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EDUCATION: University of Puerto Rico (Mayagüez Campus -CAAM) BS, Biology (75 credits in Biology, 27 in Microbiology); MS, Microbiology - Phytopathology (56 credits, 32 in Microbiology)
BACKGROUND SUMMARY: Managerial, supervisory, qualification-validation, auditing, equipment design/selection and process development experience at corporate level, QC and Manufacturing. Work has been done for biotechnology (mammalian cells culture; bulk/ finished product), sterile products (LVP, SVP, suspensions, solutions, ophthalmic, otics, ointments, lyo, pre-filled syringes, bags, etc.), bulk pharmaceutical chemicals, fermentation (bio-transformation & fermentation) and non-sterile pharmaceuticals (solids, liquids & semi-solids). Experience on equipment/ facility qualification processes (URS to IOQ-PQ), facilities layout evaluations & cleaning validation. Knowledge of isolation/ containment technology - VHP cycles development; autoclaves cycles development (saturated steam, air-steam mixture & superheated water). Good understanding of utilities and facilities. Experience on gowning/ aseptic technique (many trainings developed).
Expert in pharmaceutical microbiology has broad practice in process troubleshooting. Combined academic studies, applied concepts, continued education and extensive pharmaceutical experience allow to be a resource. Fungi (molds & yeast) and bacterial contamination issues have been addressed many times with excellent results. Consultant on disinfection/ disinfectants validation. Conferences on fungi taxonomy, environmental monitoring, BET, water systems, bacterial taxonomy, etc. This include the University of PR, Mayagüez, Campus.
Experience as microbiology profesor at Sagrado Corazón University.
TECFAR offer diverse services & best equipment in class to assure your investment & team objectives.
Equipment •Modular Clean Rooms (pioneers world wide) •Isolators •ICOS Autoclaves & Ovens •Machine parts and glassware washers; tanks washing tunnels •All solid dosage process equipment •Stoppers Processors/ Sterilizer •Ethylene Oxide Sterilizers Services •Qualification & Validation Services •Engineering/ Process Projects •E-Beam Technology Qualification •Pharmaceutical Microbiology •SOP’s - better understanding, faster reading (photo-reading elements) & higher compliance assurance •Personnel - a diversity of professionals according to your needs •Audits •Trainings Isolators - Containment •MFG/ distribute CAPSUM custom containment - isolators •Optimize decontamination cycles (any brand) •Preventive maintenance/repair (all brands) •CAPSUM systems are top quality, at competitive prices. Can be build in Puerto Rico or Minnesota; they met or exceed applicable standards.
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