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

14-15 September 2016

Prague, Czech Republic

Seminar Nr. 15493

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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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