Advanced Container Closure Integrity Testing (CCIT) Training Course

Advanced Container Closure Integrity Testing (CCIT) Training Course

Introduction

Advanced Container Closure Integrity Testing (CCIT) Training Course a comprehensive program designed to empower professionals in the pharmaceutical and biotech industries. As regulatory bodies like the FDA and EMA increasingly mandate the use of deterministic methods over traditional, probabilistic ones, this course fills a critical knowledge gap. Participants will delve into the latest non-destructive technologies, including High Voltage Leak Detection (HVLD), Headspace Analysis, and Helium Mass Spectrometry, to ensure product sterility and patient safety. Our curriculum emphasizes practical, hands-on training and real-world case studies to bridge the gap between theoretical knowledge and practical application, providing a robust framework for developing and validating CCIT strategies throughout the product lifecycle.

The course is built around the core principle of risk-based quality assurance, aligning with USP <1207> and EU GMP Annex 1. We focus on equipping learners with the skills to select the most appropriate CCIT method for a given container type, defining the Maximum Allowable Leakage Limit (MALL), and implementing 100% in-line inspection solutions. By mastering these advanced techniques, professionals can mitigate risks, improve operational efficiency, and ensure regulatory compliance. Our expert-led instruction combines theoretical lectures with practical exercises, enabling participants to confidently troubleshoot issues, optimize test parameters, and make informed decisions that safeguard product integrity from development to commercialization.

Course Duration

10 days

Course Objectives

1. Master advanced deterministic CCIT technologies and their application.
2. Analyze and interpret complex data from Helium Leak Detection and Mass Extraction.
3. Develop and validate robust CCIT methods in compliance with USP <1207> and EU GMP Annex 1.
4. Implement a risk-based approach to define Maximum Allowable Leakage Limit (MALL).
5. Evaluate and select appropriate CCIT methods for various container-closure systems.
6. Troubleshoot common container integrity issues and system errors.
7. Integrate CCIT into the product lifecycle from R&D to manufacturing.
8. Understand the principles of Headspace Analysis for stability studies.
9. Apply High Voltage Leak Detection (HVLD) for liquid-filled products.
10. Optimize Vacuum Decay and Pressure Decay testing parameters.
11. Perform equipment qualification and method validation for CCIT systems.
12. Ensure ongoing quality control and process monitoring with CCIT.
13. Comply with the latest pharmaceutical regulations and guidelines.

Organizational Benefits

• Minimizes the risk of costly regulatory citations, recalls, and product rejections by ensuring adherence to evolving standards like USP <1207> and Annex 1.
• Proactively identifies and mitigates container closure defects, protecting the integrity of sterile products and safeguarding patient health.
• Reduces testing time and costs through the use of faster, more accurate non-destructive methods, enabling 100% in-line inspection.
• Adopting non-destructive testing eliminates the need to discard samples, saving valuable time, product, and resources.
• Demonstrates a commitment to quality and safety, strengthening consumer and regulatory confidence in your brand.

Target Audience

1. Pharmaceutical Scientists & Engineers.
2. Quality Assurance (QA) & Quality Control (QC) Managers.
3. Manufacturing & Production Staff.
4. Regulatory Affairs Professionals.
5. R&D Scientists.
6. Sterility Assurance Specialists.
7. Biologics & Medical Device Professionals.
8. Technical Support & Service Engineers.

Course Modules

Module 1: CCIT Fundamentals & Regulatory Landscape

• Introduction to container-closure integrity and its importance.
• Overview of USP <1207>, EU GMP Annex 1, and other global guidelines.
• Defining the Maximum Allowable Leakage Limit (MALL).
• Distinguishing between probabilistic and deterministic test methods.
• Case Study: Analyzing a recent regulatory warning letter related to CCIT failure.

Module 2: High Voltage Leak Detection (HVLD)

• Working principles of HVLD for liquid-filled vials and syringes.
• Calibration and method development for different product types.
• Practical session on operating an HVLD instrument.
• Troubleshooting common issues like product conductivity and bubbles.
• Case Study: Optimizing HVLD for a low-conductivity biological product.

Module 3: Headspace Analysis (HSA)

• Principles of laser-based headspace analysis (TDLAS).
• Measuring headspace oxygen and moisture for stability monitoring.
• Setting up the system for lyophilized products and vaccines.
• Detecting temporary leaks and verifying vacuum retention.
• Case Study: Using HSA to monitor the shelf-life stability of a freeze-dried drug.

Module 4: Helium Mass Spectrometry (HMS)

• Principles of Helium Leak Detection (HMS) for ultra-sensitive applications.
• Understanding the difference between vacuum mode and sniffer mode.
• Setting up the system and preparing samples for testing.
• Interpreting mass spectrometer data and calculating leak rates.
• Case Study: Validating a new container-closure system using highly sensitive HMS.

Module 5: Mass Extraction Technology

• Principles of Mass Extraction and its benefits.
• Detecting leaks in porous and non-porous containers.
• Practical session on using a mass extraction leak tester.
• Understanding the technology's application for 100% in-line inspection.
• Case Study: Implementing a mass extraction system on a high-speed production line.

Module 6: Vacuum Decay & Pressure Decay Methods

• Working principles of vacuum decay and pressure decay testing.
• Applications for flexible and rigid container types.
• Practical session on setting test parameters and interpreting results.
• Advantages and limitations of these technologies.
• Case Study: Troubleshooting a vacuum decay test for a blister pack.

Module 7: Method Development & Validation

• Developing a method validation protocol for a new CCIT method.
• Establishing detection sensitivity and robustness.
• Defining positive controls and challenge leaks.
• Performing method validation studies and writing the report.
• Case Study: Developing a new CCIT method for a pre-filled syringe.

Module 8: CCIT in the Product Lifecycle

• CCIT requirements during early-stage development.
• Implementing CCIT during process validation (PV).
• Routine in-line and at-line testing in commercial manufacturing.
• Integrating CCIT into ongoing stability studies.
• Case Study: A full product lifecycle CCIT strategy from R&D to market.

Module 9: Risk Management & Quality by Design (QbD)

• Applying risk-based approaches to CCIT.
• Conducting a Failure Mode and Effects Analysis (FMEA) for container integrity.
• Using Quality by Design (QbD) principles to build a robust CCIT strategy.
• Defining Critical Quality Attributes (CQAs) related to CCIT.
• Case Study: Using QbD to identify and control risks in a new vial-stopper system.

Module 10: Process Analytical Technology (PAT)

• Introduction to PAT and its role in modern manufacturing.
• Using CCIT as a PAT tool for real-time process monitoring.
• Integrating CCIT systems into automated lines.
• Data analysis and statistical process control (SPC) for CCIT data.
• Case Study: Implementing an in-line Headspace Analysis system for real-time process control.

Module 11: CCIT for Special Container Types

• Specific challenges and methods for ampoules and cartridges.
• CCIT for medical devices and combination products.
• Testing integrity of Blow-Fill-Seal (BFS) containers.
• Strategies for testing IV bags and flexible pouches.
• Case Study: Selecting the correct CCIT method for a new BFS vaccine product.

Module 12: Data Integrity & Audit Readiness

• Ensuring data integrity for all CCIT results.
• Meeting 21 CFR Part 11 requirements for electronic records.
• Preparing for a regulatory inspection and audits on CCIT.
• Best practices for record keeping and documentation.
• Case Study: Responding to an FDA audit finding on CCIT data integrity.

Module 13: Advanced Troubleshooting & Optimization

• Advanced techniques for diagnosing system malfunctions.
• Optimizing test parameters for improved sensitivity and speed.
• Analyzing complex leak signatures and differentiating them from noise.
• Understanding the physical limitations of each CCIT method.
• Case Study: Troubleshooting a false positive rate issue on a helium leak detector.

Module 14: Emerging Technologies in CCIT

• Introduction to AI and Machine Learning in CCIT.
• Advanced spectroscopic techniques and their applications.
• Future trends in non-destructive testing for pharma.
• Analyzing new technologies for ultra-sensitive leak detection.
• Case Study: A predictive maintenance model for a CCIT system using AI.

Module 15: Capstone Project & Certification

• Participants apply their knowledge to a comprehensive final project.
• Developing a complete CCIT strategy for a mock product.
• Presenting a method validation report and QbD plan.
• Q&A session with industry experts.
• Final certification exam to validate competency.

Training Methodology

This course employs a participatory and hands-on approach to ensure practical learning, including:

• Interactive lectures and presentations.
• Group discussions and brainstorming sessions.
• Hands-on exercises using real-world datasets.
• Role-playing and scenario-based simulations.
• Analysis of case studies to bridge theory and practice.
• Peer-to-peer learning and networking.
• Expert-led Q&A sessions.
• Continuous feedback and personalized guidance.

Register as a group from 3 participants for a Discount

Send us an email: [email protected] or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.