MICRO BIOLOGICAL TESTING

Microbial limit tests

Sterility
Bacterial endotoxin tests using gel clot and kinetic techniques. Preservative efficacy testing and Antibiotic and vitamin assays.
Air borne particle count & Microbial validation of environment by settling plate method

Microbiological Method Validation

Microbiological Assay,

Bioburden

RWC Test, SC Test

Surgical Dressings and Medical Devices

Environmental count (Air Sampling 0f Agar Plates & Agar Strips)

Water analysis

Guidelines:

Biological Activity ( IIa and Xa of Chapter <851> USP) 
•   Bacterial Endotoxins (Chapter <85> USP) 
•   Sterility Testing (Chapter <71> USP) 
•   Method Validation as per ICH 
•   AMES Test as per OECD 471 
•   Preservative Efficacy Test (Chapter<51> USP)