European Pharmacopeia Silicones
European Pharmacopeia silicones meet the requirements of a Council of Europe standard for ensuring that materials are safe for pharmaceutical use. Ph. Eur monograph 3.19 applies to silicone elastomers for closures (containers) and tubing and includes requirements for both biocompatibility and chemical properties.
ElastaPro is a Made in USA manufacturer of European Pharmacopeia silicones. We offer these materials as solid silicone sheets, continuous rolls, and uncured compound. Our medical grade silicones also meet FDA Title 21 CFR 177.2600, USP Class VI, and ISO 10993 requirements. Contact us to request a quote or discuss your medical device or equipment application.
What is Ph. Eur Monograph 3.19?
Ph. Eur. monograph 3.1.9 refers to the European Pharmacopoeia general chapter titled “Materials Used for the Manufacture of Containers.” It outlines the requirements for materials used in pharmaceutical packaging, especially for containers that come into direct contact with medicinal products.
There are several key requirements for these European Pharmacopeia silicones. Materials must be clearly identified and additives must be tightly controlled. Depending on the application, USP Class VI or ISO 10993 testing may be required. In addition, materials must be compatible with sterilization methods such as autoclaving and gamma radiation.
Ask ElastaPro for European Pharmacopeia Silicones
Do you need European Pharmacopeia silicones for medical devices or equipment? Contact ElastaPro for specifications grade solid silicone sheets, continuous rolls, and ready-to-mold compounds. Our medical grade elastomers also comply with FDA Title 21 CFR 177.2600 regulations and USP Class VI and ISO 10993 standards.
