trainings

Dates:  Aug 19 – 21, 2025

Location:  SKAN US HQ, Raleigh, NC

This 2.5 days course is an in-depth, hands-on training course on aseptic behaviors using isolators for sterile product manufacturing.  This course will provide comprehensive knowledge of proper aseptic processing behaviors to ensure contamination control.  

During this course, participants will learn about basics of microbiology, aseptic necessities during aseptic processing, basics of isolator technology, Vaporized Hydrogen Peroxide (VHP) decontamination and validation of isolators, FDA and EU (Annex 1) regulations for aseptic processing, environmental monitoring, isolator set-up and parts change over processing, proper aseptic movements in isolators, cleaning and disinfection of cleanrooms and isolators, gowning for aseptic processing in isolators, proper isolator glove use, isolator glove leak testing, sterile filtration of drug products/PUPSIT and risk assessments, aseptic processing simulations, intervention risk assessments, investigating APS failures, and air visualization studies in isolators.

At the end of the course, there will be an ask the experts session with the instructors as well as former FDA regulators from Jeff Yuen & Associates.

WHO SHOULD ATTEND

• Aseptic Processing Operators

• Manufacturing Supervisors, Managers

• Quality Assurance Specialists, Managers

• Contamination Control Strategy Specialists, Managers

Upon completion of this course, participants will be able to:

• Understand and interpret US and EU regulations on aseptic processing and isolators

• Describe isolator technology and how VHP decontamination and validation is performed

• Create a risk based environmental monitoring program for inside an isolator and its associated cleanrooms

• Perform handling of EM plates and swabs in isolator gloves

• Understand basic microbiology concepts and understand how contamination is controlled

• Develop a risk based aseptic processing simulation program 

• Perform an intervention risk assessment 

• Assess proper and improper aseptic behaviors in isolators

• Create and interpret air visualization studies for isolators

• Perform proper glove entry using isolator gloves

• Perform isolator parts change over properly for aseptic processing

• Describe how to properly clean, disinfect and surface decontaminate an isolator

• Understand basics of sterile filtration and requirements for PUPSIT

ISOLATOR HANDS ON ACTIVITIES

• Proper glove usage including glove entry/exit

• Glove leak testing and visual inspection

• Collecting air and surface EM samples inside of an isolator (handling contact plates, settle plates and swabs)

• Aseptic behaviors inside an isolator (proper movements inside an isolator, transferring materials in and out of an isolator)

• Cleaning and disinfection inside an isolator

Marsha Steed

Lead Instructor – Marsha Steed, Founder and CEO Steed MicroBio LLC and Microbiology Expert Consultant Jeff Yuen & Associates Marsha Steed has over 30 years of experience as a microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields. Marsha is the Founder and President of Steed MicroBio, LLC which is an independent microbiology consulting firm and a Senior Microbiology Associate/Sterility Assurance Expert at Jeff Yuen & Associates, Inc. consulting firm. Marsha is a globally recognized consultant specializing in sterility assurance and contamination control matters in pharmaceutical, biotech and medical device companies. Marsha is a USP Microbiology Expert Committee member and the chair of the USP Microbial Control and Sterility Assurance Subcommittee. Marsha studied Biology at Western New England University in Springfield, MA.

Les Edwards

Instructor – Les Edwards, VP Technology and BD at SKAN US Les Edwards is currently VP Technology and Business Development for SKAN US (since 2011), the Swiss-based worldwide leader in pharmaceutical aseptic isolators. Les’ career in aseptic pharmaceutical and biologics manufacturing has been a mix of development, technical and executive roles in which he has been responsible for managing projects and deploying advanced solutions for aseptic manufacturing worldwide. As a subject matter expert in Aseptic Processing, Isolation/Containment Technology and H2O2 bio decontamination, Les has spoken well over 100 times on these topics in global settings since the early 1990s. Les holds a Bachelor of Science in Bioengineering and a Masters in Technology Management, both from the University of Pennsylvania (School of Engineering / Wharton School of Business) in Philadelphia.

Erwin Andrews

Instructor – Erwin Andrews, Senior Consultant & Aseptic Processing Expert, Jeff Yuen & Associates Erwin Andrews has 17 years of experience in the pharmaceutical industry. Those 17 years have consisted of aseptic manufacturing leadership and quality assurance leadership roles. In these roles, Erwin has focused on instilling a quality mindset in his organizations. Prior to joining Jeff Yuen and Associates, Erwin worked with leading commercial and contract pharmaceutical companies (Merck, Novo Nordisk, Catalent, Emergent, and Pharmaceutics International, Inc.). Erwin developed a strategic vision for his teams and worked with them to accomplish the vision. Erwin has a BS degree from North Carolina Agricultural and Technical State University.

Merritt Postma

Instructor – Merritt Postma, Executive Director of North America Sales, SKAN US Merritt Postma is the Executive Director, North American Sales for SKAN US in Raleigh, NC. For the last eight years, he has specialized in decontamination and isolator technology. Since 1997, Merritt has been involved in many aseptic filling, freeze drying, and packaging line projects. He is passionate about using new technology and automation to increase sterility assurance and provide safer products to the patients and greater protection to the operators. He is a past president and current board member of the ISPE LA Chapter.

Zoe Reilly

Instructor – Zoe Reilly, Process Applications, SKAN US Zoe Reilly is the SKAN US Process Applications Specialist, serving as the in-house Subject Matter Expert for Sterility Testing and Advanced Therapy Medicinal Products (ATMPs). With a robust background as the Sterility Testing Technical Lead at a major pharmaceutical company, Zoe has engaged in numerous discussions with major regulatory bodies and supported a significant facility transfer for a sterility testing laboratory. Her extensive experience with barrier isolators and passion for sterility testing led her to SKAN, where she continues to apply her expertise to advance the field.