Bioburden Testing
Situated in Mumbai, Biotech Testing Services specializes in Bioburden Testing. Essentially, bioburden testing is a vital process that quantifies viable microorganisms on pharmaceutical products, medical devices, raw materials, and packaging materials. This testing method pinpoints bioburden originating from raw materials, personnel, or the manufacturing environment. Consequently, it serves as a key indicator of hygienic conditions during production. The importance of bioburden testing lies in its role in preventing potential product recalls and setting sterilization parameters such as dosing and temperature.
There are several methods to conduct Bioburden Testing, including ISO 11737, USP 61, USP 62, and the Euro Pharma method. This comprehensive approach detects all types of viable microorganisms, including bacteria, yeasts, and molds on both sterile and non-sterile products before sterilization.
Moreover, Air Bioburden, which represents the quantity of viable microorganisms in every cubic foot of air, is a critical factor. It plays a significant role in preventing infection transmission through airborne dust, respiratory droplets, or droplet nuclei. Studies suggest that 10–33% of hospital-acquired infections (HAIs) are directly linked to air transmission. Therefore, maintaining low air bioburden is crucial in hospital clean rooms and clean room manufacturing units to ensure safety and regulatory compliance. Regular assessments of air bioburden are performed according to the USP 1116 standard to evaluate the effectiveness of cleaning measures.
Methods of Testing
ISO 11737 - ISO Standard Test
For Medical devices & Health care products
Determination of population of Microorganism on Product
Primarily, this method is designed to determine the population of microorganisms on or in a medical device. It serves as an integral part of the validation and routine control of a sterilization process. Additionally, it can be employed for the enumeration of viable microorganisms in healthcare products, components, raw materials, or packages. Interestingly, this method offers a selection of Bioburden recovery approaches such as Ultrasonic, Stomaching, Vortexing, etc.
When it comes to results, they are expressed as the Number of Viable bacteria / fungus in CFU/ gram.
Importantly, please note that the turnaround time for this process is approximately 7 days.
USP Standard Tests
For Microbiological examination of non-sterile products
Total bacterial count
Total fungal count
Primarily, the USP 61 test is a fundamental method in bioburden testing. It plays a crucial role in examining non-sterile products by quantifying bacteria and fungi. This ensures that products comply with microbiological quality specifications. Furthermore, the test employs neutralization and dilution techniques, utilizing enumeration methods such as Membrane Filtration or Plate-Count Methods. Consequently, it’s an indispensable tool for industries like pharmaceuticals, cosmetics, and personal care products to uphold product safety and quality. Additionally, it aids in maintaining stringent industry standards.
Microbiological Examination of Non-sterile Products: Tests for Specified Microorganisms
Primarily, the USP 62 test forms a integral component of bioburden testing. Specifically designed to detect specified microorganisms in non-sterile products, it plays a pivotal role in ensuring product safety and quality.
Notably, it identifies potential pathogens such as Escherichia coli, Salmonella, Pseudomonas aeruginosa, Staphylococcus aureus, Clostridium Sporogenes, Bile Tolerant Gram - Negative Bacteria and Candida albicans. Furthermore, it’s an essential tool for various industries, including pharmaceuticals, cosmetics, and personal care products. Consequently, it aids in upholding stringent industry standards. Additionally, by detecting potential pathogens, it contributes significantly to public health and safety.
Euro Pharma Standard Tests
For Microbiological examination of non-sterile products
Microbiological examination of non-sterile products (Total Viable Aerobic Count)
Total bacterial count
Total fungal count
At BTS, we specialize in bioburden testing following the Euro Pharmacopoeia standard. This forms a crucial part of our microbiological examination of non-sterile products. Primarily, our comprehensive testing includes determining the Total Viable Aerobic Count (TVAC), a key aspect of ensuring product safety and quality.
Our bioburden testing process involves quantifying the total bacterial count and total fungal count present in a product. Notably, this is essential in identifying any potential microbial contamination that could compromise the product’s integrity.
By adhering to the Euro Pharma standard, we ensure a high level of quality control in our testing processes. Consequently, we provide reliable and accurate results for our clients. Trust BTS for your bioburden testing needs.
Microbiological Examination of Non-sterile Products: Tests for Specified Microorganisms
At BTS, we conduct a bioburden testing process that adheres to the Euro Pharma standard for the Microbiological Examination of Non-sterile Products. Specifically, our tests are designed to detect specified microorganisms.
Primarily, Euro Pharma standard testing process identifies Bile Tolerant Gram - Negative Bacteria. Additionally, we test for the presence of specific bacteria such as Escherichia coli, Salmonella, and Pseudomonas aeruginosa.
Furthermore, we also detect other microorganisms like Staphylococcus aureus, Clostridium Sporogenes, and Candida albicans.
Consequently, our comprehensive bioburden testing ensures the safety and quality of non-sterile products by identifying potential microbial contaminants. Trust BTS for your bioburden testing needs