Why Kalrez® FFKM Parts Are the Perfect Fit for Pharmaceutical Production and Medical Packaging
Pharmaceutical production and medical packaging demand the highest levels of safety, cleanliness and efficiency. These processes often involve aggressive chemical environments and high temperatures that degrade ordinary seals. PTFE has been the material of choice, but it can creep and cold flow, which can lead to a loss of seal function.
DuPont™ Kalrez® perfluoroelastomer (FFKM) parts provide best in class chemical resistance, outstanding thermal and steam resistance and low contamination from extractables. Here are five reasons why Kalrez® parts are ideally suited for demanding pharmaceutical and medical packaging processes that require FDA compliance.
1. Best In Class Chemical Resistance
Kalrez® FFKM parts are unrivaled in the market when it comes to chemical resistance. They resist attack from more than 1,800 chemicals, solvents and plasmas while retaining high levels of elasticity and recovery—even after long-term exposure to elevated temperatures. They are designed to resist swell when exposed to steam, sodium hydroxide, concentrated nitric acid, ethylene diamine, and many other chemicals and solvents.
2. Outstanding Thermal & Steam Resistance
Pharmaceutical manufacturing often involves high temperatures, while medical packaging requires steam for sanitation and often adhesion. Kalrez® parts are designed for stability in high temperature environments, including steam, steam cycling and hot water.
Even after long-term exposure to elevated temperatures, Kalrez® FFKM seals retain elasticity and recovery properties better than other high temperature elastomers. They resist embrittlement, hardening, volume swell, creep and cold flow—common causes of premature seal failure.
3. Increased Cleanliness, Safety & Process Purity
When seals fail, chemical substances or even pieces of the spent seal itself can contaminate the product. In a pharmaceutical or medical process, this is unacceptable.
Due to their chemical and heat resistance, Kalrez® FFKM parts reduce this risk of chemical exposure from seal degradation and failure. They offer low contamination from extractables and provide lower outgassing in vacuum sealing. Kalrez® delivers longer seal life compared to lower performing elastomers, improving productivity, efficiency, safety and cleanliness.
4. Specialty Compounds To Meet Stringent Regulations
The pharmaceutical industry must meet some of the world’s most stringent processing regulations. Kalrez® parts are available in speciality compounds that pair outstanding chemical resistance with the cleanliness standards required for pharmaceutical production. Expert use of proprietary polymers, cure systems, fillers and additives result in an excellent balance of finished properties.
White product for use in food handling and pharmaceutical applications where FDA and/or USP <87> and <88> Class VI compliance are required.
Grey product for use as sanitary seals in food handling, beverage, and pharmaceutical applications where FDA, USP <87> and <88> Class VI compliance are required.
Meets Japan Pharmacopoeia, edition 16*.
Black product specifically developed for use in high volume medical packaging and disposable devices.
Visit our Kalrez® Life Sciences Products page for more information on each.
5. Wide Range of Products, Shapes & Applications
Kalrez® parts include:
- Sanitary seals
- Custom parts
Kalrez® applications for pharmaceutical production include:
- Safety valves
- Butterfly valves
- Mechanical seals
- Sanitary seals
Kalrez® medical packaging applications include:
- Aerosol rings
- Needle covers
- Serum stoppers
- Infusion hangers
Not all parts and shapes available in all compounds.
C&B Equipment Is a Licensed Kalrez® Distributor
Kalrez® parts, with their long seal life, chemical resistance and high temperature resistance, are the perfect fit for the pharmaceutical and medical industries.
C&B Equipment is proud to be a Licensed Distributor of Kalrez parts®. The superior performance of these seals helps you increase your uptime—the mission that guides everything we do.
A dedicated seal expert can help you select the product that will optimize safety and performance while meeting industry requirements. For personal assistance in selection, contact our Kalrez® expert now.