CFR 21 FDA 177.2600 Approved O-Rings

 
 
Twin Seal Tech Pvt. Ltd.
Warehouse Address – Plot No. 8, Warehouse
No-3B, Near Johnson Controls, Indialand Global
Industrial Park, Warehouse No. 3B, Near
Hinjawadi Phase-1, Pune – 411 057 India.
Tel: +91-20-6799 4400
www.fdao-ring.com
email ask@gmors.com

CFR 21 FDA 177.2600
USP Class VI <88> (in vivo)
European Framework Regulation EC 1935/2004

The FDA, or Food and Drug Administration, is responsible for granting approval to products used in the equipment for the processing or storage of food and consumables. Such requirements are commonly found in the pharmaceutical, beverage and dairy and food processing industries. FDA regulations are applied internationally as a standard for control due to its highly stringent approval process.

CFR 21 FDA 177.2600 regulates rubber components used in food processing equipment that comes into contact with the food. O-rings and rubber gaskets are components that are found in equipment for food and pharmaceutical processing and their use is governed by CFR 177.2600 requirements.

Food grade rubber sealing components are a crucial part of food processing equipment, and they are required to perform to expectations under harsh conditions during equipment operation as well as cleaning and sterilization. The desired characteristics include:

1. The ability to resist a broad range of chemicals and process media.

2. The ability to perform under high temperature conditions in the presence of aggressive chemical and process media, during the process of cleaning and sterilization.

3. Excellent mechanical properties.

FDA code pertaining to the application of FDA approved rubber stipulates that components of rubber that is meant for repeated use should not give rise to harmful health effects during the process of food production and manufacturing, preparation and treatment, processing, packaging, distribution and storage.

Gmors offers FDA 21 CFR approved Silicone rubber (VMQ), which is widely sold to manufacturers of food and beverage processing equipment around the world. With excellent chemical resistance and service temperature ranging from -50 to +232 degrees Centigrade, food grade silicone rubber VMQ is used extensively in a variety of food processing equipment.

However, Silicone VMQ may not be suitable for use in most CIP and SIP processes. Resistance to steam during equipment sterilization is a factor to be considered, and elastomers may also react differently to different types of chemical media used in cleaning. Contact us about your applications and our technical specialists will assist your with the selection of the right product to match your requirements.