USP 71

USP 71, also known as sterility testing, is performed to confirm that sterile products are free of any viable microbial contaminants.

USP <71> test is used for product sterility testing for pharmaceutical, biopharmaceutical, and medical device industries. Products to be tested using USP 71 test includes, pharmaceutical formulations, medical devices, and radiopharmaceuticals.

USP Chapter 71 test takes 1-2 weeks to complete.

We test for USP 71 using the following microbial strains: Pseudomonas aeruginosa (ATCC 15442), Escherichia coli (ATCC 8739), Staphylococcus aureus (ATCC 6538P), Enterococcus hirae (ATCC 10541), Klebsiella pneumoniae (ATCC 4352), MRSA (ATCC 33591), Salmonella enterica ( ATCC 10708), Candida Albicans (MTCC 3017). Additional strains can be added on request.

Microbiological sterility testing can be defined as the testing of pharmaceutical products or medical devices and other materials for the absence of viable microbial contaminants. It is a very important quality control check to ensure the safety of the end product.

Sterility testing is a crucial procedure that helps determine whether or not the product of interest is fit for human use. This is important in order to minimize the presence of disease-causing organisms and enhance the quality and effectiveness of the products.

Membrane filtration method and direct inoculation are the two most common methods used in sterility testing. Membrane filtration involves passing the product through a membrane which is then inoculated in culture media to see if there is any growth of microorganisms. In the direct inoculation method, the product is directly added into the culture media and later incubated to evaluate the growth of microorganisms.

Sterility testing typically takes at least 14 days to complete.

Incubation for 14 days is necessary to ensure that slow-growing microorganisms, which may have been present in the product, are detected.

The direct inoculation method is one of the test methods used in sterility testing. In this method, the required volume of the product itself is directly placed in the culture medium. The inoculated media is next incubated and examined for the presence or absence of microbial growth. This method is normally applicable if products cannot be filtered.

Some of the common media that are used in sterility testing include Fluid Thioglycollate Medium for anaerobic bacteria and Soybean-Casein Digest Medium (Tryptic Soy Broth) for aerobic bacteria and fungi.

The sterility of the culture media is determined by incubating a portion of the culture media for 14 days at a specified temperature. The absence of bacterial growth indicates that the culture media is sterile.

Membrane filter method involves passing the product through a 0.45-micron membrane filter which captures the microorganisms. This filter is then incubated in a culture medium to detect the presence of microorganisms. This method is preferred for products that can be filtered such as aqueous solutions and some oily preparations.

Sterility testing is an important quality control measure that must be adopted by all pharmaceutical manufacturers in order to ensure the safety of drugs and medical devices. It helps in verifying the effectiveness of sterilization processes and eliminating viable microorganisms.

A 0.45-micron filter is used for sterility testing because it can effectively retain bacteria and fungi while allowing the flow of the liquid product. It is a standard pore size that filters out bacteria without compromising the integrity and quality of the product.

The main methods are membrane filtration and direct inoculation. The choice of method depends on the product’s nature and formulation.

The standard is designed to detect a wide range of microorganisms, including bacteria (both aerobic and anaerobic) and fungi.

Yes, sterility testing is applicable to medical devices that require sterility, such as implants and surgical instruments.

Yes, radiopharmaceuticals can be tested using this standard. However, additional precautions may be necessary due to their radioactive nature.

Bioburden testing measures the total number of viable microorganisms on a non-sterile product, while sterility testing confirms the absence of viable microorganisms in products intended to be sterile.

The sample size depends on the product type and batch size.