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Learning Lab

Innovations in Glass Packaging to Increase Drug Product Quality: The Root Cause of Conventional Container Glass Issues
10:10 - 10:40 Stand L30
Learning Lab
Applications Engineering Manager
Corning Pharmaceutical Technologies, Corning, Inc.

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• Lyophilization processes can be limited by lengthy cycle times and low yields due to glass vial breakage issues.
• The economic implications of vial breakage are significant due to direct loss of product, indirect loss of product due to potential particulate contamination, lengthy clean-up procedures, etc.
• New glass packaging technology is available that reduces damage and breakage to vials and may reduce cycle times.
• Performance data on this enhanced vial will be provided and compared to conventional vial options.

A number of challenges face the manufacturers of freeze-dried products. Glass vial failures, specifically breakage, lensing, and cracks, are a source of product loss and process cost in the freeze-thaw, cryogenic preservation, and lyophilization of pharmaceutical products. Lyophilization is a common method for the preparation of freeze-dried pharmaceutical products, which requires low temperature processing to avoid product damage or decomposition. Because process times are long and lyophilization is regarded as an expensive process, considerable research has focused on improving lyophilization rates to reduce costs. One contributing factor to cost is the failure of glass vials during the lyophilization cycle, which includes freezing, annealing, and drying process steps. This vial breakage results in higher process costs, delays due to destruction of product, and lead to possible drug shortages. New glass vial options specifically designed to meet the needs of the pharmaceutical industry, dramatically reduces breakage and enables lower cost lyophilization compared to conventional glass vials.

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Holistic design approach for an hybrid auto- and bolus-injector platform
10:50 - 11:20 Stand L30
Learning Lab
Head of Strategic Product Management
Haselmeier

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Flexible medical device platforms are getting more and more important serving the needs of different kinds of drugs in various indications. Putting the patient in the center of all considerations in combination with intensive market analysis contributes to a solid product definition and medical device system architecture for numerous treatments. Insights of the patient journey in several indications are fundamental for the development of a strong medical device platform which suits the patients’ needs and creates market acceptance. Based on the holistic design approach a hybrid auto- and bolus injector core technology for subcutaneous self- injection has been designed which reflects the idea of a modular tech-platform paired with convenient usage for various therapies.

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Design with the End in Mind: Patient-centric Innovations in Containment and Delivery of Parenteral Drug Products
11:30 - 12:00 Stand L30
Learning Lab
Director Global Product Management (Polymer Prefilled Systems and Vial Containment),
West Pharmaceutical Services

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• Review of real life case studies of innovations designed with the end in mind.
• A focus on user needs and unique demands drives valuable innovation in the development of novel technologies for primary packaging and delivery of medicines.
• Underpinned by Quality by Design, a new state-of-the-art elastomer platform being introduced.
• Challenges with Biotech products for stability and functional performance. Prefillable syringe innovations, for intravitreal injections and for larger volume autoinjector applications, are now available to help improve usability and drive patient benefit in this rapidly expanding field.

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Packaging and Product Testing Services
12:10 - 12:40 Stand L30
Learning Lab
Technical Advisor - Packaging
STERIS AST

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This presentation will demonstrate the importance of packaging with particular emphasis on sterile barrier packaging, and across numerous packaging levels and functions with particular emphasis on the following:
• ISO 11607 test requirements for complete sterile medical device packages including
• Transportation / distribution testing
• Integrity testing
• Strength testing
• Product testing overview

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Digitisation of the Packaging Supply Chain
12:50 - 13:20 Stand L30
Learning Lab
President and Managing Partner
Faller Packaging GmbH & Co. KG

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• End-to-End digital production of folding cartons with small orders and short lead times
• Managing the supply chain process between customers and suppliers digitally
• New applications for smart packaging

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Best Plastic Vial & Syringe for Oxygen Sensitive Drugs
13:50 - 14:20 Stand L30
Learning Lab
Research Manager
Mitsubishi Gas Chemical Company, Inc.

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• Multilayer Plastic Vial & Syringe
• Excellent oxygen & UV barrier
• Container Closure Integrity
• Storage at Cryogenic Temperature

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Protecting Health vs. Sustainable Packaging - Dream or reality?
14:30 - 15:00 Stand L30
Learning Lab
Director Research & Development
Sanner GmbH

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• How could sustainability in practice affect the healthcare packaging industry?
• How does the European Environmental Policy impact healthcare packaging?
• How could bioplastics contribute to meet the challenges in sustainable healthcare packaging?
• How could a holistic sustainability approach to healthcare packaging look?

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Pharmaceutical labelling for prefilled syringes - providing more than just information
15:10 - 15:40 Stand L30
Learning Lab
Manager Innovation and Strategic Partnerships Healthcare
Schreiner MediPharm
Global Product Manager, Polymer Platform
Schott

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Prefilled syringes (PFS) are continuously gaining market share as they offer a convenient way to administer drugs. Especially PFS made of high-quality polymer, such as Cyclic Olefin Co-polymer (COC), have become a well-established alternative as they offer greater design flexibility while reducing the breakage rate throughout the value chain. Due to its properties and manufacturing process, COC is heavy metal and tungsten free and also features low or no siliconization. This makes it an attractive choice for a number of different applications. Yet, polymer also has a different extractables & leachables (E&L) profile and a lower oxygen and gas barrier threshold than borosilicate glass, increasing the potential for drug interaction. These barrier properties are of concern when it comes to labeling. Labels are an approved and established way to provide the demanded information about the pharmaceutical product directly on the primary packaging. However, as the labels are glued directly onto the container, there is a potential risk of glue migration into the polymer. This can be overcome by using functional labels, which even have the potential to enhance the primary packaging by adding specific material properties – reaching from overt or covert as well as analog and digital security features to providing a strong first opening indication through UV-protection or improved gas barrier properties.

In our speech you will learn more about the following topics that were evaluated:
• Combining a low migration label with COC syringes
• Adding oxygen barrier to COC syringes
• Adding UV-protection to COC syringes
• Adding a first opening indication to COC syringes

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Control your risks, consider Terminal Sterilization first
15:50 - 16:20 Stand L30
Learning Lab
Technical Director EO Pharma
STERIGENICS

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A lack of sterility assurance continues to be a significant reason for product recalls and regulatory citations and can pose a very real risk to patient safety and public health. Sterilisation is therefore a pivotal step in the product development process to help ensure overall safety is maintained. In this presentation we will:

  • Examine the goal and science of sterilization
  • Introduce and contrast Terminal Sterilization and Aseptic Processing through a risk assessment lens
  • Provide guidance for the assessment and selection of the optimal Terminal Sterilisation technology (eg Gamma, E-Beam, ETO)