Instructor :
Roger Cowan

Webinar ID:
13557

Ensuring a robust and validated sterile filtration process is critical for pharmaceutical manufacturers to maintain product integrity, patient safety, and regulatory compliance.

However, validation requirements and process parameters vary depending on the specific application, making it essential to have a deep understanding of industry best practices.

This expert-led training provides a comprehensive and practical approach to sterile filtration validation, helping you navigate regulatory expectations and optimize your filtration strategy. You will gain in-depth knowledge of various sterilizing filtration methods and how they apply to different pharmaceutical systems, including use-point compressed air filtration.

Key Takeaways:

• • Types of Sterile Filtration
    • • Understand the differences between various sterilization filtration techniques and their applications.

• • Validation Requirements
    • • Learn how to properly validate sterile filtration processes based on your specific filtration needs.

• • Regulatory Expectations
    • • Stay aligned with FDA, EMA, and industry best practices for compliance and risk mitigation.

• • Application-Specific Insights
    • • Deep dive into use-point compressed air filtration and other critical applications.

• • Process Optimization
    • • Enhance your filtration strategies to improve efficiency and meet regulatory requirements effectively.

This course is designed to provide clear, actionable insights that will help you confidently manage sterile filtration processes while ensuring full compliance with regulatory standards.

Whether you are involved in quality assurance, validation, manufacturing, or regulatory affairs, this training will equip you with the knowledge needed to implement and maintain a validated sterile filtration system effectively.

Enroll Now!

Ensuring a robust and validated sterile filtration process is critical for pharmaceutical manufacturers to maintain product integrity, patient safety, and regulatory compliance.

However, validation requirements and process parameters vary depending on the specific application, making it essential to have a deep understanding of industry best practices.

This expert-led training provides a comprehensive and practical approach to sterile filtration validation, helping you navigate regulatory expectations and optimize your filtration strategy. You will gain in-depth knowledge of various sterilizing filtration methods and how they apply to different pharmaceutical systems, including use-point compressed air filtration.

Key Takeaways:

• • Types of Sterile Filtration
    • • Understand the differences between various sterilization filtration techniques and their applications.

• • Validation Requirements
    • • Learn how to properly validate sterile filtration processes based on your specific filtration needs.

• • Regulatory Expectations
    • • Stay aligned with FDA, EMA, and industry best practices for compliance and risk mitigation.

• • Application-Specific Insights
    • • Deep dive into use-point compressed air filtration and other critical applications.

• • Process Optimization
    • • Enhance your filtration strategies to improve efficiency and meet regulatory requirements effectively.

This course is designed to provide clear, actionable insights that will help you confidently manage sterile filtration processes while ensuring full compliance with regulatory standards.

Whether you are involved in quality assurance, validation, manufacturing, or regulatory affairs, this training will equip you with the knowledge needed to implement and maintain a validated sterile filtration system effectively.

Enroll Now!

Sterile filtration is a critical step in pharmaceutical manufacturing, but ensuring its proper validation and compliance can be complex and challenging.

Failure to meet regulatory expectations can lead to batch failures, contamination risks, regulatory scrutiny, and costly delays.

This training equips you with the knowledge and tools to proactively address these challenges and implement a fully compliant sterile filtration strategy.

What You’ll Gain from This Training:

• • In-Depth Understanding of Filtration Media
    • • Learn about different filtration materials, their properties, and how to choose the right one for your application.

• • Comprehensive System Breakdown 
    • • Explore a detailed pharmaceutical sterile filtration system with engineering schematics and component analysis.

• • Microbiology & Particle Retention Insights
    • • Understand how filters work at a microbial level to effectively remove contaminants while preserving product quality.

• • Integrity Testing & Validation Mastery
    • • Gain expertise in integrity testing methods, filter sterilization techniques (SIP, autoclaving), and media qualification.

• • Regulatory Compliance Clarity
    • • Get a compiled overview of FDA/EU GMP guidelines, including the roles and responsibilities of filter manufacturers and users.

By attending this training, you will develop the expertise needed to ensure robust sterile filtration processes, reduce compliance risks, and safeguard product integrity, making it an essential learning experience for quality assurance, validation, manufacturing, and regulatory professionals.

Register Today!

Sterile filtration is a critical step in pharmaceutical manufacturing, but ensuring its proper validation and compliance can be complex and challenging.

Failure to meet regulatory expectations can lead to batch failures, contamination risks, regulatory scrutiny, and costly delays.

This training equips you with the knowledge and tools to proactively address these challenges and implement a fully compliant sterile filtration strategy.

What You’ll Gain from This Training:

• • In-Depth Understanding of Filtration Media
    • • Learn about different filtration materials, their properties, and how to choose the right one for your application.

• • Comprehensive System Breakdown 
    • • Explore a detailed pharmaceutical sterile filtration system with engineering schematics and component analysis.

• • Microbiology & Particle Retention Insights
    • • Understand how filters work at a microbial level to effectively remove contaminants while preserving product quality.

• • Integrity Testing & Validation Mastery
    • • Gain expertise in integrity testing methods, filter sterilization techniques (SIP, autoclaving), and media qualification.

• • Regulatory Compliance Clarity
    • • Get a compiled overview of FDA/EU GMP guidelines, including the roles and responsibilities of filter manufacturers and users.

By attending this training, you will develop the expertise needed to ensure robust sterile filtration processes, reduce compliance risks, and safeguard product integrity, making it an essential learning experience for quality assurance, validation, manufacturing, and regulatory professionals.

Register Today!

1. Introduction to Sterile Filtration

• • Importance of quality and sterility assurance in pharmaceutical filtration
  • Key risks and challenges in sterile filtration
  • Overview of global regulatory expectations (FDA, EMA, GMP, etc.)

2. Sterile Filtration System Design

• • Critical components of a sterile filtration system
  • Engineering schematics and system architecture
  • Factors affecting filter performance and efficiency

3. Filtration Media & Retention Mechanisms

• • Comparison of different filtration media and their applications
  • Particle and microbial retention mechanisms
  • Impact of pore size, structure, and material compatibility

4. Sterilization Methods for Filters

• • Steam-in-Place (SIP), Autoclaving, and Gamma Irradiation techniques
  • Best practices for maintaining filter integrity post-sterilization
  • Common challenges and troubleshooting in sterilization processes

5. Validation of Sterile Filtration Systems

• • Establishing a robust validation protocol
  • Key validation parameters: time, pressure, temperature
  • Microbial retention challenge testing

6. Integrity Testing of Filters

• • Overview of integrity testing methods and their importance
  • Commonly used techniques: Bubble Point, Forward Flow, and Diffusive Flow Testing
  • When and how to perform integrity tests for regulatory compliance

7. Product Compatibility & Risk Assessments

• • Evaluating compatibility of filters with drug products
  • Identifying and mitigating risks of leachables, fibers, and endotoxins
  • Extractable and leachable testing methodologies

8. Regulatory Requirements & Compliance Guidelines

• • Overview of FDA and EU GMP regulations for sterile filtration
  • Responsibilities of filter manufacturers vs. end-users
  • Ensuring audit readiness and documentation compliance

9. Q&A and Discussion

• • Interactive session addressing real-world challenges faced by participants
  • Practical recommendations and expert insights for troubleshooting and process optimization

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

1. Introduction to Sterile Filtration

• • Importance of quality and sterility assurance in pharmaceutical filtration
  • Key risks and challenges in sterile filtration
  • Overview of global regulatory expectations (FDA, EMA, GMP, etc.)

2. Sterile Filtration System Design

• • Critical components of a sterile filtration system
  • Engineering schematics and system architecture
  • Factors affecting filter performance and efficiency

3. Filtration Media & Retention Mechanisms

• • Comparison of different filtration media and their applications
  • Particle and microbial retention mechanisms
  • Impact of pore size, structure, and material compatibility

4. Sterilization Methods for Filters

• • Steam-in-Place (SIP), Autoclaving, and Gamma Irradiation techniques
  • Best practices for maintaining filter integrity post-sterilization
  • Common challenges and troubleshooting in sterilization processes

5. Validation of Sterile Filtration Systems

• • Establishing a robust validation protocol
  • Key validation parameters: time, pressure, temperature
  • Microbial retention challenge testing

6. Integrity Testing of Filters

• • Overview of integrity testing methods and their importance
  • Commonly used techniques: Bubble Point, Forward Flow, and Diffusive Flow Testing
  • When and how to perform integrity tests for regulatory compliance

7. Product Compatibility & Risk Assessments

• • Evaluating compatibility of filters with drug products
  • Identifying and mitigating risks of leachables, fibers, and endotoxins
  • Extractable and leachable testing methodologies

8. Regulatory Requirements & Compliance Guidelines

• • Overview of FDA and EU GMP regulations for sterile filtration
  • Responsibilities of filter manufacturers vs. end-users
  • Ensuring audit readiness and documentation compliance

9. Q&A and Discussion

• • Interactive session addressing real-world challenges faced by participants
  • Practical recommendations and expert insights for troubleshooting and process optimization

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

Everybody Benefits from Watching This. Even Better When Done as a Group!

• • Quality Assurance and Quality Control Professionals
  • Regulatory Affairs and Compliance Specialists
  • Validation and Process Engineers in Pharma
  • Microbiologists and Sterility Assurance Experts
  • Manufacturing and Production Managers in Biotech
  • R&D Scientists Developing Sterile Drug Products
  • Filter Manufacturers and Technical Support Teams
  • Pharmaceutical Professionals Handling Filtration Systems

Everybody Benefits from Watching This. Even Better When Done as a Group!

• • Quality Assurance and Quality Control Professionals
  • Regulatory Affairs and Compliance Specialists
  • Validation and Process Engineers in Pharma
  • Microbiologists and Sterility Assurance Experts
  • Manufacturing and Production Managers in Biotech
  • R&D Scientists Developing Sterile Drug Products
  • Filter Manufacturers and Technical Support Teams
  • Pharmaceutical Professionals Handling Filtration Systems