Horst Koller
HK Packaging
Referierende
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Zielgruppe
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. Employees of suppliers and/or manufacturers of plastic packaging materials for the pharmaceutical industry.
Zielsetzung
The quality of plastic materials has an impact on the quality of plastic containers for pharmaceutical use and thus on the medicinal product. Of particular relevance are the widely used plastic materials COP (cycloolefin polymer) and COC (cyclo-olefin copolymer). In the recent issue of Pharmeuropa drafts for three new Ph. Eur. chapters on plastic materials have been published for comment (public deadline: 30 June 2020):
- 3.1.16. Cycloolefin-Polymere (COP)
- 3.1.17. Cycloolefin-Copolymere (COC)
- 2.4.35. Extractable elements in plostic materialsfor pharmaceuticol use
The new Ph. Eur. chapters give specifications for COC / COP materials, used, for example, in the manufacture of prefillable syringes. According to Pharmeuropa, they “follow the same structure as other general chapters on plastic materials in Ph. Eur. Subsection 3.1.”. However, there are two major changes in relation to the existing chapters:
- 3.1.16. Cycloolefin-Polymere (COP)
- 3.1.17. Cycloolefin-Copolymere (COC)
- 2.4.35. Extractable elements in plostic materialsfor pharmaceuticol use
The new Ph. Eur. chapters give specifications for COC / COP materials, used, for example, in the manufacture of prefillable syringes. According to Pharmeuropa, they “follow the same structure as other general chapters on plastic materials in Ph. Eur. Subsection 3.1.”. However, there are two major changes in relation to the existing chapters:
- Additives.It is clarified that “The supplier of the material must be able to demonstrate that the qualitative and quantitative composition of each production batch complies with that of the type sample.”
- Extractable Elements: The proposed monographs include the testing for
- Specific elemental impurities,
- Elemental impurities that are common to various plastic materials currently on the market. They are to be controlled according to the new general Ph. Eur. chapter 2.4.35. Extractable elements in plastic materials.
In comparison, the new USP Chapter <661.1> Plastic Materials of Construction states: “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”.
This shortcut will provide a detailed update on the recent developments in the area of these plastic packaging materials.
Programm
- COP and COC Plastic Materials in the Pharmaceutical Industry
- Chemical and Physical Properties
- Application examples
- Pharmacopoeial Compliance Testing (USP / Ph. Eur.)
- Extractable Elements
- Question and Answers
- Chemical and Physical Properties
- Application examples
- Pharmacopoeial Compliance Testing (USP / Ph. Eur.)
- Extractable Elements
- Question and Answers
Weitere Informationen
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register.
Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate:
Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
Contacts:
Questions regarding content:
Dr Andrea Kühn-Hebecker, +49 6221 84 44-35, kuehn@concept-heidelberg.de
Questions regarding Organisation:
Ms Sonja Geppert, +49 6221 84 44-95, geppert@concept-heidelberg.de
Duration of the shortcut:1h 20m
Recorded in June 2020
Please note:
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
Teilnahmegebühr
| Regular Fee*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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Tel.: +49 6221 8444-0
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