Sterility Testing for Cell Lines, Cell Culture Media, and other Biological Material

Profile 1 – Direct Inoculation 

Direct inoculation on a battery of eight media, incubated for a period of 10 days.

Profile 2F – Membrane Filter Concentration

Profile 2F includes Profile 1 plus a membrane filtration procedure to concentrate potentially low number of contaminating bacteria and to remove anti-bacterial compounds such as antibiotics from the cell culture medium that might inhibit bacterial growth and lead to false negative results.

Profile 2C – Centrifugation Concentration 

Profile 2C includes Profile 1 and adds a centrifugation step (instead of filtration) for the concentration step. After centrifugation, the supernatant culture fluid, now devoid of cells and potentially contaminating bacteria, is removed and the pellet is re-suspended in sterile PBS and cultured in the same media used in Profile 2F. The advantages of this profile over Profile 2F is that it is a less complex procedure and is therefore less susceptible to potential contamination because manipulation of filter material is not required.

For optimum sample volumes for each profile and sterility sample preparation and shipping information, view Collection and Shipping SOP.


Identification of Microbial Contaminants

Performed by MALDI-TOF Mass Spectrometry.

DNA Sequencing (if contaminant is not identifiable by MALDI-TOF)

Laboratory Water Testing

Aerobic culture for one organism
Aerobic culture and colony count (bacteria only)
Aerobic culture and identification (bacteria only)
Aerobic culture, identification, and colony counts by species (bacteria only)
Aerobic culture, identification, and colony counts by species (thermotolerant coliforms only)
Aerobic culture, identification, and colony counts by species (total coliforms only)
Aerobic culture and colony count (bacteria and fungi)
Aerobic culture and identification (bacteria and fungi)
Aerobic culture, identification, and colony counts by species (bacteria and fungi)
Aerobic and Anaerobic culture, identification, and colony counts by species (bacteria and fungi)

Environmental Testing (Call for Pricing)

Sample Type Description
RODAC Plate Count Incubation and quantification of growth from client submitted plates.
RODAC Plate Count w/identification by MALDI-TOF MS

Incubation and quantification of growth from client submitted plates.

Includes identification by MALDI-TOF MS.

Environmental Swabs Swabs of environmental origin for the culture and
identification of pathogens or specific organisms.
Sanitized Surface Swabs

Paired (Pre/Post) swabs of sanitized surfaces for the efficacy
of sanitization procedures. Includes relative quantification.