Test if the antimicrobial agent in the formulation is effective. Required for <795> <797> multi-dose formulations

Test if the antimicrobial agent in the formulation is effective. Required for <795> <797> multi-dose formulations

Test if the antimicrobial agent in the formulation is effective. Required for <795> <797> multi-dose formulations.

Test if the antimicrobial agent in the formulation is effective. Required for <795> <797> multi-dose formulations

Bacterial spores in a growth medium or inoculated to a spore or paper strip, which are sterilized for the drug or medical device, recovered and then counted for survivors

Bacterial spores in a growth medium or inoculated to a spore or paper strip, which are sterilized for the drug or medical device, recovered and then counted for survivors

Bacterial spores in a growth medium or inoculated to a spore or paper strip, which are sterilized for the drug or medical device, recovered and then counted for survivors

Bacterial spores in a growth medium or inoculated to a spore or paper strip, which are sterilized for the drug or medical device, recovered and then counted for survivors

Checks the levels of bacterial endotoxin in finished product. Required for <797> batch release. Validation of the Endotoxin test method.

Checks the levels of bacterial endotoxin in finished product. Required for <797> batch release. Validation of the Endotoxin test method.

Bacterial endotoxin tests (BETs) follow the Limulus Amoebocyte Lysate (LAL) testing procedures guided by USP 85

ncubation and enumeration by <797>. Microbial Identification required if limits are exceeded.

Processed day of receipt. Microbial Identification required if limits are exceeded.

Check for fungal contamination.

Check for fungal contamination.

Check for fungal contamination.

Incubation and enumeration by <797>, which requires one hand per competency evaluation.

Check the possible presence of Burkholderia Cepacia Complex in product.

Check the possible presence of Burkholderia Cepacia Complex in product.

Check the level at which a particular antimicrobial drug inhibits the growth of Burkholderia Cepacia

Check the level at which a particular antimicrobial drug inhibits the growth of Burkholderia Cepacia

Determine the presence or absence of a specified list of microorganisms within nutritional and dietary supplements: Clostridium species, Escherichia coli, Salmonella species, and/or Staphylococcus aureus

Determine the presence or absence of a specified list of microorganisms within nutritional and dietary supplements: Clostridium species, Escherichia coli, Salmonella species, and/or Staphylococcus aureus

Quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions.

Quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions.

Quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions

Check the level at which a particular antimicrobial inhibits the growth of a specific microbial strain.

Check the level at which a particular antimicrobial inhibits the growth of a specific microbial strain.

Quantitative test (plate count) to enumerate bacteria and fungi that may be present in non-sterile Nutritional and Dietary supplements. The tests performed are . Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC).

Quantitative test (plate count) to enumerate bacteria and fungi that may be present in non-sterile Nutritional and Dietary supplements. The tests performed are . Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC).

This Test consists of an initial enrichment of the sample in an appropriate neutralizer broth, and then streaking the enriched sample onto selective media for determination of the presence or absence of the specified objectionable microorganisms. Tests for Specified Microorganisms (Antimicrobial Active) measures the level at which a particular antimicrobial inhibits the growth of a specific microbial strain.

This test or an equivalent test is performed at least annually under conditions that closely simulate the most challenging or stressful conditions encountered during compounding according to <797>

The Gram stain is used to determine bacteria as Gram positive or Gram negative based on the chemical and physical properties

Th test (GPT) is performed by inoculating new batches of media with a small number of microorganisms and compare with prior tested or approved media batches

Check specifically for presence of Mycoplasma contamination

Test for microbial contamination of sterile products. Must be compliant with <71> batch sizes. Required for <797> batch release

Verify the suitability of the sterility testing method. Required for <797> compliance.

Verify the suitability of the sterility testing method. Required for <797> compliance.

Rapid test for microbial contamination of sterile products. Must be compliant with <71> batch sizes. Required for <797> batch release.

Rapid test for microbial contamination of sterile products. Must be compliant with <71> batch sizes. Required for <797> batch release.

Rapid test for microbial contamination of sterile products. Must be compliant with <71> batch sizes. Required for <797> batch release.

Rapid test for microbial contamination of sterile products. Must be compliant with <71> batch sizes. Required for <797> batch release.

Rapid test for microbial contamination of sterile products. Must be compliant with <71> batch sizes. Required for <797> batch release.