Protective Packaging Systems: Basic Principles – Barrier Systems – Performance Testing

Protective Packaging Systems: Basic Principles – Barrier Systems – Performance Testing

Prague, Czech Republic

Seminar Nr. 15493

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Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Torsten Kneuß, Bayer Pharma AG, Germany

Dr Mayk Kresse, Bayer Pharma AG, Germany

Horst Koller, HK Packaging Consulting, Switzerland

Dr Eva Maria Moser, Incoat GmbH, Switzerland

Prof Dr Ursula Probst, Stuttgart Media University, Packaging Technology, Germany

Dr Jörg Zürcher, Bayer Pharma AG, Germany

Objectives

The aim of this conference is to provide up-to-date knowledge about protective packaging solutions for the stability of pharmaceutical and cosmetic products, and foodstuff (Barrier Packaging). Which physical fundamentals are relevant? Which measuring procedures and methods do exist? Which drying agent systems are used? Which options in terms of protective packaging (blisters, bottles, tubes, vials, and syringes) in relation to the dosage form (solids, liquids, semi-solids) and the route of administration (oral, parenteral, and topical) exist, all these questions will be answered and practical case studies will be presented.

Background

Pharmaceutical and cosmetic products and foodstuff have to be packaged in container-closure systems that protect them from factors that can endanger the stability of the product. Moisture permeation/barrier packaging and container closure system integrity is a constant challenge and a regular work stream for expert groups like the Product Quality Research Institute (PQRI) or the Parenteral Drug Association (PDA).

Moisture permeation is a common challenge that can impact the quality of the product, so having a more accurate and reproducible method to determine how effective the packaging is at keeping moisture out will be a benefit to industry. Accordingly, USP recently revised the packaging and moisture permeation chapters (USP General Chapter <671> Containers—Performance Testing) to include a new method for determining moisture permeation for high and low barrier pharmaceutical packaging. USP is also considering changing the USP classification system for packaging, which is limited so far to “well-closed”, “tight”, and “hermetic” containers.

Today, the appropriate packaging system is commonly chosen on a „trial & error” approach (orientating stability investigations under stress conditions). However, this “procedure” shows its limits when no appropriate packaging has been identified within this „trial & error” approach. Hence, only precise knowledge of the physical processes of permeation in conjunction with the material features of the packaging and the protection requirements of the dosage form will finally provide a scientific rational for the selection of the best packaging system with optimal product protection.

Moreover, the scientific understanding of the most important parameters helps to identify critical quality attributes and to define a “design space” which is in line with increasing demands of Quality by Design (QbD).

Target Group

This course is especially designed for members of staff and executives from the pharmaceutical industry working in the field of research and development, regulatory affairs, quality control, incoming goods control of packaging materials, quality assurance, production and packaging. It is also directed at employees of suppliers manufacturing packaging materials for the pharmaceutical or cosmetic and foodstuff industry.

Programme

Introduction: The Importance of Protective Packaging

  • Factors, which endanger the stability of pharmaceuticals
  • Introduction to stability and stability testing
  • Climate parameters (Mean kinetic temperature)
  • Climate zone concepts (ICH, ASEAN)
  • Options to improve stability
Important Fundamentals: Relevant Physical Aspects of Migration and Permeation
  • Definition of terms
  • Migration models
  • Permeation models
  • Practical applications in packaging technology
Measuring Systems and Methods
  • Different types of methodologies
  • Common measuring systems for leakage and permeability testing
  • Standard for measuring systems and methods (e.g. ISO, ASTM)
Blisters
  • Polymers for thermoformed blisters: COC, PCTFE, PP, PVC, PVdC, etc.
  • Critical parameters for barrier systems
  • Barrier of flat film and the formed film
  • Simulation of permeation through mono- and multilayer structures
„Tight” and “hermetic” Containers
  • Flexible Packaging Systems
  • Systems overview: Coldform blisters, bags, sachets, etc.
  • Definitions
  • Pinholes and cross diffusion
  • Simulation of moisture permeation across pinholes and sealing area
Bottle Systems for Oral Products
  • Plastic and glass systems
  • Closure construction and induction seals
  • Moisture barrier and leakage tightness
  • Transfer of barrier properties from blisters to bottles and vice versa
Packaging Systems (Tubes) for Topical Products
  • Highly efficient and sustainable diffusion barrier layer
  • Corrosion protection for metallic supports
  • Complete emptying of content
  • Protecting content from undesired interactions by packaging
  • Protecting content from external contamination
Permeation in Parenteral Dosage Forms: Vials and Syringes
  • Methods for measurements of barrier properties
  • Barrier coatings
  • Barrier improvement factor (BIF)
  • QbD: Burden or benefit
  • Case study: Polymer vs. glass
Desiccants and Drying Systems
  • Desiccant types and packaging systems
  • Desiccant selectivity
  • Adsorption capacity and adsorption rate
  • Residual moisture
  • Modified atmosphere packaging (MAP)
Case Study: Calculation/Simulation
  • How to compare own measurements with literature data: Pitfalls related to unit conversion
  • Prediction of barrier for numerous T/RH conditions
  • How to use the Arrhenius expression for shelf-life prediction
Container Closure Integrity Testing
  • Physical test methods
  • Microbiological test methods
  • USP 1207
  • Method comparison and recommendations
Tightness during Shipment
  • Why to test
  • What to test
  • How to test
  • Practical experience from development projects
Migration through Containers
  • Migration process
  • Test methods for migration testing
  • Case study - study design
  • Conclusions from the case study
Container/ Drug Interactions
  • Examples of recent observations and recalls
  • Possible root causes
  • Alternative packaging systems

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