ISPE LA - Building Management System
and Environmental Monitoring System
with Tour of B. Braun Medical

Sponsorships Available

B. Braun Medical
2525 McGaw Ave., Irvine, CA 92614

Host and Program Manager:
Ed Smith, Manager, Project Management, B. Braun Medical

Program Manager:
Merritt Postma, Director, Western Region, SKAN US

David Crance, Life Sciences Sales Manager, Particle Measuring Systems
Rafael Gilot, PE , Associate Director of Automation, B. Braun Medical
Michelle Luppino, PE, Account Executive, Siemens
Jay Miller, PE, Sr. Engineering Specialist, B. Braun Medical
Paul J. Smith, PE, Business Lead Biotech, Life Sciences and Healthcare, Siemens

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Environmental Monitoring System (EMS) provides management and user interface required for the clean room area's environmental monitoring system, data collection, reporting and historical functions for associated systems.

The idea is to bring the monitoring of existing cleanrooms (temperature, humidity and directional airflow) into a centralized control system. The system will encompass but is not limited to air handlers and dehumidifiers. The EMS will have expandable capability.

  • Key Elements include but are not limited to:
  • 21 CFR Part 11 (Electronic Records and Electronic Signatures) compliant
  • User Access and Levels i.e.
  • Administrator Access /Operator Access
  • Maintenance Access / Supervisor Access
  • Backup and Restore
  • Historian and Reports

This meeting will also include a tour of the mezzanine showing B. Braun Medical's Environmental Monitoring System. It will not include production areas.

Closed toe shoes are mandatory and photo ID will be required for security check in.

Event Details

About the Speakers:

David Crance is the Life Sciences Sales Manager for Particle Measuring Systems and has been in the Life Sciences business for over 30 years. He has lectured for pharmaceutical societies and organizations throughout the USA and Asia on environmental monitoring systems and their cGMP regulations. He has been an Instructor at the Parenteral Drug Association (PDA) headquarters in Bethesda, Maryland for the last fourteen years. David has been involved in the design and implementation of almost 500 environmental monitoring systems. In his role as Life Sciences Sales Manager, he works with leading engineering firms and manufacturers in the designing of Environmental monitoring systems.

Rafael Gilot, PE is the Associate Director of Automation at B. Braun Medical. He has experience in the pharmaceutical industry covering the areas of sterile product, Active Pharmaceutical Ingredients (API), solid dosage, utilities and biotech. His expertise is in process control, automation and project management.

He had held automation, engineering and validation positions at GSK, Baxter and Pfizer. He has a bachelors degree in mechanical engineering from Polytechnic University of Puerto Rico.

Michelle Luppino, PE is an Account Executive at Siemens in Cypress. After receiving her BS in Engineering Physics at UC Berkeley, Michelle started at Siemens at an Engineering Specialist. She has had several engineering positions with Siemens over the past 12 years.

Her expertise includes Building Automation (BAS) and Environmental Monitoring (EMS). She has worked with pharmaceutical, biotech and universities ensuring their labs and cleanrooms are in compliance. She is a new ISPE LA Member!

Jay Miller, PE is a Senior Automation Engineer at B. Braun Medical. He has 18 years of experience in automation and controls. In addition to work in the pharmaceutical industry, he has also worked in oil and gas, chemical, food, water and waste water. He has a BS in Electrical Engineering and an MS in Engineering Management from University of New Orleans.

Paul J. Smith, PE is a Business Lead for Biotech, Life Sciences and Healthcare for Siemens in Cypress. He is currently involved with Business Development, Compliance Assessments, Construction Planning, Engineering, Environments of Care, OSHPD Compliance Standards, Account Management, Project Budgeting/Scheduling, Reimbursement, Digital Health and IT Security.

He has a BS in Electrical Engineering from Cal Poly San Luis Obispo and a MBA from Pepperdine Graziadio School of Business and Management. He has been in the automation and controls industry for 29 years. He has been an ISPE Member for 20 years.

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