Plastic/Elastomeric Materials for Pharmaceutical Packaging and Production
25/26 September 2019, Barcelona, Spain
Course No. 16440
Speakers
Torsten Kneuss
Bayer
Dr Bettine Boltres
West Pharmaceutical Services
Objectives
This conference deals with the development, manufacture, use and control of plastic/ elastomeric materials for medicinal products, medical devices & combination products and for use in manufacturing. The conference gives you an update on the U.S., E.U. and Chinese regulatory requirements and shows you how these requirements can be put into practice. One of the focus topics is the use of additives as well as their testing and assessment by means of extractables/leachables studies. You also get the latest information on child-resistant packaging. And the conference subjects are rounded off from a GMP compliance point of view with the topics testing of plastic/elastomeric materials and handling of plastic/elastomeric materials during manufacturing.
Background
European Requirements on the development, testing and registration of plastic materials can among others be found in the EMA „Guideline on Plastic Immediate Packaging Materials”. U.S. requirements are laid down in the FDA Guidance for Industry „Container Closure Systems for Packaging Human Drugs and Biologics“. In Addition, since reforms of the existing Chinese regulations started as from mid 2016 on, it has become a really hot topic for pharma industry.
The EMA guideline covers the specific requirements (data to be submitted) for plastic packaging materials intended to be in direct contact with the medicinal product or the API. The guideline has to be applied in new registration applications or in variation applications. However, the guideline does not cover requirements for elastomeric components. In Addition, the EU regulation 10/2011 on plastic materials and articles intended to come into contact with food also deals with plastic materials but not with elastomeric materials.
According to the FDA guideline, each application should contain enough information to show that each proposed container closure system and its components are suitable for its intended use. This includes:
Performance (container closure system functionality, drug delivery)
Today, new requirements are coming up, since there are currently many medical devices and combination products (e.g. pre-filled syringes) on the market. These devices sometimes contain materials currently not monographed by the pharmacopoeias (for example COC and COP). And: Are there any requirement for plastic materials (e.g. tubes) used in the manufacture of pharmaceutical drug products and biopharmaceuticals? This conference presents updates on the regulatory requirements on these materials. There are currently a lot of pharmacopoeial changes/developments going on, e.g. recent drafts for USP General Chapters:
<381> Elastomeric Closures for Injections (proposed new title: ELASTOMERIC COMPONENTS IN INJECTABLE PHARMACEUTICAL PRODUCT PACKAGING/DELIVERY SYSTEMS),
<1381> Assessment of Elastomeric Components Used in Injectable Pharmaceutical Product Packaging/Delivery Systems,
<1382> Assessment of Elastomeric Component Functional Suitability in Parenteral Products Packaging /Delivery Systems.
These 4 chapters were published in Pharmacopeial Forum (PF) 43(3) [May–Jun. 2017]. Revised drafts have recently been pre-published on the USP website. According to the USP, the proposed revisions will be published in Pharmacopeial Forum (PF) 45(4) [Jul.–Aug. 2019]. The objective of this pre-posting is to give stakeholders sufficient time to review the proposals and comment by September 30, 2019. In the absence of any adverse comments the chapters are anticipated to be published in USP 43-NF 38, Second Supplement (the targeted official date is December 1, 2020).
In a recent issue of Pharmacopeial Forum (PF 45(2) [March–April 2019]) the following general chapter have been re-published for comment
<661> Plastic Packaging Systems and Their Materials of Construction,
<661.1> Plastic Materials Of Construction,
<661.2> Plastic Packaging Systems for Pharmaceutical Use,
<1661> Evaluation of Plastic Packaging Systems and Their Materials of Construction With Respect to Their User Safety Impact,
<665> Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products,
<1665> Characterization of Plastic Materials, Components, and Systems Used in the Manufacturing of Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products.
According to the new draft for <661.1> “it is being left up to the material user to evaluate the need for extractable elements testing and, if such testing is necessary, to establish and justify the means by which testing is accomplished”.
Furthermore Ph. Eur. Draft Chapters on “new” plastic/ elastomeric materials like, for example, COC/ COP (Cyclo-olefin Polymer) and SBC are expected to be published soon:
3.1.17 Cyclo-olefin copolymers (COC),
3.1.18 Styrene block copolymers (SBC) for containers and closures for parenteral and ophthalmic preparations.
This conference provides an excellent forum to discuss open questions regarding the ongoing developments directly with speakers from industry, regulators and members of the pharmacopoeial expert working groups!
Target Group
The conference 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 and/or manufacturers of plastic/elastomeric (packaging) materials for the pharmaceutical industry.
Free PDF-Download - exclusive for Participants
Defect Evaluation List for Rubber Parts, New Edition 2019!
Checklists and instructions for use in the testing of packaging material
Programme
Introduction into Plastic and Elastomeric Materials and Manufacturing of Elastomeric Materials
Scientific Background of plastics and elastomers
Relevant physical properties and their impact on product quality
Overview of manufacturing process for elastomers
U.S. Regulatory Requirements for Plastic/ Elastomeric Materials
General regulatory requirements
FDA Guidance on Container Closure Systems
Update of Compendial Standards: relevant USP General Chapter
E.U. Regulatory Requirements for Plastic/ Elastomeric Materials
General regulatory requirements
EMA Guideline on plastic immediate packaging materials
Update of Compendial Standards: relevant Ph. Eur. General Chapter
Chinese Regulatory Requirements for Plastic/ Elastomeric Materials
Update on Chinese regulations started as from mid 2016 on
Specific Requirements for Plastic/ Elastomeric Materials
When is a material of pharmacopoeial quality?
Material selection criteria
Material properties and design
Example: Prefilled plastic syringes made of COC and COP
Polymer Additives in Plastic / Elastomeric Materials
Types of additives
Their mode of action
Use
Function
Physical Behaviour
USP <665>: Polymeric components and systems used in the manufacturing of pharmaceutical and biopharmaceutical drug products
Drivers for Innovative Manufacturing
Risk Assessment for Manufacturing Systems
USP <665>
Our Strategy
Supplier Qualification – A Risk based Approach
Quality agreement
Supplier review
Applicable Standards
Risk-based qualification
Extractables / Leachables (E&Ls)
Regulatory Requirements
When is Extractable testing necessary?
Best Practices for E&L testing
Which components could be potential E&Ls?
Case Study
Manufacturing of Plastic Materials (and Handling in the Warehouse)
Storage
Processing
IPC and Reconciliation
Shopfloor requirements
Blister integrity testing
Quality Control of Plastic/ Elastomeric Materials
Specifications
Sampling plans, AQLs (Acceptable Quality Levels) and DELs (Defect Evaluation Lists)
Common test methods
Challenges
Child-resistant Packaging
Definition
Testing procedures
Child resistance vs. Senior friendliness
Examples
This course is part of the GMP Certification Programme "ECA Certified Packaging Manager" Learn more
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