Pharmaceutical

HiMedia has developed a range of products relating to Antibiotic Assay Media. Our world class products which use microbiological assay technique adhere to market standards and are experts’ recommendations for determining the potency of antibiotics. Our solutions have demonstrated excellent inhibitory effect on microorganisms, a deciding factor in accessing the potency of an antibiotic under suitable conditions.
Our products follow Antibiotic Assay Protocol (follow the cylinder plate method and the turbidimetric tube assay method). Media from HiMedia have been developed adhering to specifications of the USP, EP, BP and Indian Pharmacopoeia.

HiMedia has a complete range of Harmonized Media, for the Harmonized Microbial Limit Test (MLT) and sterility test methods practiced in European and world pharmaceutical industries. Our Harmonized MLT Media are certified products and standard laboratory practices compliant to USP/EP/BP/JP/IP whose harmonization requires new testing protocols and consequently newer dehydrated culture media compositions.
We have achieved compliance with the Global Standards of Harmonization. In order to test non-sterile drug products, implementation of newer testing protocols are required with this harmonization which also includes compositional changes for culture media which are utilized for testing these products for specified organisms.
As a continued effort, the Harmonized Sterility Test incorporates standards for regular sterility testing of media to harmonize various pharmacopoeias. Additionally, evaluation of nutritive, differential and selective properties of the media have been incorporated in the Harmonized Microbial Limit Tests.

HiMedia has a vast product range of Media for Microbial Limit Testing (MLT) methods for pharmaceutical Industries. The Microbial Limit Test is a primary and simple design to enumerate the number of microorganisms in terms of colony forming units (CFU) in a non-sterile product or raw material. The routine Microbial limit screening test comprises of total aerobic, yeast and mold counts along with the test for unrequired microorganisms. This procedure follows immersing the solution and then plate aliquots to calculate CFU/gram (or ml) of initial sample with option pour plate, spread plate or the filtration of material for the plating. The membrane filter is then placed on the surface of an agar plate. The most probable Number Method is deployed in cases where the product cannot be put into a solution. This method involves performing series of dilutions of the sample carried out in a specified number of tubes containing suitable medium and under specified incubation conditions. This will result in an estimate of the microbial population of the product using most probable number tables.
Our solutions also allow using other methods like Membrane Filtration, when there are few expected colony forming units in the sample to be tested. Membrane Filtration is an excellent method to test a large volume of liquid but has limitations as it can only count up to approximately 100 CFU/membrane.

Sterlity testing guidelines defined for testing of biologics of various pharmacopoeia in section 21 of the CFR (Code of Federal Regulations) and Food and Drug Administration are standard reference points regered by HiMedia Products as each biological product manufactured under GMP protocols requires sterility testing performed under GMP guidelines.
Our products establish a full range of sterility testing media and rinse solutions as per various pharmacopoeias. Direct Inoculation or Immersion and Membrane Filtration being the two most common types of sterility test methods used worldwide. The test article is inoculated directly into specified media as per the Direct Inoculation or Immersion method whereas in the Membrane Filtration method the test article has to initially pass through size exclusion membrane which has the capability to retain microorganisms. This filter is then rinsed before being transferred to the specified test medium. However, both of these testing methods test article or membrane is incubated for 14 days in the test media. The Immersion method is used for testing the majority of biological samples. Cases of large volumes are handled through the Membrane Filtration method.

HiMedia provides a vast catalog comprising of Vitamin Assay Media. Our products are recommended products for quantification of vitamins such as folic acid, niacin, pantothenic acid, vitamin B12 etc. from experts worldwide. Our product catalog of Inoculum preparation, Culture maintenance and Assay Medium provide complete solutions in three categories and have compositions conforming to pharmacopeia specifications. For preserving, maintaining and carrying the stock cultures, our Maintenance Media products provide all required nutrients. Our Inoculum Media has nutrients for the propagation of culture before usage. To quantify vitamin concentrations in unknown or against known standard concentration, we provide Assay Medias which use microbiological assay methods. The material under assay is determined by adding suitable concentration of the test substance to the basal medium and then comparing the growth response thus obtained with that of standard by utilizing recommended standard ATCC strains. Standard methods like turbidimetric method, cylinder plate method or cup plate method can be used to achieve this.