Course_Outline - Sublimation Science

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Improving the Performance of your Lyophalization System
Giving you the A to Z on the PAT!
Improve Your Ability To:

Increase the productivity of your Lyophilization system and avoid
expensive batch contamination.

Improve the performance of your Lyophilization technology and
increase stability and shelf life of your product.

Communicate effectively with other departments and team members to
streamline your workload

Handle scale up issues associated with Lyophilization to get your
product to market faster

Interpret the PAT and know what the FDA will look for when analyzing
your Lyophilization system and avoid costly delays.

Keep your system running smoothly by updating outdated equipment
and understanding the validation requirements
Who Should Attend:
This course is intended for both new and experienced professionals within the
Pharmaceutical and Biologic Industry. Specifically, the following job functions would
benefit from taking this course:




Process Engineers
Formulation Scientists
Validation Engineer
Validation Scientist




Process Supervisor
Chemical Engineer
Manufacturing Manager
Production Manager
Course Description:
Lyophilization is a complex science, and finding the practical, hands on
knowledge you need is difficult. This two day course will provide much needed
information to industry professionals dealing with the formulation, processing,
and manufacturing of Lyophilized products. From complying with current
regulations to developing a more efficient process, Improving the Performance of
your Lyophalization System is the perfect opportunity for you to learn more than
what is in a textbook.
By integrating case studies, interactive, exercises, and lively discussion,
participants will return to work with the knowledge you need to increase
productivity and be confident in your “fill to finish” approach to Lyophilization.
Agenda - Day One
I. Examine the Fundamentals of Lyophilization (1.5 hours)
a. Explain current state of affairs
b. Examine the essential elements of Lyophilization
c. Define key stages, terms and definitions
Discussion: Review Participants Background with Lyophilization (0.5 hours)
II. Examine Regulatory Issues (1.5 hours)
a. Product End Test Requirements
i. <1> Injections
ii. <905> Uniformity of Dosage Units
iii. <85> Bacterial Endotoxin
iv. <921> Water Determination
v. Elegance?
vi. Stability
b. Machine Requirements
i. Sterility
ii. Leak tests
iii. What cycle variance is tolerable?
c. Cleaning
i. TOC testing
ii. Release criteria
d. Event Recovery: Handling issues
Exercise: Critique a Case Study and Discuss Preventative measures (0.5
hours)
III. Aseptic Processing (1 hour)
a. Autoloaders
b.
c.
d.
e.
SIP & CIP
Pizza Doors
Isolators
General Process Design
IV. Use Process Analytic Technology: “Real time measurements determining
process control” (3/4 hour)
a. Thermocouple Data – Old and still useful
b. Pressure Hold methods
c. Manometric Temperature Measurement
d. Pirani gauge
e. Dew point indicator
f. Uses for NMR
g. Sample thieves
V. Optimizing the Process Cycle (1 hour)
a. Chemistry
i. Analytic techniques
ii. Which excipients and why
iii. Stability testing
b. Mechanics
i. Pressure
ii. Temperature
iii. Time
VI. Improve the Throughput of Your Lyophilization System (1 hour)
a. Implementing complete cycle optimization
b. Reaching maximum capacity/capability
Agenda - Day Two
VII. Scale Up – From Pilot to Production (1 hour)
a. Using the Collapsed Temperature formulation
VIII. Design (1 hour)
a. Refrigeration
b. Vacuum
c. Control systems
d. Shelf mechanics
IX. Validation (2 hour)
a. Formulation
b. Freeze Drying Cycle
c. Freeze Dryer
X. Buying a New Lyophilizer (2 hours)
Analysis & Discussion of a URS (one can be handed out and this
can be a group discussion session).
XI. Trouble Shooting (1 to 2 hours)
a. Dealing With:
i. Proven Acceptable Range
XII. Meeting Review and Close
Exercise: Examine Key Points from the past two days of training
NOTES:
I.
II.
III.
IV.
V.
VI.
Regulations: Guide To Inspections of Lyophilization of Parenterals
Automation
Miniaturization
Batch Process Vs. Continuous Process
Advances in Technology
PAT
as a guide for scale up, setting those parameters would reduce time.
Examine the Fundamentals of Lyophilization
Explain Current Stat of Affairs
Examine the essential elements of lyophilization
Define Key Stages, Terms and Definitions
Discussion: Review Participants Background with Lyophilization
Examine the Regulatory Requirements for Lyophilization
Improving your Filling Accuracy
The Non Contact Check Weigher (NCCW)
Exercise: Critique a Case Study and Discuss Preventative measures
Communicate with Key Departments
Define Roles and Responsibilities
Optimize communication among all personnel involved in Lyophilization
Optimizing the Process Cycle
Improve the Throughput of Your Lyophilization System
Implementing Complete Cycle Optimization
Reaching Maximum Capacity/Capability
Scale Up – From Pilot to Production
Use PAT to Develop
Understanding your Company’s PAT Program
Validation
Formulation
Freeze Drying Cycle
Freeze Dryer
Trouble Shooting
Dealing With:
Proven Acceptable Range
Meeting Review and Close
Examine Key Points from the past two days of training
Implement Best Practices for Lyophilization Techniques
Prevent Lost Batches
Streamline your Process
Accurately Report Your Progress
Stopper Selection
Assess Your Product’s Stability
Analytical Techniques
Practical Applications
Speed Up Your Process
Micro
Containers and Stoppers
Improving your Cycle Development
PAT
Process Capability Approach for Lyophilized Proteins and Biologics
Each lyophilization cycle is a specific set of PLC set points in time for chamber
pressure and shelf temperature. However, lyophilizers are a complex system of
heaters, pumps, compressors, and control systems. As such, they do not operate
at the specific set points, but rather vary over a finite range around these set
points. While it is not possible to test each of the possible combinations, an
envelope of upper and lower limits can be defined.
David A. Hamilton, M.S. Ch.E., Manager Pharmaceutical Technology Transfer,
Schering-Plough Corporation, Singapore
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