Packaging Line Engineering and Operations for the Pharmaceutical and Similar Industries

Dr. Timothy D. Blackburn, MBA, P.E.

Course Outline

This course will address the fundamentals (but comprehensively) of packaging line engineering and operations, focusing on the Pharma but relevant to similar industries. Although not intended to be a highly technical course on machine design or sophisticated controls, we will explore the essential elements of understanding integrated packaging engineering and operations necessary for the engineer involved in the industry. The perspective of the course is from the specifier's point of view primarily, and less the machine designer.

This course includes a multiple choice quiz at the end, which is designed to enhance the understanding of the course materials.

Learning Objective

Upon completion of this course, the student should have a basic understanding of the following concepts related to Packaging Line Engineering and Operations:

• Understand elements behind drivers for justifying a packaging line project;
• Explore ways to meet the need for improvement or a new line;
• Review packaging components;
• Review typical machine centers;
• Understand equipment cleaning considerations;
• Safety for product and employees;
• Review technologies;
• Utilities required for a line;
• Calculate line and machine center performance requirements;
• Space Planning considerations;
• Planning and Project Management;
• Specifications and Design documents, such as FRS, URS, etc.;
• Considerations for effective bid packages;
• Things to consider for contracts;
• Delivery methodologies;
• Start-up, Commissioning, and Validation;
• Closeout and Operation;
• Documentation;
• Training and Qualified Workforce;
• Standard Operating Procedures (SOP);
• Maintenance/PM's;
• Lifecycle management; and
• Decommissioning.
  
  

Intended Audience

The intended audience includes anyone interested in learning more about Packaging Line Engineering, especially for the Pharmaceutical Industry. Meant to be an introduction for the non-packaging engineer, the packaging engineer unfamiliar with the Pharma industry will benefit as well. In addition, any professional involved in planning a Pharma facility will benefit including Architects.

Benefit to Attendees

Understand the fundamentals, yet comprehensive, elements of Packaging Line Engineering. Also, the attendee should be able to calculate the fundamental performance elements of a machine center. In addition, the attendee should be better equipped to integrate packaging elements into the overall design.

Course Introduction

Production that is automated is essential in today's environment, with packaging lines being a prime example of this technology. Do packaging operations fascinate you but seem to be too far removed from your experience to be understandable? Would you like to know more about the fundamentals of packaging engineering operations? Or are you already familiar, but would like to understand its application to the Pharma industry? This course will cover the fundamentals of this subject, focusing on the Pharma but relevant to similar industries. Although not intended to be a highly technical course on machine design and sophisticated controls, we will explore the essential elements of understanding integrated packaging engineering and operations necessary for the engineer involved in the industry. The perspective of the course is from the specifier's point of view primarily, and not the machine designer.

Course Content

The course content is in a PDF file (64 KB) Packaging Line Engineering and Operations for the Pharmaceutical and Similar Industries.

Please click on the above underlined hypertext to view, download or print the document for your study. Because of the large file size, we recommend that you first save the file to your computer by right clicking the mouse and choosing "Save Target As ...", and then open the file in Adobe Acrobat Reader. If you still experience any difficulty in downloading or opening this file, you may need to close some applications or reboot your computer to free up some memory.

 

Course Content

1. Equipment Justification

a. Cost of goods
b. Meet volume
c. Reduce labor/payback
d. Example of cost/payback analysis
e. Safety or Regulatory need
f. Utilization
g. Flexibility

2. Ways to meet the need

3. Packaging components

a. Primary

i. Bottles/caps
ii. Tubes
iii. Thermoform
iv. Form-Fill-Seal (FFS)
v. Pouch
vi. Other
vii. Sterile

b. Labels
c. Secondary
d. Tertiary

4. Typical Machine Centers

a. Primary packaging components and product introduction
b. Product fill
c. Product Enclosure
d. Product Labeling
e. Date and lot coding
f. Secondary packaging (Cartons, etc.)
g. Conveyance
h. Other

i. Autoclave
ii. Lyophilizers
iii. Blow/Fill/Seal
iv. Sterilizers
v. Vision systems
vi. Printers
vii. Accumulation
viii. Reject
ix. Glove box/Isolators

1. Restricted Access Barrier System (RABS)

x. Inserts
xi. Coupons
xii. Check weighers
xiii. Metal detectors
xiv. Robotics

5. Equipment Cleaning

6. Safety

a. People Safety

i. Machine guarding, pinch points
ii. Safety-conscious controls
iii. Ergonomics
iv. Dust explosions
v. Flammables
vi. Potent compounds
vii. PPE

b. Protecting the product

i. From the environment
ii. From people
iii. Aseptic/sterile
iv. Line clearance

7. Technologies

a. Controls PLC's/SCADA
b. Robotics
c. Typical machine design considerations
d. Rotary versus Straight Line
e. Custom Machinery
f. Filler Technology
g. Specification Checklist Utility Support

8. Utilities

a. Utility Matrix
b. Electricity
c. Compressed Air
d. Other gasses (ex. Filtered Nitrogen)
e. Hot/cold water
f. Clean steam
g. Purified Water or Water for Injection (WFI)

9. Determining Line Capacity

10. Space Planning

a. Adequate space
b. Separation
c. Material supply
d. Ancillary functions
e. Facility protection

i. Fill suites
ii. Clean Rooms
iii. General facility considerations

f. HVAC
g. Lighting
h. Architectural finishes

11. Planning and Project Management

12. Specifications and Design

a. URS
b. FRS
c. Design Spec

13. Effective Bid packages

14. Contracts

15. Delivery methodologies

a. Reuse
b. Self-managed
c. Integrator
d. Prime Vendor
e. Combine with A/E contract .
f. Design-Build
g. Construction Management
h. Self-constructed

16. Start-up, Commissioning, and Validation

a. Start-up
b. SAT/FAT's

i. Factory Acceptance Tests (FAT)
ii. Site Acceptance Tests (SAT)
iii. Integrated Acceptance Test (IAT)

c. Commissioning and Validation

17. Closeout and Operation

18. Documentation

19. Training and Qualified Workforce

20. Standard Operating Procedures (SOP)

21. Maintenance/PM's

22. Lifecycle management

a. TPM (Total Productive Maintenance)
b. Continuous improvement

i. OEE
ii. 5S

c. Calibration/PM's
d. Decommissioning

Course Summary

In this course, we study the fundamentals of packaging line engineering and operations for the Pharmaceutical and related applications. In the beginning, we review the business and regulatory drivers and considerations for initiating a Packaging Line project. In addition, this course includes an overview of packaging components, equipment machine centers, and other practical approaches for implementing a packaging engineering project. General space planning issues are discussed. Methods of determining line speed are reviewed. Finally, lifecycle considerations are discussed.

Quiz

Once you finish studying the above course content, you need to take a quiz to obtain the PDH credits.

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DISCLAIMER: The materials contained in the online course are not intended as a representation or warranty on the part of PDH Center or any other person/organization named herein. The materials are for general information only. They are not a substitute for competent professional advice. Application of this information to a specific project should be reviewed by a registered architect and/or professional engineer/surveyor. Anyone making use of the information set forth herein does so at their own risk and assumes any and all resulting liability arising therefrom.

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