We help manufacturers enumerate the population of viable microorganisms in medical devices for effective validation and control of sterilisation process.
For a sterilisation process to be effective on a newly manufactured pharmaceutical product or medical device, manufacturers must be aware of the number, properties and characteristics of microorganisms that occur in the products naturally or while going through the production process. This is a crucial step prior to setting sterilisation parameters such as dosing, temperature etc. to ensure that the process is effective and the product safe when used.
The purpose of bioburden testing is to enumerate the quantity of viable microorganisms on a pharmaceutical product, medical device, component, raw material, or package before sterilisation. Bioburden testing is also an important indicator of problems in the production process which could lead to product recalls later.
if you have any questions or would like to consult an expert in our laboratory.
Our Bioburden testing is conducted according to ISO 11737 and includes validation procedures.Before conducting Bioburden Testing,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.
Step 1 Prepare Sample
A sample of the test product is prepared depending on the physical characteristics of the product:
Water soluble products,non-fatty products that are not water soluble,fatty products,fluids or solids in aerosol form and transdermal patches each require different type of solvents.
Step 2 Isolate Microorganisms
Samples are typically tested through membrane filtration method or plate-count method.Other methods include most probable number(MPN).
At HTW,we rarely conduct tests using MPN method as it is least accurate.
Step 3 Culture Microorganisms
The incubation period,temperature and culture media can each affect the growth rate of microorganisms such as aerobic and anaerobic bacteria,yeast and mold.This in turn can affect the test result.
Step 4 Enumerate Microorganisms
HTW's enumeration methods include:
1.Total Aerobic Microbial Count (TAMC)
2.Total Yeasts and Molds Count (TYMC).
Step 5 Prepare Report
The findings are recorded and a report is prepared,detailing the outcome of the test.