Vinay Kumar Gupta
Qa Chemist and Validation Activities at Brawn Laboratories Limited
Based in Ghaziabad, India
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Seniority
Staff
Department
Science
Location
Ghaziabad
Industry
Hospitals and Health Care
Company size
1001 to 5000
Contact information
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v•••••••@brawnlabs.in
Phone
5 credits+91 ••• •••• ••••
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Background
About Vinay Kumar Gupta
Water system Change over and Third phase study of water system validation 2. Presently working in validation/Calibration team a. Dry Heat Sterilizer performance Re qualifications. b. Sterile & Non sterile Equipments Validation. c. Media fill validation. d. Process Validation. e. HVAC/Clean area Validation (HEPA filter integrity, Number of Air changes, air particle count, Air flow Pattern, Differential pressure monitoring, Temperature and RH monitoring and Viable air particle count-Air sampler method, Contact plate method, settle plate method and swab testing ), personnel monitoring f. Area qualification g. Autoclave performance Re qualifications. h. Optical inspection validation(Challenge test) i. Disinfectant validation. j. Hold time study of Sterile Garments k. Compressed air testing and its validation. In-Process Line clearances of Sterile & non Sterile area. a. Dispensing. b. Manufacturing. c. Dry Powder filling Injection. d. Liquid- Filling Injection. e. Granulation area. f. Compression. g. Coating and Packaging area. h. Verification of weighing balance, Magnehelic gauge, Temperature, and relative humidity of clean area/rooms. Ensuring that all Log sheets & Records are updated on – line with the operation. Closing and review of BMR and BPR. Monitoring of Temperature, Humidity, Cleaning, and Sanitation of all area. Checkout and assurance of In-Process activities in Manufacturing, Filling area, and Packaging area. Calibration of Pressure Gauge, Magnehelic Gauge, Volt meter, ammeter, Temperature controller and RPM counter
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