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:
- Protection (light exposure, oxygen, moisture permeation, leakage)
- Safety (extraction/toxicological evaluation studies)
- 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),
- <382> Elastomeric Component Functional Suitability in Parenteral Products 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!