expertise in the field of Quality Control / Quality Assurance / Bacterial endotoxin Testing/Microbiological analysis / chemical analysis / Microbiological Validations, aseptic processing / Laboratory set-Up, in the area of Pharmaceutical/Hospitals / Agro/Food processing / Waste Management / Biotechnology Hygiene Management / Microbiological Monitoring of environment / Packaged Drinking Water Industries.
We provide high quality and timely services by considering the recent trends , advance technical concepts along with scientific background and to be applied in routine work environment field with an idea of providing complete solutions to our valued customers.
We Are Specialized In
Microbiological Methods : USP, BP, IP, JP methods with developmental activities and regulatory documentation.
Bacterial endotoxin test methods with developmental activities and regulatory documentation. Training and Testing-Gel Clot, KTA, KCA.
Microbiological Consulting and auditing.
Laboratory setup and implementation.
SOP and GXP documentation.
Audit compliance write-up and implementation on site
Microbiological Method development and Qualifications.
Microbiological Monitoring of environment, Utility, risk assessment.
Training topic on endotoxin covers,
Endotoxins — Introduction, source, importance.
Sample handling and preparation reagents for, analysis .
Interference, trouble shooting as well control points from RM testing to finish product.
An overview of the LAL/Endotoxin reaction/Requirements for analysis
Calculation of MVD and sample dilution scheme.
Explaining the flow of the test that includes, Standard and test sample preparation.
Detailed demonstration of the test methods including a discussion and case study.
Practical approachesconsidered for analysis.
Results & interpretation
Reporting Format and SOP
Complete validation demonstration and resolution of technical difficulties. />