability of various strains of Gram positive aerobic and facultative anaerobic bacteria, and any applicable viruses
Test organisms:
Viruses:
Adenovirus
Cytomegalovirus (CMV)
Echovirus Type 30 (Echo 30)
Herpes Simplex Virus Type 1 (HSV1)
HSV2
Influenza A
Parainfluenza Type 3
Respiratory Syncytial Virus (RSV)
Varicella Zoster Virus (VZV)
Chlamydiae:
Chlamydia pneumoniae Strain CM-1
Chlamydia trachomatis Type 1 Strain UW-12/UR
Mycoplasma:
Mycoplasma hominis
Mycoplasma pneumoniae
Ureaplasma:
Ureaplasma urealyticum
COVID-19

Recovery Stability ? determine the ability to recover bacteria and viruses at
specified time intervals up to 13 months following date of manufacture
o pH stability
o Sterilization
ISO 11137: Sterilization of health care products ? Radiation

Biocompatibility
o ISO 10993: Biological Evaluation of Medical Devices (surface contact, <24hrs)
? Cytotoxicity
? Irritation
? Sensitization