Aseptic Processing Course: Sterile Manufacturing for Biotech & Pharma

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    "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

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    "This the 2nd CfPIE course I’ve attended and they are excellent. I have scheduled my staff for several other CfPIE courses."


    Debbie R., Sr. Mgr. Quality Assurance, American Regent

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    "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

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    "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

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Course Director

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Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

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Aseptic Processing & Sterile Manufacturing Training Overview

Whether for biopharmaceutical or pharmaceutical applications, CfPIE's 15-hour sterile manufacturing course covers the technical basics that govern aseptic processing and provides practical advice to help attendees troubleshoot and manage their aseptic operations. Attendees from the sterile medical device industry have also benefited from this training.


The curriculum goes beyond theory by integrating real-world case studies and aseptic deviation investigations. Participants will explore practical scenarios that challenge their understanding of contamination control, allowing them to apply regulatory principles directly to their daily facility operations. This hands-on approach ensures concepts like "sterility assurance levels" translate into actionable floor practices. Although this aseptic training course emphasizes industrial microbiology, various types of sterilization and facility design fundamentals are presented in the context of regulatory compliance, Good Manufacturing Practice (GMP), and FDA/international current thinking.


Please be aware that this course is designed to address the standard aseptic filling process for biotech and pharmaceutical products. It does not address formulation development, cell culture, fermentation, preparative separations, or similar upstream or downstream processes.

Why Aseptic Processing Training is Essential for Compliance

Aseptic processing stands as the highest-risk operation in pharmaceutical manufacturing. A single lapse in technique or facility control leads to product contamination, costly recalls and patient harm. This course provides the foundational knowledge needed to minimize bioburden and ensure sterility assurance.


Furthermore, regulatory bodies such as the FDA and EMA continually evolve their expectations for clean room operations. Staying current with these shifts is critical for compliance. This training equips biotech and pharmaceutical professionals to navigate the complex global regulatory landscape with confidence, ensuring their facility's operations remain inspection-ready and efficient while prioritizing patient safety above all else.

Who Should Attend This Aseptic Training Program?

The course is for people who need to understand the technical fundamentals of aseptic processing, or for those responsible for aseptic operations in a lab, pilot or commercial setting. This aseptic training course is ideally suited to industrial microbiologists, scientists and engineers with either technical or managerial responsibilities in the biotechnology and pharmaceutical industries.


Specific roles that benefit from this curriculum include:

  • Production supervisors and managers
  • Process engineers
  • Validation specialists
  • Quality control analysts



It is also highly valuable for quality assurance professionals who oversee therapeutic product method validation or biopharmaceutical testing validation, but need a deeper understanding of the manufacturing environment.

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Aseptic Processing Learning Objectives and Agenda

  • Learning Objectives

    The primary goal of this course is to bridge the gap between microbiological theory and manufacturing reality. By grasping these objectives, participants will be able to identify potential contamination vectors, design more robust process simulations and defend their sterility assurance strategies during regulatory inspections.


    During and upon completion of this course, participants 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.

  • Agenda


    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

    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

  • Testimonials

    "The course was well structured and went just enough in-depth to get a lot of good information without getting too overwhelming.  The tables and case studies at the end were beneficial."

    Mike B., Sterility Assurance Specialist, Medline Industries


    "This course was very relevant, and I found the material focused and directly applicable. The content was organized is a way that more directly matched the title and course objective, some other courses I feel go to broad and cover too many topics at a very high level.  The depth on facility build out, levels of rooms and requirements, and the deep dives on autoclaves and machinery very relevant to my company environment."

    Marc K., SVP, Enterprise Operations, Revance Therapeutics


    "I really enjoyed this course! It covered all aspects of aseptic processing with good case studies/examples. Instructor was engaging and knowledgeable."

    Veena P., Associate Director, Drug Product Development, CMC, Cerus Corp.


    "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


    "The director had a strong relevant knowledge of the industry and was very helpful addressing my issues. He was also very engaging and facilitated the exchange of information among the attendees."

    Guy S., Senior Aseptic Manufacturing Svpr., Celgene


    "Course director was able to focus in on my area/job function within the material presented."

    Jacky Q., Clinical Supplies Specialist, CMC, Santen


    "The course was very comprehensive and the Course Director explained everything very clearly."

    Dr. Sivan P.E., Technologist, Biovac


    "Very informative and engaging discussions throughout."

    Sheetal M., Mfg. Associate Director, Ferring Pharmaceuticals


    "This the 2nd CfPIE course I’ve attended and they are excellent. I have scheduled my staff for several other CfPIE courses."

    Debbie R., Sr. Mgr. Quality Assurance, American Regent


    "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

FAQs

  • 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 course deal with FDA requirements?

    Since most attendees are from companies that export, the course covers global aseptic requirements, including those from the FDA, Europe and Canada, which are each more rigorous in specific areas.

  • Does this course cover lab assay validation?

    No. This course focuses on manufacturing sterility. For training on biological assay validation techniques, CfPIE offers an immunoassay validation course, which covers analytical methods in depth.

Strengthen Your Facility’s Sterility Assurance

Gain critical knowledge in managing aseptic risks to protect both your products and patients. Add this course to your cart and join our next livestream training session. Do you need to train your manufacturing staff? Call our team at 610-648-7550 or contact us online to discuss group rates.

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