HEAD
JULPHAR
Total des années d'expérience :22 years, 4 Mois
using, qualifying and troubleshooting the following instruments: HPLC, GC, FT-IR,
UV, KF Titrator, Dissolution, Disintegration tester, Friability, Hardness tester and practiced wet
chemistry.
Sterility testing, Endotoxin, Particulate Matter, Microbial limit test, Bioburden, Sterilization,
Antibiotic Sensitivity test, IQ, OQ, PQ, Air Borne Particle count, Water System validation and
Beta lactam contamination studies., etc.
cGMP, GLP, Total
Sterility test my manifold (Mf method) and by Canister method (Steritest).
Sterility test method Validation, Validation of diluents used for sterility test, Negative control test,
product positive control test.
Endotoxin analysis of sterile finished products, intermediates, Raw material and water for
injection (WFI) and purified water.
Gel clot method
Kinetic turbidometric method (Biolise) using Power wave 340 Spectrophotometer.
Particulate matter analysis of sterile finished products, Semi finished products as per USP.
Visual test (50µ -100µ )
Obscuration test using micro slide gridded membrane technique (10µ - 50µ )
Liquid borne Particulate count (HIAC-ROYCO) (10µ, 15µ, 20µ, 25µ, 30µ, 35µ, 40µ
AIMTA, NEWDELHI-66% Diploma in HACCP-Hazard Analysis and Critical Control Points-2007.