Bioburden Estimation And Validation Or Recovery Efficiency Of Medical Devices

Welcome to Microbiology Testing Services of Shubhda Research Institute –Simulation Studies information page.

The information and outline given below is only for presenting the gist of the method to sponsors intending to test their product and is purely for educational purpose.


A sterile medical device is one that is free of viable microorganisms. International standards that specify requirements for validation and routine control of sterilization processes require, when it is necessary to supply a sterile medical device, that adventitious microbiological contamination of a medical device prior to sterilization be minimized.

 Bioburden is the sum of the microbial contributions from a number of sources including raw materials, manufacturing of components, assembly processes, manufacturing environment, assembly/manufacturing aids (e.g., compressed gases, water, lubricants), cleaning processes, and packaging of finished product.

The testing associated with these studies includes:

Bioburden Recovery Validation

Bioburden Estimation

Bacteriostasis/Fungistasis Testing

Sterility Testing

Biourden testing is conducted according to ISO 11737 and includes validation procedures.  Prior to conducting Bioburden Estimation, validation is performed. Validation procedures consist of assessment of the adequacy of the extraction techniques to remove microorganisms (Recovery Efficiency), the calculation of a correction factor based on the recovery efficiency and assessment of the adequacy of the culture conditions to optimize the count obtained.

Medical Devices such as TPU bag, catheters, prothesus, medical testing, surgical implant, lenses, dental implants etc. can be tested.

Turn over time: 10 to 15 days

If your firm wants to perform the “Simulation Study” simply Contact our Lab today
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