Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products

Course Agenda

First Day

Module 1

• Facility Design
  • Grades A-D
  • gowning
  • crimping

Module 2

• Environmental Monitoring

Module 3

• Risk Management

Module 4

• Equipment
  • sanitary design
  • isolators
  • disposables
  • blow-fill-seal

Module 5

• Containers
  • vials stoppers seals
  • siliconization
  • manual & automatic visual inspection
  • pre-filled syringes

Module 6

• Package Integrity
  • leakage
  • sterility test
  • parametric release

Second Day

Module 7

• Autoclaves
  • lethality, f0, & log reduction
  • types of cycles
  • validation

Module 8

• Depyrogenation

Module 9

• Radiation

Module 10

• Ethylene Oxide

Module 11

• Lyophilization

Module 12

• Spray Drying

Module 13

• Disinfectants and Antiseptics

Module 14

• Water & Pure Steam

Module 15

• Media Fills

Module 16

• Filtration
  • liquids & gases
  • validation

Learning Objectives

During and upon completion of this course, you will:

• Understand fundamental aseptic facility design principles
• Appreciate what the Food and Drug Administration (FDA) expects of an aseptic filling operation including key differences in other regulated markets
• Better understand aseptic container-closure systems and leak testing
• Know how to properly check equipment and systems in preparation for processing via process simulations - media fills
• Learn the difference between aseptic processing and terminal sterilization
• Learn about the importance of an environmental monitoring program
• Understand the technical fundamentals behind filter sterilization
• Begin to apply risk management strategies to aseptic operations
• Be in a better position to manage your clean room operations
• Appreciate the difference between isolators and barriers
• Know more about lesser-used techniques in aseptic processing
• Understand autoclave cycles and microbiological lethality
• Know about dry heat sterilization and depyrogenation
• Understand gamma and beta radiation sterilization
• Learn about ethylene oxide sterilization
• Know the basics of lyophilization - freeze drying
• Learn where cleaning validation fits in
• Learn about the various types of pharmaceutical water, including water for injection; pure steam generators
• Understand how validation concepts are inter-woven
• Receive practical tips on how to manage your aseptic operations

Testimonials

"One of the best, if not the best course I’ve taken! I really enjoyed the case studies and interaction between teams and the instructor." James B., Bioengineering Advisor, Noblis ESI

"Very informative. I enjoyed the way the instructor was able to engage the participants." Lackram P., Mfg. Process Engineer, Luitpold Pharmaceuticals

"The instructor was very knowledgeable and friendly! Great course director. He loved to make diagrams. The visualization helped with various topics." Tanya K., Chemist I, Sigma Aldrich

"This was an excellent training course due to the instructor’s depth of knowledge and the material presented." Hemant P., Sterility Assurance Coordinator, Luitpold Pharmaceuticals

"It was an excellent presentation that was highly interesting!" Amanda E., Process Development Scientist, Sigma Aldrich

""Easy to follow along; great details and easy to understand visuals." Doug W., Chem Processor 3, Sigma Aldrich

"Thank you very much for a well presented and well taught course on aseptic processing on October 27 and 28, 2014. I came away with a very fundamental and historical understanding of the ABC of aseptic processing that will, for sure, enable me to move to the next level. I just want to sum up my learning experience in three words: "exceeds my expectation". Rith T., Manager, R&D, BBraun Medical

"This course is extremely helpful to understand the various principles of Aseptic Processing. The Course Director is very knowledgeable and is patient and answered every single question. The course material is appropriately updated, considering the current industry practices. I highly recommend this course for anyone who works in the field of cGMP manufacturing." Suresh B., Manufacturing Supervisor, BioMARC

"The Course Director was extremely knowledgeable in first hand illustrations of problems and cases. Humorous and poignant delivery. He was very flexible regarding demands and inputs of the specifics desired by the participants. The Course Director was thorough and precise." Justin N., Production Specialist, Vitrolife

"The instructor was well organized, good flow of material. A lot of good information in the hand-outs and good use of case studies to back up information being presented." Kevin M., Project Manager, Commissioning Agents

"Good technical overview given without going into too much detail - questions were encouraged and answered satisfactorily if extra detail was required by attendees." Brian O., QA Validation Specialist, Pfizer

"The course notes were very detailed and the instructor very knowledgeable. The material covered will be of immediate use to me when I return to work." David I., QA Associate, J&J

"The instructor was energetic and engaging! The material was more relevant than I had expected - an excellent training course for aseptic processing!" Kent V., Sr. Validation Specialist, Genentech

"The instructor knows the material very well, is up-to-date on FDA regulatory issues with Aseptic Processing and presented very well!" Mark G., Senior Manager, Pfizer

"The course and Director were excellent. The binder was useful and will be a great reference in the future!" Gil E., Quality Systems Manager, Biomimetics Therapeutics

"The Course Director was very knowledgeable and used a number of real like examples. He was also very good in encouraging team discussions. The case studies were also very useful. This is the best Aseptic Processing training course I have ever taken!" Arun S., Engineering Supervisor, Emergent Biosolutions

"Excellent training! The trainer has a deep understanding of the topic and did a great job. The use of training aids was awesome. Overall it was a great training session. One of my friends referred me, and I came from the west coast to attend the course. I am glad that all of my expectations were met!" Vivek V., Manager, Hollister Stier

Frequently Asked Questions

What level of complexity is this course?

This course is designed for people working in sterile aseptic processing in the pharmaceutical, biological and, very often, medical device industries. Attendees at the supervisory, management, and director levels find the most benefit because the underlying risks and reasons for the way things are done are explained.

Is it all lecture, all "hands on," or a mixture?

It is classroom lecture style, not "hands on," although there are frequent breakout sessions for groups to work on case studies such as aseptic deviation investigations and risk-based approaches.

How much microbiology do I need to know? Are there any other prerequisites?

Attendees need not know any microbiology but need to have an interest in learning at least the basics since such knowledge is needed to understand aseptic processes. Attendees should also come with a good understanding of pharmaceutical GMP as that will be taken for granted. You should also be aware of the major aseptic processes and which ones are used in your company such as steam, water, dry heat, ethylene oxide, radiation, lyophilization, filtration, and/or disinfection.

Will this deal with FDA requirements?

Since most attendees are from companies that export, the course deals with GLOBAL aseptic requirements including FDA, Europe, and Canada, which are each more rigorous than the others in specific matters.