Home
Schedule
Meeting Information
Hotel Information
Instructors Only
Contact Us



 
Program
Keynote
Plant Tour
Exhibitors
Sponsors
Media Partners

ASME Contact:
Jennifer Delda
Program Manager
212-591-7108
deldaj@asme.org



 


PD483: Cleaning Practices: Practical Implementation of CIP for Success


This course is now available on CD-ROM. To purchase, please call 800-843-2763.

 



Description


In critical Bioprocessing and containment environments, Clean-In-Place (CIP) technology is an increasingly vital part of our manufacturing facilities and systems. Application of CIP equipment and systems without consideration of a number of critical factors, and consideration of the processes as a whole, can negatively affect plant functionality and flexibility, despite incorporation of the latest technology. This course will establish fundamental concepts of cleaning mechanisms & chemistry, CIP skid design, distribution systems, equipment design for CIP along with in-depth cleaning validation guidance and regulatory considerations.

What You Will Learn

  • Understand and apply basics of cleaning mechanisms and chemistries for soil removal.
  • CIP system design for various skid and distribution system configurations.
  • Equipment design principles for effective CIP.
  • Cleaning validation principles and practices of cleaning validation.


Who Should Attend

This course is intended for professionals involved in the design, operation and validation of bioprocess systems that require a high degree of sanitation. Materials presented in the course will be of benefit to process, project, facilities and validation engineers, technicians, manufacturing managers and supervisors, quality assurance scientists and regulatory personnel.


Schedule

Sunday, October 22, 2006
5:00 pm - 8:30 pm Registration Open - Avoid the lines on Monday!
Monday, October 23, 2006
7:30 am - 8:30 am Registration Desk Open / Continental Breakfast
4:30 pm - 5:30 pm KEYNOTE Presentation
5:30 pm - 7:00 pm Opening Reception w/ Exhibitors
Tuesday, October 24, 2006
7:30 am - 8:30 am Registration Desk Open / Continental Breakfast w/ Exhibitors
8:30 am - 9:00 am
Regulatory & Business Context
Why we care…. and how CIP may be of specific relevance to success or failure in biotech business.
Ryan Schroeder
Sr. Associate & Biotech Core Team Leader
CRB Consulting Engineers
9:00 am - 10:00 am CIP 101
Basic overview of CIP systems, fundamentals, and terminology.
Chris McNulty
Pharmaceutical/Biotech Product Manager
Sani-Matic Inc.
10:00 am - 10:30 am
Refreshment Break w/ Exhibitors
10:30 am - 12:00 noon
Principles of CIP-Cleaning Mechanisms
Focus on variables that lead to effective cleaning, including cleaning chemicals and mechanical action.
Chris McNulty
Pharmaceutical/Biotech Product Manager
Sani-Matic Inc.
12:00 noon - 1:00 pm
Lunch w/ Exhibitors
1:00 pm - 2:30 pm
CIP and Regulatory Compliance
Multi product vs. dedicated product facilities and batch-to-batch vs. campaign cleaning will be discussed in the light of various applications and regulatory requirements.
Rebecca Brewer
Director, Consultancy Services, Validation and GMP Compliance
Dober Group
2:30 pm - 3:00 pm
Refreshment Break w/ Exhibitors
3:00 pm - 4:30 pm
CIP System Design-Skids
CIP skid design considerations including single vs. mulit-tank configurations, typical CIP cycles and instrumentation philosophies.
Chris McNulty
Pharmaceutical/Biotech Product Manager
Sani-Matic Inc.
Wednesday, October 25, 2006
7:30 am - 8:30 am Registration Desk Open / Continental Breakfast w/ Exhibitors
8:30 am - 10:00 am Spray Devices and Vessel Cleaning
Basic principles of vessel cleaning, focusing on a review of various types of static and dynamic spray devices. Equipment applications and considerations for selection will be analyzed with respect to process variables and vessel configuration.
Chris McNulty
Pharmaceutical/Biotech Product Manager
Sani-Matic Inc.
10:00 am - 10:30 am
Refreshment Break w/ Exhibitors
10:30 am - 12:00 noon CIP Fundamentals for Piping Systems
Impacts of flow, velocity, dead-legs, circuit configuration to piping system CIP will be reviewed. Criteria for establishing circuit definition for complex piping systems, including valve and transfer panel configurations, will be presented.
Ryan Schroeder
Sr. Associate & Biotech Core Team Leader
CRB Consulting Engineers
12:00 noon - 1:00 pm
Lunch w/ Exhibitors
1:00 pm - 2:30 pm
CIP System Design- Distribution
CIP supply and return system approaches including transfer panels, valve matrices, facility and process integration.
Ryan Schroeder
Sr. Associate & Biotech Core Team Leader
CRB Consulting Engineers
2:30 pm - 3:00 pm
Refreshment Break w/ Exhibitors
3:00 pm - 4:30 pm
Qualification and Cleaning Validation - Part 1
Rebecca Brewer
Director, Consultancy Services, Validation and GMP Compliance
Dober Group
Thursday, October 26, 2006
7:30 am - 8:30 am Registration Desk Open / Continental Breakfast
8:30 am - 10:00 am
Qualification and Cleaning Validation - Part 2
Rebecca Brewer
Director, Consultancy Services, Validation and GMP Compliance
Dober Group
10:00 am - 10:30 am
Refreshment Break
10:30 am - 12:00 noon
In Process Control and Quality
Approaches to maintaining the validated state will be discussed relative to such items as routine monitoring, preventive maintenance, calibration, change control and revalidation.
Rebecca Brewer
Director, Consultancy Services, Validation and GMP Compliance
Dober Group
12:00 noon - 1:00 pm
Lunch
1:00 pm - 2:30 pm
Equipment Design for CIP-Bioreactors
Detailed review of a cleaning circuits for a "typical" large scale cell culture bioreactor. Participants will interactively discuss and evaluate CIP strategy at the PID level.
Ryan Schroeder
Sr. Associate & Biotech Core Team Leader
CRB Consulting Engineers
2:30 pm - 3:00 pm
Refreshment Break
3:00 pm - 4:00 pm
Integrating CIP into Complex Manufacturing Sequences
Examples which demonstrate the influence of cycle duration, circuit complexity and skid utilization on batch and sequential processing operations are discussed.
Ryan Schroeder
Sr. Associate & Biotech Core Team Leader
CRB Consulting Engineers
4:00 pm - 5:30 pm
PLANT TOUR: BRI Bioprocess Plant - 50 Maximum
Friday, October 27, 2006
9:00 am - 10:30 am
PLANT TOUR: BRI Bioprocess Plant - 50 Maximum

 


ASME Travel Policy : ASME is not responsible for the purchase of non-refundable airline tickets or the cancellation/change fees associated with canceling a flight. Please call to confirm that the course is running before purchasing airline tickets. ASME retains the right to cancel a course up until 3 weeks of the scheduled presentation date.





 
Produced By
 
 
ASME
 
Premier Media Sponsor
Corporate Sponsor
Supporting Organization
Supporting Publications
ASME Sponsoring Divisions 
           

Copyright © 1996-2008 ASME. All Rights Reserved. Terms of Use | Privacy Statement
Powered by Conference Toolbox ™ version 4.0. For more information, contact us.