About HTW Laboratory:
We offer professional bioburden testing at a lower cost than other labs. Our customized testing solutions can enhance process efficiency and reduce testing cycles. For technical regulation support, technicians at HTW are able to help you understand technical regulations and product design specifications. Communicate with our experts to determine your needs and we will provide you with a free evaluation, proposal and quotation.
We help manufacturers enumerate the population of viable microorganisms in medical devices for effective validation and control of sterilisation process.
What is Bioburden Testing?
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.
Email us if you have any questions or would like to consult an expert in our laboratory.
The Bioburden Testing Procedure:
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.
The Bioburden Testing Process:
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.
Bioburden testing is a tedious process that must be undertaken by qualified microbiologists using verified methods. At HTW, bioburden testing is mostly conducted using membrane filtration method or plate-count method outlined in USP 61 and ISO 11737-1:2006.
Why Choose Us?
HTW Lab, accredited by CNAS, CMA, CNCA & A2LA, consistently operates competently and generates accurate and valid results in accordance with ISO/IEC 17025. Our lab meets the requirements of Good Laboratory Practice (GLP) and provides product testing service in accordance with national and global standards for both active and non-active medical devices. We are also IECEE CB Scheme Test Laboratory (CBTL). Thus, testing reports from HTW Lab can be accepted between countries.
Your Benefits at a Glance:
1.20 Years of experience
HTW has extensive experience in all types of devices and regulatory requirements across markets.
2.Provide free modification service
Together with our wealth of knowledge in complex regulations globally, HTW provides a complete suite of testing solutions according to your needs including free modification service.
3.Save time to global markets
With over 7,000 square meters of labs, HTW offers the best testing cycles and you don't have to wait in line, HTW offers 1-on-1 service.With our in-depth insight of global product quality and regulatory requirements, HTW can optimize your costs and minimize your time to market.
ISO/IEC 17025 lab, accreditated by CNAS, CMA,A2LA,GLP.
Testing costs are lower than other labs.
You can also contact us directly by email.