| Description
Effective Generation and Supply of High Quality Critical Utilities is
paramount to success in the BioPharmaceutical Industry. Key to this success
is dependable operation of their Clean Utilities systems, increased system
life, and minimization of maintenance and nonconformance events.
This seminar will
focus on those factors which can most influence the successful management
of the BioProcess Utility Assets within these operating plants. Design,
Operation and Maintenance best practices will be stressed, by reviewing
regulatory requirements, actual case studies, and the engineering concepts
to increase long-term asset value.
What you will Learn
- Worldwide
Regulatory requirements for Utility Systems.
- Operational
requirements for long term service of specific types of Utility Systems
equipment.
- Design
and Material selection considerations for long term service of Utility
systems, and their potential to impact on the process equipment.
- End User
perspectives in the operation and management of Utilities Systems including
recent trends and developments.
- Network
with industry peers, share knowledge and experience
Who
Should Attend
This course should be useful for utility engineers, utility operators,
maintenance engineers, reliability engineers, process engineers, facility
engineers, validation engineers, quality assurance staff, project managers,
and maintenance technicians, with 2-8 yrs of experience in manufacturing
and operation, engineering, validation, quality assurance.
Instructor/Speaker
Panel:
-
Seminar
Director: James Dean Vogel,
P.E., Principal and Owner, Process Facilities Services
-
Peter
Petrillo,
Principal and Owner, Millennium Facilities Resources
-
Ibrahim
Khadra,
Staff Process Engineer, World Wide Engineering, GPSC, LLC, (Johnson
and Johnson)
-
Katrin
Åkerlindh,
Global Product Manager - Specialty Gases, Linde AG
|
Monday,
June
14 |
| 8:00
am - 8:15 am |
Opening
Remarks
-James Dean Vogel, P.E., Principal
and Owner, Process Facilities Services |
| 8:15
am - 10:00 am |
Overview
of Facility Utility Design and Operation for BioPharmaceutical Production
Utility design and operation strategy will be reviewed. Master
Planning, Change Management and integration fo retrofit projects will
be stressed. Interactions with support utilities will be defined,
and comparisons between large sites and small start-up facilities
will be covered.
-James Dean Vogel, P.E., Principal
and Owner, Process Facilities Services |
| 10:00
am - 10:30 am |
Coffee
Break |
| 10:30
am - 11:00 am |
Compendia
Requirements for Clean Utilities
Review the general requirements, compare US, EU and others. (Water,
Steam, Process Gasses, HVAC, CIP, Liquid Nitrogen)
-James Dean Vogel, P.E., Principal
and Owner, Process Facilities Services |
| 11:00
am - Noon |
Overview
of Design and Operation of Pretreatment Water systems
Review the general requirements for design, operation and verification.
-Peter Petrillo, Principal and
Owner, Millennium Facilities Resources |
| Noon
- 1:00 pm |
Lunch |
| 1:00
pm - 2:00 pm |
Design
and Operation of Water For Injection systems
Review the general requirements for design, operation, distribution,
verification and validation.
-Ibrahim Khadra, Staff Process
Engineer, World Wide Engineering, GPSC, LLC, (Johnson and Johnson)
|
| 2:00
pm - 3:00 pm |
Design
and Operation of Clean Steam systems
Review the general requirements for design, operation, distribution,
verification and validation.
-Ibrahim Khadra, Staff Process
Engineer, World Wide Engineering, GPSC, LLC, (Johnson and Johnson)
|
| 3:00
pm - 3:30 pm |
Coffee
Break |
| 3:30
pm - 4:30 pm |
Stainless
Steel Lifecycle and Rouge
A review of Stainless Steel, its make-up and its applications in the
BioPharmaceutical Utilities. Attention will be on evaluating length
of service. Rouge, evaluation of its formation and methods of prevention
and remediation will be discussed.
-Peter Petrillo, Principal and
Owner, Millennium Facilities Resources |
| 4:30
pm - 5:00 pm |
Clean
Utility Nonconformance Review
A review of actual Nonconformance events from Clean Utility systems.
-James Dean Vogel, P.E., Principal
and Owner, Process Facilities Services |
|
Tuesday,
June 15 |
| 8:30
am - 10:00 am |
Design
and Operation of Clean Air Systems
Review the general requirements for design, operation, distribution,
verification and validation. Process Air vs. Instrument Air and Filtration
will be reviewed.
-Katrin Åkerlindh, Global
Product Manager - Specialty Gases, Linde AG |
| 10:00
am - 10:30 am |
Coffee
Break |
| 10:30
am - 11:15 am |
Design
and Operation of Process Gas Systems
Review the general requirements for design, operation, distribution,
verification and validation. Liquid Nitrogen, Life and property safety
and Filtration will be reviewed.
-Katrin Åkerlindh, Global
Product Manager - Specialty Gases, Linde AG |
| 11:15
am - Noon |
Materials
of Construction for Clean Utility Systems
Review the general requirements for design, operation and verification.
-Peter Petrillo, Principal and
Owner, Millennium Facilities Resources
-James Dean Vogel, P.E., Principal and Owner, Process Facilities Services
-Ibrahim Khadra, Staff Process Engineer, World Wide Engineering, GPSC,
LLC, (Johnson and Johnson) |
|
Noon - 1:00 pm |
Lunch |
| 1:00
pm - 2:00 pm |
Plastic
and Elastomer Lifecycle
A review of polymers their make-up and their applications in the BioPharmaceutical
Industry. Attention will be on material selection and evaluating length
of service.
-James Dean Vogel, P.E., Principal
and Owner, Process Facilities Services |
| 2:00
pm - 3:00 pm |
Asset
Management Techniques
Review of methods to manage a plant’s assets, and how they all
fit together. Electronic Document Management Systems, CADD drawing
files, Equipment Files, Computerized Maintenance Management Systems,
Building Management Systems,
-James Dean Vogel, P.E., Principal
and Owner, Process Facilities Services |
| 3:00
pm - 3:30 pm |
Coffee
Break |
| 3:30
pm - 4:30 pm |
Work
Shop-Evaluate your data, Write you procedures, and Summarize your
system performance
An interactive workshop where the class will break into groups and
generate operational and Maintenance programs and procedures. They
will function under a simulated project and facility operation scenario.
Write your procedures and evaluate the data.
-James Dean Vogel, P.E.,
Principal and Owner, Process Facilities Services
-Katrin Åkerlindh, Global Product Manager - Specialty Gases,
Linde AG
-Peter Petrillo, Principal and Owner, Millennium Facilities Resources
-Ibrahim Khadra, Staff Process Engineer, World Wide Engineering,
GPSC, LLC, (Johnson and Johnson) |
| 4:30
pm - 5:00 pm |
Case
Studies and Panel Discussion
Review of actual case studies, Regulatory citations and recent trends
and developments regarding Operations and Maintenance of Critical
Utility Systems.
- Panel |
| 5:00
pm - 7:00 pm |
Cocktail
Reception (with Exhibitors) |
| Wednesday,
June 16 |
|
8:00
am - Noon |
Application
of ASME Bioprocessing Equipment (BPE) Standard
Separate registration required. Click
here for more
details |
|
1:00
pm - 5:00 pm |
ASME
BPE Committee Meetings (June 16-18). Open to the public.
No registration required. |
REGISTER NOW!
Visit www.asmeconferences.org/Bioprocess10
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. |
