IPRF has dedicated Staff, experience of more than 15 years and expertise in the field of microbiological studies. IPRF conducts microbiological tests like: Microbiological Method Validation, Microbiological Assay, Sterility, Preservative Efficacy, Microbial Limit, Bioburden, Bacterial Endotoxin, Environmental Monitoring and Water analysis. The transparency in the reporting is assured. We have separate facility controlled by personalized access to only authorized person. The Facility has separate and access control entry to only authorized person. We have the State of the art modern equipment facility. The equipments are operated through password protected software with consistent UPS supply.
Microbiological Method Validation
IPRF follows an essential rule of checking the suitability of a method for the given product. We conduct this assessment using specific parameters.
Microbiological Assay
Microbial assays are a technique to assess a compound’s potency or concentration. This is carried out by exposing microorganisms to the compound and determining its effect on them. Before testing the product, we make sure to follow the strict aseptic condition so as to get accuracy in assay analysis. We have dedicated LAF to check potency of drug / assay.
LAMINAR AIR FLOW MLT and ASSAY Testing Model No CAV1200
BIOSAFETY CABINET Model No CBS1200
LAMINAR AIR FLOW MLT and ASSAY Testing Model No CAV1200
HEATING BLOCK
Sterility
IPRF has separate sterility room with dedicated Biosafety cabinet controlled by restricted entry to test the product and Injection which are critically sensitive to test. The testing of such product is analysed by following strict aseptic condition so as to maintain the decency of product.
Microbial Limit Test
IPRF has separate Microbial limit test room with dedicated laminar air flow controlled by restricted entry to test the product. The testing of product is analysed by following aseptic condition so as to maintain the dignity of product. The testing has separate entry there by avoiding cross contamination of testing two different test individually.
Bacterial Endotoxin (LAL Test)
The LAL (limulus amoebocyte lysate) testing, also known as bacterial endotoxin test, is an in vitro assay used to detect the presence and concentration of bacterial endotoxins in drugs and biological products, and is an important part of pharmaceutical microbiology.
IPRF has facility with special equipment to test the endotoxin in the product. The test is carried out by experienced person.
