TwoKnct Media & Publishing

Aseptic Processing Technology Conference

REGISTRATION:

HIGHLIGHTS

  • Advancements in Aseptic Techniques: Highlighting the latest developments in barrier systems, sterilization, and filling for product safety.
  • Regulatory Compliance and Quality Assurance: Addressing updates and best practices for maintaining high standards in aseptic manufacturing.
  • Digitalization and Automation: Exploring the role of digitalization and automation in optimizing processes and reducing errors.
  • Sustainability and Innovation: Discussing sustainable practices, waste reduction, and innovative solutions in aseptic processing.
  • Risk Management and Contamination Control: Sharing insights on risk assessment and proactive contamination control strategies.
  • Future Trends: Examining emerging technologies like single-use systems, robotics, and advanced sterilization methods shaping aseptic processing
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VENUE: HOTEL MELIÁ VALENCIA, SPAIN

Welcome to the Aseptic Processing Technology Valencia Conference The Aseptic Processing Technology Conference is a premier gathering that brings together industry experts, researchers, regulators, and stakeholders involved in aseptic processing across various sectors such as pharmaceuticals, biotechnology, food and beverage, and cosmetics. The conference serves as a a platform for sharing insights, discussing advancements, and addressing challenges in aseptic processing technology.

ABOUT THE CONFERENCE

Participants can expect engaging sessions such as keynote addresses, panel discussions, case studies, and networking opportunities to foster collaboration, knowledge sharing, and professional connections within the aseptic processing community. The conference aims to inspire innovation, promote best practices, and drive continuous improvement in aseptic manufacturing processes across industries. The Aseptic Processing Technology Conference is designed for professionals, experts, and stakeholders from various industries involved in aseptic processing and manufacturing. Attendees from the following sectors would find this conference highly beneficial.

How to Book?

Please send your registration form to:
registration@twoknct.com

AUDIENCE DIRECTORS, VPS, MANAGERS AND HEADS OF:

  • Cutting-Edge Aseptic Processing Techniques: Providing insights for directors, VPs, managers, and heads of departments on the latest advancements in aseptic
    processing technology.
  • Regulatory Compliance and Quality Assurance: Addressing compliance challenges and quality assurance standards specific to aseptic processing for senior leadership in pharmaceutical manufacturing.
  • Digitalization and Automation in Aseptic Processing: Exploring the role of digitalization and automation for optimizing processes and reducing errors in aseptic manufacturing.
  • Sustainability and Innovation in Aseptic Processing: Discussing sustainable practices, waste reduction, and innovative solutions for senior leadership in charge of aseptic processing.
  • Future Trends and Disruptive Technologies: Examining emerging trends and disruptive technologies shaping the future of aseptic processing for top-level decisionmakers in pharmaceutical manufacturing.

INDUSTRIES

  • Pharmaceutical Industry: Gain insights into aseptic processing, regulatory compliance, and quality control tailored for pharmaceutical professionals in manufacturing, R&D, and quality assurance.
  • Biotechnology and Biopharmaceuticals: Explore advanced aseptic technologies and contamination control strategies for bioprocessing and biomanufacturing applications.
  • Food and Beverage Industry: Learn about aseptic packaging advancements and sustainable practices for producing packaged products like juices, dairy, and sauces.
  • Cosmetics and Personal Care: Discover aseptic filling and packaging technologies specific to cosmetics and personal care products, ensuring quality assurance.
  • Medical Device Manufacturing: Understand sterilization techniques and risk management strategies crucial for maintaining sterility in medical device production.
  • Regulatory and Compliance Professionals: Stay updated on regulatory requirements and validation standards essential for ensuring aseptic processing compliance
    across industries.
  • Academic and Research Institutions: Gain insights into cutting-edge research and technologies shaping the future of aseptic manufacturing, benefiting researchers,
    academics, and students alike

KEYNOTE SPEAKERS

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Seema Bhatlekar

Scientist, Gene Therapy Process Development, Janssen Pharmaceuticals

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Jim Polarine Jr

Senior Technical Service Manager STERIS Corporation | Life Sciences Marketing

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Chimere Curry

STERILE PROCESSING EXPERT PUBLIC SPEAKER EDUCATOR CONSULTANT

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Elizabeth Casey

CNOR CRCST CHL SVP of Clinical Operations

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Chris Berridge

GLOBAL TECHNICAL CONSULTANT, BIO-DECONTAMINATION SPECIALIST

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Stefan Schneid

Scientific Lead Parenterals and Bayer Science Fellow

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Garrett Hollembeak

Infection Preventionist – Fairfield

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Latoya Chapman

EDUCATOR | SPEAKER | CONSULTANT | SUBJECT MATTER EXPERT

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Christa Myers

Sr. Fellow - Aseptic & Sterile Products

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Alberto González

Global Microbiology / Aseptic Related BPO

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Morgan Polen

Cleanroom Contamination Control Expert

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Kyree U. Thomas

OPERATIONS MANAGER| EDUCATOR| SUBJECT MATTER EXPERT| PUBLIC SPEAKER| HEALTHCARE STERILE PROCESSING ASSOCIATION (HSPA) CERTIFICATION COUNCIL MEMBER| HSPA GOLDEN CROWN CERTIFICATION

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Morgan Polen

Cleanroom Contamination Control Expert

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Matthias Angelmaier

Senior Project Engineer Fill-Finish Global Technology Partner - SME Fill-Finish and Isolator Technology

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Ohad Karnieli

Founder and CEO at ADVA Biotechnology

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Latoya Chapman

EDUCATOR | SPEAKER | CONSULTANT | SUBJECT MATTER EXPERT

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SPONSOR

AGENDA , DAY ONE

REGISTRATION AND WELCOME COFFEE
OPENING ADDRESS FROM THE CHAIRMAN
IMPROVING THE EFFICIENCY OF RECOVERY DURING DOWNSTREAM PROCESS DEVELOPMENT
  • Optimize purification steps to reduce time and increase yield.
  • Use high-throughput screening for rapid evaluation of conditions.
  • Implement continuous processing for better productivity.
  • Apply Quality by Design (QbD) to control variability.
  • Adopt single-use systems to reduce contamination and downtime
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Seema Bhatlekar
Scientist, Gene
Therapy Process
Development, Janssen
Pharmaceuticals

DEVELOPING A CONTAMINATION CONTROL STRATEGY (CCS): FOCUSED ON PERSONNEL PRACTICES AND CLEANING AND DISINFECTION
  • Focus on Operator Behavior
  • Emphasis on a Robust CCS program with Continuous Improvement
  • Cleaning and Disinfectio
  • Rotation and Rinsing
  • Material Transfer
  • CCS Lifecycle
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Jim Polarine Jr
Senior Technical Service Manager STERIS Corporation | Life Sciences Marketing

MORNING COFFEE AND BREAK SPEED NETWORKING

Innovative approach to maximize networking capabilities through two minute periods, where delegates can meet their peers and exchange business cards before rotating to the next company representative

USING RISK MANAGEMENT TO DESIGN ASEPTIC PROCESS SIMULATIONS
  • Annex 1 states that “QRM (Quality Risk Management) applies to this document in its entirety”.
  • Does this mean we can use QRM to justify non-compliance with Annex 1 requirements? The answer here is clear: No.
  • So when can we use QRM? And for what purpose?
  • In this presentation we will go through several practical examples for using QRM to design Aseptic Process Simulations (media fills): when using QRM is not allowed, when it is permitted and when it is enforced.
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Alberto González
GLOBAL STERILITY ASSURANCE
ASSOCIATE DIRECTOR

NETWORKING COFFEEBREAK PANEL DISCUSSION
POINTS TO CONSIDER FOR APS OF LYOPHILIZERS
  • Best Practices
  • Things to avoid
  • Recommendations for Leak Rate Testing
  • Introduction to new robotic filling line
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Stefan Schneid
Scientific Lead
Parenterals and
Bayer Science
Fellow

BUSINESS LUNCH
IMPLEMENTING H2O2 VAPOUR BIODECONTAMINATION TO IMPROVE SUSTAINABILITY
  • Controlling microbial contamination in cleanrooms has historically been performed by a manual approach, either by wiping or mopping surfaces with biocides that include chemicals that leave residues, which can be carried into and impact the environment
  • Industry is moving towards innovative technologies such as automated hydrogen peroxide vapour bio-decontamination systems which can be either mobile or fully integrated into the fabric of a
    building.
  • H2O2 vapour provides a more efficacious disinfection than manually applied biocides and offers a validated approach ensuring every surface receives the same level of disinfection on every treatment.
  • From a sustainability perspective, H2O2 vapour also eliminates chemical residues, reduces CO2 emissions (less product to be shipped), reduces plastic consumption (fewer bottles of biocide
    required), and reduces water consumption (no rinsing required after disinfection).
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Chris Berridge
GLOBAL TECHNICAL
CONSULTANT,
BIODECONTAMINATION
SPECIALIST

RISE OF THE ROBOTS IN ASEPTIC FILL-FINISH
  • Introduction to Robotic Applications in Pharma
  • What are current trends and challenges for robots in aseptic fillfinish
  • How did the solutions evolve over the years
  • What are ongoing developments and future trends
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Garrett Hollembeak
Infection
Preventionist –
Fairfield

NETWORKING COFFEE BREAK
PANEL DISCUSSION
CHAIRMAN’S CLOSING REMARKS AND END OF DAY ONE
COCKTAIL RECEPTION

AGENDA , DAY TWO

REGISTRATION AND WELCOME COFFEE
OPENING ADDRESS FROM THE CHAIRMAN
RISE OF THE ROBOTS IN ASEPTIC FILL-FINISH
  • Introduction to Robotic Applications in Pharma
  • What are current trends and challenges for robots in aseptic fill-finish
  • How did the solutions evolve over the years
  • What are ongoing developments and future trends
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Matthias Angelmaier
Senior Project Engineer FillFinish
Global Technology Partner –
SME Fill-Finish and Isolator
Technology

ANNEX 1 AND CHANGES THE DIRECTION FORWARD
  • What it says
  • How Annex 1 Changes Transfers
  • How Annex 1 Changes Equipment Design
  • How Annex 1 Changes Facility Design
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Christa Myers
Sr. Fellow – Aseptic &
Sterile Products

MORNING COFFEE AND NETWORKING BREAK
SUSTAINABILITY IN ASEPTIC PROCESSING
  • Green Packaging: Adoption of eco-friendly packaging materials reduces environmental impact.
  • Energy Efficiency: Implementation of energy-saving technologies and practices lowers resource consumption.
  • Waste Reduction: Strategies to minimize waste generation and promote recycling contribute to sustainability goals.
  • Water Conservation: Efforts to reduce water usage and implement water recycling systems conserve this vital resource.
  • Carbon Footprint Reduction: Initiatives to decrease emissions and promote eco-friendly transportation options align with sustainability objectives.
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Ohad Karnieli
Founder and CEO at ADVA
Biotechnology

TAKING A “BULLISH” OUTLOOK ON AI IN STERILE PROCESSING
  • Discuss the Positive and Optimistic Outlook of using AI technology in the Sterile Processing Department
  • Identify The Expectation of Future Growth of Artificial Intelligence within Sterile Processing
    Review Risk of AI Technology
  • Understand the Balance of AI and Human Component
  • Develop a Plan for the future of AI and Human partnership in Sterile
    Processing.
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Elizabeth Casey
CNOR CRCST CHL
SVP OF CLINICAL
OPERATIONS

BUSINESS LUNCH

Workshop

AIRFLOW VISUALIZATION TECHNIQUES AND TECHNOLOGY: HOW TO AVOID COMMON MISTAKES AND MISUNDERSTANDINGS RELATED TO SMOKE STUDIES
  • What is Airflow Visualization?
  • Standards, Regulations, and Guidance on AVS.
  • Technology for AVS.
  • Common Errors with case histories.
  • Conducting an AVS.
  • Planning – Protocol Execution- Review – Storage of AVS data.
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Morgan Polen
Cleanroom
Contamination Control
Expert

NETWORKING COFFEEBREAK
The “WOW” FACTOR: YOUR GUIDE TO PROCESS IMPROVEMENT
  • Review of industry guidelines
  • Discuss implementing a process improvement initiative within a sterile processing area
  • Review of the tools necessary to implement process improvement
  • Review real-time case studies on utilizing process improvement tools
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Chimere Curry
STERILE PROCESSING EXPERT PUBLIC SPEAKER EDUCATOR CONSULTANT

LATOYA CHAPMAN
EDUCATOR | SPEAKER |
CONSULTANT | SUBJECT MATTER
EXPERT

Kyree U. Thomas
OPERATIONS MANAGER| EDUCATOR|
SUBJECT MATTER EXPERT| PUBLIC
SPEAKER| HEALTHCARE STERILE
PROCESSING ASSOCIATION (HSPA)
CERTIFICATION COUNCIL MEMBER| HSPA
GOLDEN CROWN CERTIFICATION

CHAIRMAN’S CLOSING REMARKS AND END OF CONFERENCE

REGISTRATION FORM

DELEGATE PACKAGES:

For academics and nonprofit organization.
Includes the delegate package benefits

For small companies and startups.
Includes the delegate package benefits.

2 days of conference + discussion with industry experts.
Business lunches and cocktail reception

2 days of conference + discussion with industry experts.
2 nights luxury accommodation + transportation service from
airport to hotel. Businesslunches and cocktail reception

SPONSORSHIP PACKAGE

Our sponsorship packages are designed to offer optimum exposure for the budget that are available. For more information on the packages and to discuss your sponsorship requirements, please contact jakub.taborsky@twoknct.net

If you have any specific requirements that you feel are not covered by the packages available, then please do not hesitate to get in touch. We are always available to help you identify the options that suit your budget while maximizing your value and visibility at the conference.

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