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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Research, Develop, Produce, Repeat. The importance of performing recovery efficiency testing has always been included, and is still represented in the version, but some details were added and some changes were made. 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 Value of Outside Evaluation: Some might say that swabbing could be used to remedy that issue.

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

Typically, it is sufficient to perform a bioburden determination on a product after its removal from its packaging system and to omit the packaging system from the determination.

Multiple factors are impacting the closing, but critical, processes associated with the end of product manufacturing. Table of Responsibilities Although compliance with device standards is ultimately the responsibility of the manufacturer, there has been confusion in the industry regarding where some responsibilities lay. At that point, proper implementation of change control and good microbiological controls in inspection and storage processes is sufficient.

Bioburden Testing ISO | Medical Device Testing | Nova Biologicals

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. Subscribe Free Magazine eNewsletter.

A Laser Focus on Precision. 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. However issues associated with swabbing such as poor recovery efficiency from the surface to the swab and then poor recovery from the swab to the test system indicate this might not be the best method.


Inclusion of packaging usually entails additional cutting and manipulation to ensure that it will fit into the container used for testing. Designing from Finish to Start. Additive Manufacturing in Medtech Deciphering Dosage: Addressing Peak Issues in Medtech.

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

That being said, however, it is important to take reasonable measures to make bioburden results as valid as possible. Some in the industry believed that routine testing of all interior packaging was required e.

Neither variable is consistent in different circumstances, and they are not easily explainable with the laws of physics. Sometimes, however, an unknown inhibitory substance can be present that can be problematic because the manufacturer may believe there is no need to test for inhibitory substances.

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 of Section 8. Therefore, performing some bioburden testing of packaging to obtain data is a good practice. For example, there might be residuals from cleaning or disinfecting processes on the product, or on components of the product that are provided by a supplier.

Bioburden Method Suitability Bioburden test methods are dependent on the ability of microorganisms to replicate in the bioburden test system. Medical device research and development strategy urges moderation and market analysis. What medical device manufacturers need to know about the recent changes to the ISO bioburden standard.

Some might say that contaminated packaging can transfer microorganisms to product, which then can transfer to the patient. The effectiveness 11737 the bioburden extraction process is determined in a recovery efficiency test.

Since guidance on this topic was excluded from the standard, some manufacturers performed routine bioburden testing for all inner packaging. Determination of a population of microorganisms on products. 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.

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


Manufacturers are usually recommended to test packaging initially, but in a separate container to determine the separate packaging bioburden counts from product bioburden counts. LOD can be improved by the following: This same requirement was added to 7.

Though the document has a number of changes, this article will highlight the top five things manufacturers need to biobuurden. The second variable is that the test is meant to detect living organisms, and organisms vary in how they replicate, remain static, or die due to subtle differences in their environment.

The additions are specifically written so that a manufacturer might choose to omit performing the bioburden method suitability test if they have a detailed understanding of all bioburdeh and manufacturing processes relating to their product.

One answer is to test packaging separately from the product. The intent behind that test is identical to the bioburden method suitability test. When there is added cost but little or no true benefit, continued use of the practice should be questioned. A new version of the ISO document regarding bioburden testing was recently published. This is almost always best practice, but it does add cost to the testing.

Image courtesy of Nelson Laboratories. The inhibitory substance is biooburden known to the manufacturer because it is intentionally included as part of the product i. The 50 percent value was arbitrarily selected and not based on data. Therefore, the LOD for this example is 4. In an attempt to provide clearer guidance for both manufacturers and testing laboratories, a table of responsibilities has been included in Annex D. Also, when packaging is tested with product, it usually fills the container which further increases the difficulty of extraction.

However, if bioburden recovery efficiency results fall below a target or desired value, another technique should be attempted e.