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.
Solid Silicone Sheet
ElastaPro calendars European Pharmacopeia silicones into medical silicone sheeting that can be die cut into parts for peristaltic pumps, insulin pumps, and other types of medical devices and equipment. This process creates flexible, durable silicone sheets that can be precisely controlled for thickness, texture, and other properties.
This solid silicone sheet is available in:
- Durometers: 10 to 70 Shore A
- Thicknesses: .007” to .500”
- Widths: Up to 60”
- Colors: While typically translucent, various colors are availabe
These products are Made to Order and supplied in a gloss or matte finish.
Silicone Continuous Rolls
ElastaPro can also supply you with European Pharmacopeia silicone rolls that we can slit-to-width for automated cutting operations.
Uncured Silicone Compound
In addition to medical grade silicone sheets, ElastaPro offers uncured silicone compound that arrives ready-to-mold. Our materials are supplied rolled-up off the mill or in sheet form with a poly liner.
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.
FAQs for European Pharmacopeia Silicones
What is the European Pharmacopoeia and why does it matter for silicone materials?
The European Pharmacopoeia (Ph. Eur.) establishes quality and purity standards for materials used in pharmaceutical, medical, and bioprocessing applications. Silicone materials that meet Ph. Eur. requirements demonstrate low extractables, high purity, and suitability for regulated environments where patient or product contact occurs.
What tests apply to silicone under the European Pharmacopoeia?
Ph. Eur. Monograph 3.1.9 (Silicone Elastomer for Closures and Tubing) and related sections evaluate extractables, volatile content, transparency, mechanical properties, and biological reactivity. These tests ensure the silicone is safe for pharmaceutical closures, tubing, seals, and other contact applications.
Are ElastaPro’s European Pharmacopoeia silicones platinum‑cured?
Yes. ElastaPro formulates its European Pharmacopoeia‑compliant silicones using platinum‑cured systems to minimize extractables, eliminate peroxide by‑products, and support the purity required for pharmaceutical and bioprocessing applications.
How do European Pharmacopoeia silicones compare to USP Class VI and ISO 10993 silicones?
European Pharmacopoeia standards focus on pharmaceutical contact safety, while USP Class VI and ISO 10993 address broader medical biocompatibility. Many pharmaceutical and medical device manufacturers use all three standards together to support global regulatory submissions and risk assessments.
What applications commonly use European Pharmacopoeia‑compliant silicone?
Typical uses include pharmaceutical stoppers and closures, bioprocessing tubing, pump components, sanitary gaskets, fluid‑handling systems, and any application requiring low extractables and high‑purity elastomers.
What temperature range can European Pharmacopoeia silicone withstand?
ElastaPro’s Ph. Eur.‑compliant silicones typically operate from −80°F to +450°F, with intermittent resistance up to 500°F. This supports sterilization methods such as autoclaving, dry heat, and repeated thermal cycling.
What sizes, durometers, and thicknesses are available?
ElastaPro produces European Pharmacopoeia‑compliant silicone in durometers from 10–70 Shore A, widths up to 60 inches, and thicknesses from 0.007 to 0.500 inches. Custom dimensions and formulations are available for specialized pharmaceutical and bioprocessing requirements.
Does European Pharmacopoeia compliance guarantee FDA or ISO compliance?
Not automatically. Each standard evaluates different aspects of purity and biocompatibility. However, many formulations are engineered to meet Ph. Eur., USP Class VI, ISO 10993, and FDA 21 CFR 177.2600 simultaneously to support global regulatory needs.
Can ElastaPro provide documentation for European Pharmacopoeia compliance?
Yes. ElastaPro provides documentation confirming that the silicone formulation meets the relevant European Pharmacopoeia monograph requirements, including extractables and purity testing.
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.
