Detecting the absence or presence of viable microorganisms in pharmaceutical and medical products is very crucial. It is when you need sterility testing.
Sterility testing helps ensure the safety and efficacy of medical products or systems. Whether it is injectable drugs, ophthalmic preparations, or implantable devices, you should perform this test to assess the existence of microbial colonies.
At PLS Analytical, we use proper tools and techniques to confirm the presence of extraneous viable contaminating microorganisms in biological parenteral. If you want to guarantee that your sterile products do not contain viable bacteria, you can try out our sterility testing methods.
Need to know more? Get in touch with us for more details.
Opt for Our Advanced Methods for Sterility Testing in Microbiology
Being one of the leading microbiology testing labs, we ensure meeting the standards set in USP <71>, EU Pharmacopoeia < 2.6.1>, and JP Pharmacopoeia <4.06> while delivering our microbiological sterility testing services. In the case of pharmaceutical products, we provide -
Membrane Filtration: Membrane filtration is considered the best regulatory method of sterility testing. The method involves passing the sample through a 0.45 µm sterile filter that retains microorganisms. The filter when transferred onto a growth medium, such as agar, allows any viable microorganisms present in the sample to grow and form colonies. Later on, we can count the number of colonies and rinse away the components in the sample that may cause turbidity or inhibit growth.
Direct Inoculation: This method involves inoculating a sample into suitable culture media before incubation. The media we use can be broth or solid agar, depending on the nature of the product being tested. Ideally, only small volumes of the sample are used in the culture medium. On one hand, if the sample appears cloudy after inoculation, it becomes difficult to determine turbidity. On the other hand, if the product has antimicrobial properties, the sample needs to be neutralized to ensure microbial growth is not inhibited.
Direct Transfer: This process involves assessing the device in direct contact with the test media during incubation. It is the period when microorganisms grow and multiply, helping experts to determine the presence of viable contaminating microorganisms and clean them
Product Flush: This method works well when you need to ensure the microbiological safety and quality of products with hollow tubes. It involves flushing out the tube with a rinsing fluid and filtering the eluate using a submicron membrane. Later on, we place the sample on a suitable media for incubation.
Accurate Sterility Testing at PLS Analytical
At PLS Analytical, we perform sterility testing under strict aseptic conditions to prevent contamination during the process. Our team of professionals follows appropriate practices and guidelines, ensuring the integrity of the test. So, do you need to perform sterility testing for your medical products and devices? PLS Analytical is just a call away.