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Bioburden

Bioburden

The Bioburden test determines the total number of viable microorganisms in or on a medical device, container or component. It is performed on any product that requires control and/or monitoring of bioburden counts, usually as part of a sterilization program. This test acts as an early warning system for possible production problems that could lead to inadequate sterilization. It is also used to calculate the necessary dose for effective radiation sterilization and to monitor product routinely as part of quarterly dose audits.

Nelson Laboratories performs this test in accordance with ANSI/AAMI/ISO 11737-1 and is most commonly referenced in the Radiation Sterilization standards (ANSI/AAMI/ISO 11137-1 & 2) and the EO Sterilization standard (ANSIAAMI/ISO 11135).

Applicable Standards

  • ANSI/AAMI/ISO 11737
  • ANSI/AAMI/ISO 11137
  • ISO 11135
  • EN 1174

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT (days) Request Quote
BIO110 Bioburden - Aerobic bacteria only 12 Add
BIO120 Bioburden - Anaerobic bacteria only 12 Add
BIO130 Bioburden - Fungi only 12 Add
BIO140 Bioburden - Spores only 12 Add
BIO210 Bioburden - Aerobic and anaerobic bacteria 12 Add
BIO220 Bioburden - Aerobic bacteria and fungi 12 Add
BIO230 Bioburden - Aerobic bacteria and spores 12 Add
BIO310 Bioburden - Aerobic, anaerobic bacteria and fungi 12 Add
BIO320 Bioburden - Aerobic bacteria, spores and fungi 12 Add
BIO410 Bioburden - Aerobic, anaerobic bacteria, spores and fungi 12 Add
BIO710 Bioburden Pooling Fee, per pooled unit (plus cost of test) Add
BIO715 Bioburden Packaging Pooling Fee, per set w/ concurrent test (one result) Add
BIO720 Bioburden: Sample Item Portion (SIP) Preparation Fee, per set Add
BIO905 Bioburden - initial bioburden validation (3 samples) 13 Add
BIO910 Bioburden - Extraction efficiency, exhaustive rinse method, per unit 13 Add
BIO920 Bioburden - Extraction efficiency, inoculated product method, per unit 13 Add
BTS110 Bioburden for Tissue: Single organism (Aerob., Anaerobe, Spore or Fungi) 12 Add
BTS115 Bioburden for Tissue: 7H11 Agar Testing - Dilution 21 Add
BTS116 Bioburden for Tissue: 7H11 Agar Testing 21 Add
BTS220 Bioburden for Tissue: Aerobic bacteria & fungi 12 Add
BTS310 Bioburden for Tissue: Aerobic & anaerobic bacteria, and fungi 12 Add
BTS410 Bioburden for Tissue: Aerobic & anaerobic bacteria, spores and fungi 12 Add
BTS815 Tissue: Standard MPN Method 21 Add
BIO110 - Bioburden - Aerobic bacteria only
12 days
BIO120 - Bioburden - Anaerobic bacteria only
12 days
BIO130 - Bioburden - Fungi only
12 days
BIO140 - Bioburden - Spores only
12 days
BIO210 - Bioburden - Aerobic and anaerobic bacteria
12 days
BIO220 - Bioburden - Aerobic bacteria and fungi
12 days
BIO230 - Bioburden - Aerobic bacteria and spores
12 days
BIO310 - Bioburden - Aerobic, anaerobic bacteria and fungi
12 days
BIO320 - Bioburden - Aerobic bacteria, spores and fungi
12 days
BIO410 - Bioburden - Aerobic, anaerobic bacteria, spores and fungi
12 days
BIO710 - Bioburden Pooling Fee, per pooled unit (plus cost of test)
Standard TAT not available for this product
BIO715 - Bioburden Packaging Pooling Fee, per set w/ concurrent test (one result)
Standard TAT not available for this product
BIO720 - Bioburden: Sample Item Portion (SIP) Preparation Fee, per set
Standard TAT not available for this product
BIO905 - Bioburden - initial bioburden validation (3 samples)
13 days
BIO910 - Bioburden - Extraction efficiency, exhaustive rinse method, per unit
13 days
BIO920 - Bioburden - Extraction efficiency, inoculated product method, per unit
13 days
BTS110 - Bioburden for Tissue: Single organism (Aerob., Anaerobe, Spore or Fungi)
12 days
BTS115 - Bioburden for Tissue: 7H11 Agar Testing - Dilution
21 days
BTS116 - Bioburden for Tissue: 7H11 Agar Testing
21 days
BTS220 - Bioburden for Tissue: Aerobic bacteria & fungi
12 days
BTS310 - Bioburden for Tissue: Aerobic & anaerobic bacteria, and fungi
12 days
BTS410 - Bioburden for Tissue: Aerobic & anaerobic bacteria, spores and fungi
12 days
BTS815 - Tissue: Standard MPN Method
21 days

Sample Specifications

BIO110: Minimum of 3 samples recommended
BIO120: Minimum of 3 samples recommended
BIO130: Minimum of 3 samples recommended
BIO140: Minimum of 3 samples recommended
BIO210: Minimum of 3 samples recommended
BIO220: Minimum of 3 samples recommended
BIO230: Minimum of 3 samples recommended
BIO310: Minimum of 3 samples recommended
BIO320: Minimum of 3 samples recommended
BIO410: Minimum of 3 samples recommended
BIO905: Minimum of 3 samples recommended
BIO910: Minimum of 3 samples recommended
BIO920: Minimum of 3 samples recommended
BTS110: Minimum of 3 recommended
BTS115: Minimum of 3 recommended
BTS116: Minimum of 3 recommended
BTS220: Minimum of 3 recommended
BTS310: Minimum of 3 recommended
BTS410: Minimum of 3 recommended

Study Outline

Routine testing of medical devices should be performed to demonstrate that the manufacturing process remains in control. The appropriate frequency and number of samples depend upon the sterility assurance level (SAL), type of product, type of sterilization used, environmental control and the process controls of the manufacturer.

In order to validate a bioburden test, a recovery efficiency needs to be performed.  There are essentially two approaches available, repetitive treatment (also referred to as exhaustive recovery) or product inoculation.  Ideally, a recovery efficiency should be established prior to the start of any bioburden test.  It should be performed on a minimum of three samples.  The recovery efficiency is then validated and can be applied to all future testing of that product.
 
The AAMI Radiation Sterilization guideline (ANSI/AAMI/ISO 11137) mandates testing 10 samples for bioburden with each quarterly dose audit. Monthly bioburden testing may be required depending on the validated sterilization dose. 
 
For products validated using the Industrial Ethylene Oxide Sterilization Guideline (AAMI/ANSI/ISO 11135), the type and frequency of bioburden tests performed will also vary with the method used in the initial validation. Most products are validated using the overkill method, where performing bioburden testing of 3 – 10 samples quarterly is sufficient. Products validated using the absolute bioburden method require frequent and significant bioburden testing. Even products validated with the BI/bioburden method should be tested periodically (at least quarterly) for bioburden.
 
Bioburden tests may include aerobic bacteria, spores, aerobic fungi (yeasts and molds) and anaerobes. Many factors enter into the choice of the type of tests most appropriate for your product. Generally, one should test for aerobic bacteria and fungi.

For products that cannot be tested using the extraction method such as liquids, powders or products with low bioburden the Most Probable Number (MPN) test may be utilized.  This testing involves immersing the product directly in nutritive media and following a seven day incubation, scoring the media for growth or no growth. 

We’re happy to help you create a Bioburden testing schedule and identify the right tests for your product.

The method of obtaining samples for bioburden influence the test results. The preferred method for evaluating products or processes is to obtain random samples. These samples may be selected from routine production, which should include products produced at different times during the production of a single lot. The selected production lot  needs to be representative of typical processing, conditions and should include all steps of manufacturing except sterilization. Samples may be obtained from in-process rejected materials if those materials have been subjected to the same processing conditions used for the remainder of the lot. Please be as clean as possible when sampling.