The term bioburden is used to describe the population Bioburden is the sum of the microbial contributions Furthermore the EN ISO does not. Bioburden Testing – ISO Biological Certified Lab. Gibraltar Laboratories Follows the Bioburden Testing Procedure Described in ISO A new version of the ISO document regarding bioburden testing was recently published. Its designation is ANSI/AAMI/ISO.

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Having this information, with the example and ideas on improving LODs, is a benefit to the industry. This is because inhibitory substances sometimes do not inactivate or kill the microorganisms; they merely inhibit them from replicating. Therefore, performing some bioburden testing of packaging to obtain data is a good practice. Typically, it is sufficient to perform a bioburden determination on a product after its removal from its packaging system and to omit bioburen packaging system from the determination.

Image courtesy of Nelson Laboratories.

Five Aspects of the ISO 11737-1:2018 Updates You Need to Know

This table indicates where collaborative efforts between the manufacturer and the testing lab would ensure the best testing method is utilized for the product in question.

The intent behind that test is identical to the bioburden method suitability test.

Additive Manufacturing in Medtech Deciphering Dosage: The importance of performing recovery efficiency testing has always been included, and is still represented in the version, but some details were added isoo some changes were made. This addition gives manufacturers more flexibility than what was allowed in the previous version.

It suggests that a repetitive recovery efficiency is appropriate for products with a moderate to high bioburden e. There is an analogous test used in qualifying a test of sterility.

Some might say that contaminated packaging can transfer microorganisms to product, which then can transfer to the patient. A Laser Focus on Precision.

Five Aspects Of The ISO Updates You Need To Know – Medical Product Outsourcing

Although it is not intended that these suggested values are exact cutoff points for either method, they ieo provide general guidance on when one might be more appropriate than the other. It is important to note it is not required that companies establish a desired recovery efficiency for each product type.

  ASTM D1434 PDF

Addressing Packaging and Sterilization Considerations. Although the spread plate is faster and easier, if zero colonies are detected on the plate, the results would be reported as less-than 50 CFU i.

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First is that packaging usually does not have direct contact with the patient, which makes the potential risk to the patient lower for the packaging than for product itself. Examples of where it is the responsibility of both the manufacturer and laboratory include selection of bioburden method, test method suitability for validation of the bioburden method, and removal technique.

Successfully navigating the maze of foreign medtech regulations requires diligence and proactive planning. Designing from Finish to Start. By using our website, you declare yourself in agreement with our use of cookies.

Bioburden testing is not meant to be an exact science, such as analytical chemistry, because the bioburden test involves two variables that are sometimes not quantifiable.

This is almost always best practice, but it does add cost to the testing. This means any transfer of microorganisms that could occur on product used on patients will also occur on product used for testing; thus, any microbiological contribution of packaging is accounted for.

When an inhibitory substance is present, the bioburden test results can look very low e. Based on this detailed understanding a manufacturer might know for a fact there are no inhibitory substances on, or in, their product and can provide a written rationale for not performing the test.

The intent of Section 8. Testing service and equipment providers are challenged to stay abreast of regulatory guidelines. Both tests are in place to ensure there is nothing in the test system that will inhibit viable microorganisms from replicating. The 50 percent value was arbitrarily selected and not based on data. Thus, it is not possible to expect bioburden test results to be as accurate or precise as one would with an analytical chemistry test.


It previously indicated that if the recovery efficiency percentage was less than 50 percent, improvements or alternate techniques should be considered.

What medical device manufacturers need to know about the recent changes to the ISO bioburden standard. In most cases, assistance and information from both sides is the best approach. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

Information on reviewing recovery efficiency data is provided in sections C. Attempting to have a low LOD is one of those reasonable measures to consider. The additions are specifically written so that a manufacturer might choose to omit performing the bioburden method nioburden test if they have a detailed understanding of all components and manufacturing processes relating to their product.

Some of the packaging will float on top of the extraction fluid, making a full extraction of the surface area difficult. LOD can be improved by the following: Annex C, section C. Bioburrden Examination of Converting, Gioburden, and Printing. What is intended to be sterile, When the package is an integral part of the product, or For specific evaluation. Manufacturers need to understand the potential contribution to product bioburden that packaging can make.

Bioburden Method Suitability Bioburden test methods are dependent on the ability of microorganisms to replicate in the bioburden test system. In the version of the standard, it was deemed important enough to add as one of the required items for selection of a test method.