Quality Reports

Fabric Certifications

1. AS 9100D
2. ISO/TS 16949:2016
3. ISO 9001:2015
4. ISO 14001:2015
5. OHSAS 18001:2007
6. TAF(ISO/IEC 17025:2015)

Product Certifications

1. NSF61 (USA Drinking Water)
2. WRAS (UK Drinking Water)
3. ACS (France Drinking Water)
4. W-270 (Germany Drinking Water)
5. KTW (Germany Drinking Water)
6. UL 157 (Automotive, Gasoline)
7. EN 549 (Pipes, Gas Appliances)
8. NORSOK M710 (RGD Material)
9. NACE TM0297 (TGD Material)
10. ROSH EU DİRECTİVE 2011/65/EU
11. REACH SVHC
12. ADI FREE

CFR 21 FDA 177.2600

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.

USP Class VI <88> (in vivo)

Rubber components used in medical equipment and devices for surgical application may come into direct contact with human tissue, and bio-compatibility is a requirement as stipulated by USP Class VI. The US Pharmacopeial sets the safety standards for the healthcare, food and medical technologies industries. The series of tests consist of six classes, and Class VI is considered the most thorough and stringent. The purpose of Class VI tests is to determine the absence of harmful chemicals that may migrate out of rubber materials giving rise to adverse health effects.

USP Class VI Chapter 88 refers to in vivo biological reactivity tests with the purpose of ascertaining the biological response effect of elastomeric materials on live animals (in vivo). USP <88> stipulates three testing requirements:

An extract of the material to be tested is prepared with specific extraction fluids like vegetable oil and polyethylene glycol, and injected in vivo into living specimens. Biological reactivity is recorded.

1) Systemic Injection Test

Intravenous injection with the prepared extract is conducted on live specimens (mice or rabbits). The specimens are observed for 72 hours and abnormal response to toxicity recorded.

2) Intracutaneous Test

Intracutaneous injection with the prepared extract is conducted on specimens to determine adverse skin reactions. Observation is for 72 hours and results are recorded.

3) Implantation

The material to be tested is implanted into the specimen, and the live tissue that is in contact with the test material is monitored for abnormal response for a duration of 120 hours.

European Framework Regulation EC 1935/2004

Food Contact Materials are used extensively on a daily basis as in the form of kitchenware, packaging materials and equipment, tableware, food appliances and so on. The reaction of different materials varies when coming into contact with food, and their chemical constituents may cause harmful health effects if toxic contaminants are ingested.

Regulation (EC 1935/2004) establishes a standard of conformity for Food Contact Materials (FCM) that is legally binding and applied at the EU level. The regulation specifies the general human health safety requirement to ensure that materials that come into contact with food do not cause adverse health effects or alter the food composition, or introduce undesirable smell and taste into the food. A level is set on the acceptable “migration limits” of the Food Contact Material which is specific to different materials and in accordance to different temperature levels and other variables such as the pH level of the food.

Gmors manufactures a range of food grade rubber seals, o-ring and gaskets and custom-designed rubber components that is compliant to European Regulations EC1935/2004. Contact us with your equipment performance criteria and we will match your requirements from our extensive range of elastomeric compounds. Material range meeting the above regulations includes EPDM, FKM, NBR and much more.

Approval	Tested by	Specification	Compound Reference	Elastomer Compound	Shore Hardness	Color
FDA 21 CFR	Internal approval	§ 177.2600		NBR	From Shore A 60~90	Customized
FDA 21 CFR	Internal approval	§ 177.2600		EPDM	From Shore A 60~90	Customized
FDA 21 CFR	Internal approval	§ 177.2600		VMQ	From Shore A 60~90	Customized
FDA 21 CFR	Internal approval	§ 177.2600		FKM	From Shore A 60~90	Customized
EC 1935/2004	SGS Taiwan	ResAP(2004)4	E7083AA	EPDM perox.	70 ±5 Shore A	Black
EC 1935/2004	SGS Taiwan	ResAP(2004)4	N7041AA	NBR sulf.	70 ±5 Shore A	Black
EC 1935/2004	SGS Taiwan	ResAP(2004)4	V7502AA	FKM bisphenol	75 ±5 Shore A	Black
USP Class VI – 121 °C	Eurofins	Chapter 88 (in vivo)	V7092AP	FKM bisphenol	70 ±5 Shore A	White
USP Class VI – 121 °C	Eurofins	Chapter 88 (in vivo)	E7003AP	EPDM perox.	70 ±5 Shore A	White