Bioburden test là gì
Producing safe products is a core goal of all medical device manufacturers and sterility assurance is a key component in achieving that goal. Many single use medical devices are terminally sterilized by ethylene oxide or radiation methods such as gamma or e-beam. The FDA and other regulatory bodies requires that the sterilization process be validated and these validations typically require a bioburden and sterility testing. Sterility testing and bioburden testing are also performed on devices as part of routine quality control. Show
Bioburden Testing of Medical DevicesA bioburden test determines how many microbes are on the medical device. Before performing the test, a suitability test must first be performed. The purpose of the bioburden suitability test (also called method validation) is to ensure that the bioburden test method is effective in recovering microorganisms that are present on the device and to show that the test method will allow the growth of the device microorganisms. To perform the method validation, a known low number of microorganisms are placed on a sterile device and then removed using the same method that would be used for the actual bioburden test. Based on the outcome of the method validation, a recovery factor is determined to account for the percentage of microorganisms that were not able to be removed from the device. After an acceptable method validation is complete, the device will undergo bioburden testing to determine their microbiological load. This device bioburden level is often used in sterilization validations to calculate the verification or sterilization dose a device may need. Additionally, as part of quality control, quarterly bioburden monitoring is done to determine whether the microbiological load on a device has changed. Sterility Testing of Medical DevicesWhen performing a sterility test, it is imperative that the lab is testing that the device is actually sterile rather than leaching out chemicals that could impair the growth, or even kill, microorganisms. Therefore, just like bioburden testing, sterility testing also has a suitability test. The sterility suitability test is called bacteriostasis and fungistasis testing. A bacteriostasis and fungistasis (B&F) test measures whether a device inhibits the growth of bacteria or fungi, which may lead to false negatives during sterility testing. The test is performed by adding the device to media and then inoculating the media with less than 100 CFU of three different organisms. If the three organisms are able to turn the media turbid, the device passes the B&F test and sterility testing can begin. Sterility testing of medical devices are typically performed using media called SCDM (Soybean-Casein Digest Medium). The device is physically placed in the media. The amount of sample required depends on the testing method chosen, but all methods require an incubation time of fourteen days. If the media has turned turbid after fourteen days, the sample has failed the sterility test. ISO 11137 Dose AuditsVerification dose and dose audits are performed according to ANSI/AAMI/ISO 11137. Dose audits are done as a check to ensure that the sterilization process is still producing adequately sterilized products. All sterility testing is conducted in an ISO Class 5 environment. The microbiology lab at Pacific BioLabs is experienced in preparing and testing a wide variety of devices, from small needles to large, complex devices. For large devices, Sample Item Portion (SIP) preparation may be necessary. This consists of cutting a device into pieces for testing, or selecting the most appropriate parts of a device for testing. Case Study: Challenges in Bioburden TestingPotential contaminants such as those from personnel, equipment, raw materials and even the air in a manufacturing facility can affect the quality of medical device and pharmaceutical products. Therefore, manufacturers require bioburden and sterility tests to assure these products are manufactured to utmost quality standards.
Bioburden and Sterility Testing ServicesRead More About Bioburden and Sterility Testing
Fast enumeration of Total Yeast & Mold Count (TYMC) & Total Aerobic Microbial Count (TAMC), in CFU (Colony Forming Units)
Bioburden refers to the total number of microorganisms present in a sample. Bioburden testing is essential for many industries such as the pharmaceutical, food & drinks and cosmetics industries. The contamination thresholds and the methods used vary according to each sector, but revealing the presence of all microorganisms sooner at the earliest possible stage is crucial for all these industries.
With MICA, get your bioburden test results in 3 minutes, after an unrivalled reduced time of incubation : < 24h for TAMC and < 48h for TYMC.
Incubation reduced to <24 hrs for TAMC & <48 hrs for TYMC compared to 3-5 days with the traditional method – Results in 3 minutes.
Same process and culture media as reference methods. Automated counting at an early stage of micro colony.
Adding only one Diamidex reagent before incubation for fast TAMC & TYMC detection.
A non-toxic and non-destructive process for microorganisms.
MICA BIOBURDEN TYMC: Total Yeast & Mold Count < 48hcompared to 5 days with usual reference methods
Microorganisms tested :
And many other to come!
MICA BIOBURDEN TAMC: Total Aerobic Microbial Count < 24hcompared to 3 days with usual reference methods
Microorganisms tested :
And many other to come!
Thanks to an unmatched optical resolution among colonies counters, MICA is capable of detecting and counting microorganisms at their micro colony stage.
MICA includes a software according to the targeted microorganism. The use of MICA is 21 CFR Part 11 compliant. The analysis history is accessible, and all data are exportable and can be integrated into a LIMS or CRM system making of MICA an essential decision support tool.
Designed as a turnkey solution, MICA is easy to use and to implement, by all technicians. The operator is guided step-by-step through a simplified protocol according to the targeted microorganism. The automatic counting of microcolonies ensures fewer uninterpretable results than traditional culture method, faster
MICA has been specifically created to meet laboratories’ and industrials’ needs to improve their productivity. Technician time savings are made thanks to a simplified protocol, including function such as repeatability of results & readings. Results are released faster to the client allowing a better microbiological workflow.
With MICA Fluorescence counter, choose your MICA Application Software and the possible consumables and quickly enumerate the following microorganisms:
Results in 24 hours 1 CFU / membrane Only culturable Alicyclobacillus spp. |