Bioburden / Microbial Assays |
Microbial assays involve a variety of tests, from the determination of the numbers and types of organisms naturally present on a product or material, to the assessment of a product or ingredient to have an antibacterial or preservative action against microorganisms. AppTec can perform the types of microbial assays listed below as well as customized studies. In this section - Bioburden Testing
Aerobic Bioburden
Fungal Bioburden
Spore Bioburden
Anaerobic Bioburden
Aerobic and Fungal Bioburden
Aerobic Bioburden Panel
Total Bioburden Panel
Bioburden Recovery Efficiency - Repetitive Recovery Method
Bioburden Recovery Efficiency - Spore Inoculation Method
- Microbial Identification Testing
Gram Stain
Colony Morphology
Gram Stain and Colony Morphology
Bacterial Identification
Fungi/Actinomyces Identification
- Microbial Limit Testing
USP Microbial Limit Test - Preparatory
USP Microbial Limit Test - Screening
USP Microbial Limit Test - Confirmatory
- Antimicrobial Assays
AATCC Method 30, Part III Antifungal Evaluation, Qualitative
AATCC Method 100 Antibacterial Evaluation, Quantitative
AATCC Method 147 Antibacterial Evaluation, Qualitative
AATCC Method 174, Part 1 Antibacterial, Qualitative (Carpets)
AATCC Method 174, Part 2 Antibacterial, Quantitative (Carpets)
AATCC Method 174, Part 3 Antifungal, Qualitative (Carpets)
ASTM G-21 Antifungal, Semi-Quantitative
ASTM G-22 Antibacterial, Qualitative
DOW 0923 (Shake Flask) Antibacterial, Quantitative
Kirby-Bauer Susceptibility Antibacterial, Quantitative
USP Preservative Effectiveness Test
USP Neutralization Validation
- Bacteriostasis/Fungistasis
Bacteriostasis / Fungistasis – Two Media (USP)
Bacteriostasis / Fungistasis – One Medium
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| Bioburden Testing Back to Top |
Bioburden testing is an assessment of the numbers and types of microorganisms present on a product, and may be used for assessment of incoming materials, as an indicator of manufacturing conditions, and to support sterilization validations. A determination of the recovery efficiency and characterization (grouping micro-organisms into categories) are both required for compliance with bioburden standards. All aspects of bioburden testing – test parameters, characterization and recovery efficiency – are performed according to specified ISO, AAMI, USP, or FDA standards.
| 1606000 | Aerobic microflora count. TURNAROUND TIME 10 days | | Aerobic Bioburden |
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| 1604000 | Mold and yeast count. Extracts are plated using media designed to grow only yeast and mold organisms (fungi). TURNAROUND TIME 10 days | | Fungal Bioburden |
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| 1605500 | Aerobic spore count. Extracts are heat shocked to eliminate everything but spores. TURNAROUND TIME 8 days | | Spore Bioburden |
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| 1605600 | Anaerobic microflora count. Extracts are incubated under anaerobic conditions. (Some facultative organisms may also grow.) TURNAROUND TIME 10 days | | Anaerobic Bioburden |
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| 1607000 | Separate aerobic and fungal microflora count. TURNAROUND TIME 10 days | | Aerobic and Fungal Bioburden |
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| 1603010 | Full aerobic characterization for products that have demonstrated no anaerobic bioburden. TURNAROUND TIME 10 days | Aerobic Bioburden Panel
Aerobic/Spore/Fungal |
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| 1605000 | Intended for items for which a full characterization of the bioburden is needed. TURNAROUND TIME 10 days | Total Bioburden Panel
Aerobic/Anaerobic/Spore/Fungal |
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| 1601000 | Devices are extracted multiple times to determine overall efficiency of the first extraction. The percent efficiency and the correction factor are calculated for use in future bioburden evaluations performed on the product. This method is not recommended for items which typically display a very low bioburden (e.g., less than 10 CFU per device). SUGGESTED SAMPLE
5-10 devices
Contact laboratory for sample details. TURNAROUND TIME 10 days | | Bioburden Recovery Efficiency-
Repetitive Recovery Method |
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| 1602000 | Previously sterilized devices are inoculated with a known quantity of bacterial spores and then subjected to the extraction process. The recovered spores are counted and a correction factor is calculated for use in future bioburden evaluations. SUGGESTED SAMPLE
3-10 sterile devices
Contact laboratory for sample details. TURNAROUND TIME 5 days | | Bioburden Recovery Efficiency-
Spore Inoculation Method |
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| Microbial Identification Testing Back to Top |
| 190601 | Differential staining technique used to categorize microorganisms. TURNAROUND TIME 2 days | | Gram Stain |
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| 190640 | Description of an organism's macroscopic appearance, including shape, color and texture. TURNAROUND TIME 2 days | | Colony Morphology |
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| 190630 | Description of an organism's macroscopic appearance, including shape, color and texture, plus differential staining to determine organism category. TURNAROUND TIME 2 days | Gram Stain and
Colony Morphology |
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| 190400 | Determination of the genus and species of a bacterial isolate. TURNAROUND TIME 3-14 days | | Bacterial Identification |
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| 190650 | Determination of the genus and species of a fungal isolate or genus and species identification of the Actinomyces. TURNAROUND TIME 10-14 days | | Fungi/Actinomyces Identification |
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| Microbial Limit Testing Back to Top |
Intended primarily for pharmaceutical articles, both finished and raw materials, the USP Microbial Limit test may also be useful for evaluating bioloads on select materials used in some medical devices. It is designed to provide an estimate of the number of viable aerobic microorganisms, both bacterial and fungal, and to screen for specific target microbial species.
Microbial limit tests are set up on Mondays, Tuesdays and Wednesdays.
Samples should arrive at least one day prior to testing. Samples will not be set up on holidays. |
| 161200 | This test should be performed on a regular basis – and as circumstances require subsequently – to demonstrate that the test specimen does not inhibit the multiplication, under test conditions, of microorganisms that may be present. Diluted samples of the material are inoculated with separate, diluted cultures of Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Salmonella species. TURNAROUND TIME 9 days |
Microbial Limit Preparatory Testing (USP) |
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| 161201 | This test is designed to determine total aerobic microbial count, total combined mold and yeast count and to demonstrate freedom from Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Salmonella species. TURNAROUND TIME 9 days |
USP Microbial Limit Test |
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| 161300 | Confirmatory testing is performed when additional tests (such as coagulase testing and oxidase testing) are required to either rule out or confirm the presence of Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Salmonella species. Additionally or alternatively, microbial identification can be performed. (See tests on Page A-4.) TURNAROUND TIME 2 - 4 days |
Microbial Limit Confirmatory Testing |
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| Antimicrobial Assays Back to Top |
Antimicrobial assays are used to determine or confirm the effectiveness of treatments applied to medical devices, medical and commercial textiles, and other products. Test methods for measuring the antimicrobial activity include ASTM, AATCC, and other modified methods. Testing includes antibacterial and antifungal activity, with both qualitative and quantitative assays available.
Minimum sample requirements 9 square inches or 6 inches long, per test
Untreated controls are recommended for all tests. |
| 110700 | Samples are inoculated with Aspergillus and evaluated for the degree of growth over a 7-day period. TURNAROUND TIME 10 days | AATCC Method 30, Part III
Antifungal Evaluation, Qualitative |
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| 110710 | Samples are inoculated with Staphylococcus and Klebsiella and evaluated for percent reduction of the bacteria over selected contact periods of 1 – 24 hours. TURNAROUND TIME 5 days | AATCC Method 100
Antibacterial Evaluation, Qualitative |
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| 110720 | Samples placed in direct contact with Staphylococcus and Klebsiella inoculum streaks are evaluated for inhibition of growth and zones of inhibition within 24 hours. TURNAROUND TIME 3 days | AATCC Method 147
Antibacterial Evaluation, Qualitative |
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| 110730 | The same principle as AATCC Method 147 (above), but specific for carpets. TURNAROUND TIME 3 days | AATCC Method 174, Part 1
Antibacterial Evaluation, Qualitative (Carpets) |
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| 110740 | The same principle as AATCC Method 100 (above), but specific for carpets. TURNAROUND TIME 5 days | AATCC Method 174, Part 2
Antibacterial Evaluation, Qualitative (Carpets) |
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| 110750 | The same principle as AATCC Method 30, Part III (previous page), but specific for carpets. TURNAROUND TIME 10 days | AATCC Method 174, Part 3
Antifungal Evaluation, Qualitative (Carpets) |
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| 110760 | Samples are inoculated with a mixture of five (5) fungi and evaluated for the degree of growth over a 21-day period. TURNAROUND TIME 28 days | ASTM G-21
Antifungal, Semi-Quantitative |
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| 110770 | Samples are placed in direct contact with agar that has been inoculated with Pseudomonas. The samples are then evaluated over a 21-day period for degree of growth or inhibition. TURNAROUND TIME 28 days | ASTM G-22
Antibacterial, Qualitative |
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| Samples are exposed to Klebsiella in a liquid suspension for one (1) hour under continuous agitation. The percent reduction of Klebsiella is then calculated. TURNAROUND TIME 5 days | DOW 0923 (Shake Flask)
Antibacterial, Qualitative |
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| 110790 | This is a modified susceptibility test where the sample is in direct contact with an inoculum of a specified organism. The sample is evaluated for zones of inhibition. TURNAROUND TIME 4 days | Kirby-Bauer Susceptibility
Antibacterial, Quantitative |
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| 190660 | Used to demonstrate the effectiveness of antimicrobial preservatives in sterile and non-sterile dosage forms. Samples are inoculated with known levels of microorganisms and are evaluated for degree of inhibition over a 28-day period. TURNAROUND TIME 40 days |
USP Antimicrobial Effectiveness |
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| 190661 | If a product possesses antimicrobial properties, it must be neutralized to recover viable microorganisms. This validation assay is used to demonstrate that the neutralization method employed is effective in inhibiting the antimicrobial properties of the product without impairing the recovery of viable microorganisms. TURNAROUND TIME 14 days |
USP Neutralization Validation |
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| Bacteriostasis/Fungistasis Back to Top |
| Bacteriostasis / fungistasis (B/F) testing is necessary to demonstrate that there are no substances produced by the test materials which would cause inhibition of bacterial or fungal growth in a sterility test (i.e., a false negative interpretation). Testing is performed by inoculating sterility test samples with low levels of selected organisms to ensure growth. B/F test parameters are based on USP, ISO, or AAMI requirements. |
| 190105 | Sample device or material is tested for growth inhibition using the current USP organisms for Soybean-Casein Digest Medium (SCDM) / Tryptic Soy Broth (TSB) and Fluid Thioglycollate Medium (FTM). (Additional organisms available upon request.) SAMPLE REQUIREMENTS
6 sterile product samples TURNAROUND TIME 10 days |
Bacteriostasis/Fungistasis
Two Media (USP) |
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| 190106 | Sample device or material is tested for growth inhibition using the current USP organisms for SCDM. This method is used when only Soybean-Casein Digest Medium (SCDM) / Tryptic Soy Broth (TSB) is used for sterility testing products. (Additional organisms available upon request.) SAMPLE REQUIREMENTS
3 sterile product samples TURNAROUND TIME 10 days | | Bacteriostasis/Fungistasis
One Medium |
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