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Procurement Cultures & In-Process Bioburden

Procurement Cultures & In-Process Bioburden

In-process bioburden testing provides valuable information to the tissue bank.  If set up properly it provides both bioburden numbers and bioburden types, which data can be used for determining acceptability of the tissue to be processed.  Performance of a thorough tissue process validation usually results in an understanding of not just which types of microorganisms are permitted on tissue which will be processed, but also how many microorganisms are acceptable.

Applicable Standards

AAMI/ISO 11737    |    AATB Standards for Tissue Banking 13th Edition

Pricing/Quote

Test Price Request Quote
BIO310 - Bioburden - Aerobic, anaerobic bacteria and fungi
Per sample1 - 9
10+
$120.00
$115.00
Add
BIO310 - Bioburden - Aerobic, anaerobic bacteria and fungi
Per sample1 - 9
10+
$120.00
$115.00

Turn Around Time

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

Code Test TAT
BIO310 Bioburden - Aerobic, anaerobic bacteria and fungi 12
Code TAT
BIO310 12

Sample Specifications

BIO310: Minimum of 3 samples recommended

Study Outline

In-process bioburden testing provides valuable information to the tissue bank.  If set up properly it provides both bioburden numbers and bioburden types, which data can be used for determining acceptability of the tissue to be processed.  Performance of a thorough tissue process validation usually results in an understanding of not just which types of microorganisms are permitted on tissue which will be processed, but also how many microorganisms are acceptable.

The first step is a consultation with a tissue representative from Nelson Laboratories to ensure proper establishment of the test method.  This involves a discussion regarding incorporation of the test in the tissue bank’s current process, when the tissue should be pulled for testing, what types of tissue to test, and which test method will supply the desired type of data.  Most tissue banks have a good understanding of how to approach these items and Nelson Laboratories desires to share its experience in setting up this test.

The in-process bioburden method development step determines a test method which is properly neutralized and which can effectively extract the microorganisms from the tissue.  Both are critical aspects of the in-process bioburden test and must be performed prior to initiation of the routine testing.  This step will result in a validated test method which will be used for all future testing.  Note that if an extraction process is to be used the extraction step might be performed at the procurement site or at the tissue bank (if desired), followed by sending the extraction solution to Nelson for testing.  Alternatively the tissue might be sent to Nelson for extraction and testing, followed by discard of the tissue.

Two bioburden test methods are commonly used: extraction and MPN.  The extraction method is used when the extract solution can be filtered and when microorganisms are expected on most batches of tissue tested.  The MPN method (most probable number method) is used when the extract solution cannot be filtered (usually due to the presence of fats or oils in the solution) or when microorganisms are not expected on most batches of tissue tested.  Determination of which test is most appropriate for a particular situation is part of the initial consultation.

Tissue companies are always welcome to email or call our tissue representatives to discuss validation or testing.