Pharmaceutical Industry's Stringent Requirements for O-ring Materials

The pharmaceutical industry has strict requirements for O-ring materials, mainly to ensure the safety, purity and performance of the product, in compliance with pharmaceutical production and regulatory standards. The following are key requirements and considerations:

1. Biocompatibility of O-ring materials

• O-rings must be made of biocompatible materials and will not react harmfully with substances in contact with drugs or equipment.

• Usually need to meet the biocompatibility test standards of ISO 10993 or USP Class VI.

2. Chemical inertness

• The material must have high chemical stability and cannot react with drugs, cleaning agents or sterilizing agents.

• Highly inert materials such as fluororubber (FKM), perfluororubber (FFKM), VMQ o-ring are usually selected.

3. High temperature and chemical resistance

• Pharmaceutical processes often involve high temperature sterilization (such as steam sterilization) and strong acid and alkali cleaning processes, and O-rings need to maintain performance under extreme conditions.

• The material must withstand CIP (cleaning in place) and SIP (sterilization in place) processes.

4. Low precipitation and no contamination

• O-ring materials must not release contaminants or soluble substances to avoid contaminating drugs.

• Must pass FDA food grade certification to ensure that the material is non-toxic and can be used in drug production.

5. Mechanical properties

• O-rings must have good elasticity and wear resistance to maintain performance for a long time in a sealed state.

• The material needs to have low compression set to extend service life.

6. Antimicrobial properties

• Some pharmaceutical environments may require antimicrobial properties to prevent microbial contamination.

7. Compliance with pharmaceutical standards

• Must meet multiple industry and international certifications, such as:

• FDA CFR 21.177.2600 (food contact materials)

• USP Class VI (biocompatibility)

• EU 1935/2004 (European food contact material regulation)

• 3-A sanitary standards (commonly used in the dairy and food industries)

• ISO 13485 (quality management system for medical devices)

8. Traceability and verifiability

• In the pharmaceutical industry, product traceability is critical. O-ring suppliers are required to provide detailed material batch reports and compliance certificates to ensure that the source of all materials is clearly traceable.

Conclusion

The pharmaceutical industry's stringent requirements for O-ring materials are designed to ensure long-term stability, safety and product-free sealing systems. When selecting the right O-ring material, process conditions, chemical compatibility and regulatory requirements must be considered to meet industry standards. Jinwoseal's O-rings are made from high-quality raw materials to ensure long-term use benefits. Each production process has a strict quality inspection procedure to ensure that each product can be effectively sealed. Come to Jinwo to find the sealing solution that suits you.