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Sterilization is any process that removes, kills, or deactivates all forms of life (particularly microorganisms like fungi, bacteria, microbial spores, and unicellular eukaryotic organisms) and other biological agents like prions that are present in or on a specific surface, object, or fluid. Sterilization can be accomplished through a variety of methods, including heat, chemicals, irradiation, high pressure, and filtration. Disinfection, sanitization, and pasteurization are distinct from sterilization. Sterilization eliminates all forms of life and biological agents present, whereas other methods reduce the number of biological agents and other viable contaminants.
Pharmaceutical industries manufacture a wide range of medicines in the form of APIs and formulations. In the pharmaceutical industry, they use a variety of medical and diagnostic devices. A non-sterile product or facility makes the pharmaceutical product a potential carrier of microbial contaminants. Imagine a person gets a severe infection or a critical treatment fails due to microbial contamination in the medicines, tools, reagents, and chemicals used. The resources, money, effort, and time are all just wasted.
This example piques our interest and makes us wonder about sterility testing in the pharmaceutical industry.
Sterility Testing in the Pharmaceutical Industry
Sterility testing is a critical process in the pharmaceutical industry, as it ensures that their manufactured products are free of microorganisms. The sterility of a product is defined by the absence of viable and actively multiplying microorganisms when tested in specified culture media.
TM Media provides a wide range of culture media and other products that are specifically designed for various pharmaceutical testing.
In the pharmaceutical industry, this quality control test is performed on products that are required to be sterile, according to the guidelines.
Direct inoculation and membrane filtration are sterility testing methods used in the pharmaceutical industry as per the needs of the testing.
Sterility Testing Methods
Membrane Filtration Method (Open Funnel Method)
In this method, the sample is filtered through an open funnel with a filter.
Once the appropriate filter rinsing has been completed, the filter is removed, cut in half, and individually placed into each media type used for sterility testing: Soybean Casein Digest Medium (SCDM) and Fluid Thioglycollate Medium (FTM).
Membrane Filtration Method (Closed System Method)
This method requires a vacuum, which is created in canisters; the vacuum allows the microbiologist to withdraw samples directly from the sealed sample bottle using the attached needle. The sample is then split automatically between the two canisters and passed through both filters.
Following the appropriate filter rinse, each media type (SCDM and FTM) is added to the respective canister. The tubing is sealed, and each canister is incubated for the appropriate time and temperature.
Direct Inoculation Method
In the direct inoculation method, a sample is directly added to the culture media and then incubated to see if growth occurs. In this method, the sample volume should not exceed 10% of the volume of the culture medium.
According to the pharmacopoeia compendia, a 14-day incubation period is required for the sterility test to obtain a valid analytical result.
Why are Fluid Thioglycollate Medium and Soybean Casein Digest Medium preferred for sterility testing?
Fluid Thioglycollate Medium is a selective medium used to determine the oxygen requirements of microbes. It is used to detect microaerophilic and anaerobic microorganisms with the help of an oxygen gradient.
In the tube, oxygen is present at the top, and as we go downward, the concentration of oxygen gets reduced. Finally, at the bottom, there is no oxygen present at all.
The sodium thioglycollate in Fluid Thioglycollate Medium consumes oxygen, allowing obligate anaerobes to grow.
The resazurin dye indicates the presence of oxygen by turning pink. Thus, the resazurin dye indicates the oxygenated region in the tube.
The agar in this medium is added to prevent oxygen from reaching the bottom, the anoxic region.
Soybean Casein Digest Medium (SCDM) is used to detect aerobic bacteria and fungi. The papaic digest of soybean meal and the pancreatic digest of casein make this medium nutritious by providing amino acids and long-chain peptides for the growth of microorganisms. Natural sugars in soybeans promote the growth of fastidious organisms.
Solutions by TM Media for the Sterility Testing
Titan Biotech Ltd., a renowned name in the field of life sciences, started its journey in 1992 to innovate in the field of biotechnology and advanced life sciences. TM Media, the microbiology arm of Titan Biotech, is established for manufacturing a vast microbiology product portfolio ranging from Biological Media Bases, Dehydrated Culture Media, Media Supplements, Lab Consumables, Lab Equipment to all variants of Ready-to-Use Culture Media for the pharmaceutical industry and other key industries. Over the years, the demand for their product has increased manifolds, and they have successfully catered to all of it.
With its strong technical expertise and quality products, TM Media has expanded its wings in more than 77 countries.
TM Media provides a wide range of culture media and other products that are specifically designed for various pharmaceutical testing. All the products are manufactured in accordance with USP/EP/JP/IP. Dey-Engley’s Neutralizing Medium, Soyabean Casein Digest Agar, Soyabean Casein Digest Medium, and other Culture Media are available in Dehydrated as well as Ready-to-Use Plates of 90 mm and 55 mm sizes. The Soyabean Casein Digest Medium is also available in a 5-liter Ready-to-Use Bag which can be used in Media-fill activity. Specifically, for environmental monitoring,
TM Media had introduced a category ‘Absolute EM’, which includes the Microbial Air Monitoring System and Sterile Gamma-irradiated Ready-To-Use plates of 90 mm and 55 mm. For sterility testing, TM Media has created the Combo Sterility Kit. Each kit consists of 2 glass bottles (100 ml each) of Fluid Thioglycollate Medium and Soya Casein Digest Medium. Their Ready-to-Use Culture Media and Absolute EM range have made pharmaceutical research and quality assurance much simpler and safer with accurate results.
For more information: https://www.tmmedia.in/