Medical Device Bioburden Testing and Monitoring Services to ISO 11737-1

Despite best efforts to create a sterile manufacturing environment and end product, there will always be the hidden risk of introducing microorganisms. Contamination excursions can lead to a dangerous situation for your company and your patients. Bioburden testing is a key part of controlling your overall sterilization program and helps assess bioburden loads and address bacterial or fungal issues caused during production or by raw materials.  NAMSA can analyze the bioburden of your devices, assist in the determination of the root cause for excursions, and help you lower it to acceptable CFU levels.     

Quick facts about bioburden testing for medical devices: 

• Used to determine the microbial load on a medical device, component, material, or container

• Bioburden testing is an integral part of a sterilization program. Helps identify potential issues in production and controlled environment handling

• Multiple bioburden tests can be done: aerobic bacteria and fungi are the most common 

• ISO 11737-1 is the primary standard applicable to bioburden testing and monitoring 

NAMSA Has 3 Labs That Conduct Bioburden Analysis on Medical Devices and IVDs

Every year NAMSA laboratories in the US and Europe conduct more than 100,000 tests measuring biocompatibility, package integrity, microbiology and sterility. Bioburden testing is among the most important of those tests, measuring microbial contaminants that originate from the final cleaning, human handling, airborne particulate, of microbes bacteria found in and around the manufacturing environment. Regardless of the source, we will assess the bioburden load of your medical device taking into account: 

• Your manufacturing processes 

• Handling that occurs during manufacturing  

• Types of materials included in your device 

• Terminal packaging 

• Overall complexity of your device design 

How Bioburden Testing Works and the Services We Offer 

NAMSA conducts a wide range of bioburden tests. Each test is suited for measuring a specific category of microorganisms, and the method we use depends on your device and manufacturing process. To validate the bioburden test, we place a fixed number of microorganisms on your medical device and then we remove (extract) them using the same process used for the intended bioburden test. This tells us what percentage of the microrganisms were removed and determines how efficient that extraction process was. The more you are able to control a device’s bioburden, the stronger the validity is of that overall sterilization process. All NAMSA bioburden testing is conducted in full compliance with ISO 11737-1  We will help you determine how many product samples will be needed for bioburden testing. We offer a range of bioburden testing and related services including: 

• Product Bioburden Testing for Medical Devices, IVDs, Containers, or Components 

• Bioburden Monitoring to Maintain Manufacturing Process Control 

• Bioburden Trending and alert/action limit determination 

• Routine radiation dose audits compliant with ISO 11137-2 

• Sterilization Process Validation in Compliance with ISO 11137-2 and ISO 11135 

Meet our team of EU mdr Regulatory experts

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Deep Expertise in Medical Device Microbiology and Sterility

NAMSA conducts more than 100,000 medical device tests each year at seven lab facilities in the United States and Europe. Our team of biological safety testing experts and regulatory specialists have a deep understanding of the requirements needed to support new medical device submissions or maintain compliance. More than 95% of the tests we conduct for clients are delivered on time.  

Commonly Asked Questions about EU Technical Documentation

What is bioburden testing? 

Bioburden testing is a crucial process used to assess the number of viable microorganisms present in unsterilized materials or medical devices before they undergo sterilization. Testing helps ensure that the final product meets safety requirements and minimizes the risk of infection for patients. Microorganisms can originate from raw materials, the environment, cleaning processes, or human interaction with the device during manufacturing or packaging. By determining the bioburden, manufacturers can choose the appropriate sterilization method for their products, whether it’s gamma radiation, ethylene oxide, or another method. 

How often should bioburden testing be performed? 

The frequency of bioburden testing depends on several factors, including the type of medical device, its intended use, and regulatory requirements. Generally, manufacturers perform bioburden testing at critical points in the production process such as: 

• Initial assessment to determine the appropriate sterilization method 

• Routine monitoring to ensure ongoing compliance with standards and to detect deviations. With radiation sterilization methods it is conducted at a quarterly interval as part of routine validation maintenance, called dose audits.  

• Change control: When there are changes in materials, processes, or equipment 

Which microorganisms are typically tested during bioburden analysis? 

The most common microorganisms encountered in a typical medical device manufacturing and packaging environment that should be evaluated during bioburden analysis are: 

• Aerobic Bacterial species such as Staphylococcus and Bacillus. 

• Yeasts 

• Molds