{"id":1149,"date":"2026-10-22T13:43:53","date_gmt":"2026-10-22T13:43:53","guid":{"rendered":"https:\/\/www.marcorubber.com\/blog\/?p=1149"},"modified":"2026-10-22T13:43:53","modified_gmt":"2026-10-22T13:43:53","slug":"elastomer-seal-materials-for-medical-device-pharmaceutical-processing","status":"publish","type":"post","link":"https:\/\/www.marcorubber.com\/blog\/?p=1149","title":{"rendered":"Elastomer Seal Materials for Medical Device & Pharmaceutical Processing"},"content":{"rendered":"

Pharmaceutical processing seals carry more responsibility than most. A single failed O-ring can contaminate a batch, stall a validated process, or put a patient at risk. As a result, these seals must resist potent APIs, survive repeated steam sterilization, and meet FDA and USP Class VI requirements. This article covers the elastomer seal materials that meet all three demands. It also explains which compounds hold up best through autoclave and steam-in-place cycles. For a broader look at material selection across industries, see our Complete Guide to Elastomer Seal Materials<\/a>.<\/span><\/p>\n

Best Chemical-Resistant Seals for Pharmaceutical Processing Equipment <\/strong><\/h2>\n

Pharmaceutical processing seals face three demands at once. They must resist process media and potent
\nAPIs. They must also survive aggressive cleaning and sterilization. Finally, they must meet regulatory
\nstandards. Marco’s Medical and Pharma Sealing Guide<\/a> covers the full compound list.<\/span><\/p>\n

For most water-based processes, EPDM is the workhorse. It handles hot water, steam, alcohols, and many
\nacids and bases. However, EPDM swells in oils and hydrocarbon solvents.<\/span><\/p>\n

When process chemistry is aggressive, FFKM perfluoroelastomer is the safest choice. For example, Markez\u00ae<\/a>
\nZ1318 was specifically developed to handle a wide range of active pharmaceutical ingredients and aggressive
\ncleansing agents, and it is FDA-compliant and USP Class VI. Likewise, Markez\u00ae Z1426<\/a> is a high-purity compound
\nbuilt to sanitary design standards. It resists strong acids, aggressive solvents, steam, and hot amines.<\/span><\/p>\n

For a lower-cost middle ground, consider FKM or FEP-encapsulated O-rings<\/a>. In addition, Marco offers sanitary
\ntri-clamp gaskets<\/a> in compliant elastomers for process piping.<\/span><\/p>\n

Elastomers Compatible With Steam Sterilization and Autoclave Cycles<\/strong><\/h3>\n

Steam is harder on seals than dry heat. It hydrolyzes many polymers and causes hardening and cracking. As
\na result, the best steam-resistant choices are:<\/span><\/p>\n