TESTING SERVICES

 
 
EN ISO 11737 PART-I
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
 
 
 
Probiotic Formulations Bioassay
  • Bioassays
  • pH Simulation studies
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Shubhda Research Institute offers hands-on practical training programs at different levels addressing specific industries so as to hone your skills and techniques.
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Ready-To-Use Media Plates
Rapid testing and quick reliable results are of utmost importance today. To serve this purpose, Shubhda Research Institute offers “Ready-To-Use” pre-poured petri plates.
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Sample Based Tests
   
Antimicrobial Hard Surfaces For Bacteria
Antimicrobial Hard Surfaces For Fungi
Antimicrobial Textiles For Bacteria
Antimicrobial Textiles For Fungi
Disinfectants And Sanitizers Testing
Paint Films Testing
Probiotic Formulations Bioassay
Food, Water & Dairy Product Testing
   
Industries that we serve
   
Plastic and Glass
Textiles, Mattresses & Carpets
Pharmaceutical & Biotechnology 
Medical Devices and Surgical
Probiotic and Prebiotics
Water and Beverages
Food and Nutraceuticals
Dairy and Milk Products
Cosmetics and Personal Care
Paper and Paint
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Shubhda Research Institute

Unit No. 104, Building No. 14, HDIL Industrial Park, Chandansar, Off Western Express Highway, VIRAR (East), District: Thane, Maharashtra, INDIA 401305.

   
Tel : +91-8087737733 / +91-250-3298345
Mobile : +91-8007237812 / +91-9326841474
Email : info@sribioservices.com /
sribioservices@gmail.com

 
 
 
   
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