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Approvals - certification

adiADI free

Mad cow disease can lead to fatalities caused by Creutzfeldt-Jakob disease (CJD) where the consumption of BSE infected animals (mad cow disease) is the cause. Bovine Spongiform Encephalopathy literally turns the brains into a sponge full of holes: behavioural and motor disorders, nervousness and aggression are the result of the misfolding of a normal protein into an abnormal protein or prion, that eats away the brain cells. BSE can have an incubation period from 2 to 18 years. The disease will over the course of a few weeks lead to death. These prions are very resistant and steam at 133°C, 3 bar for 20 minutes is necessary in order to destroy them. This treatment is necessary to prevent the introduction of BSE prions at sites for the food, drink and pharmaceutical industry. Stearates, fatty acids or similar products can originate from agriculture or animal processing production. ERIKS has inspected its rubber hoses for the use of ingredients originating from animals in order to avoid the risk of BSE prion contamination. These qualities are certified with the “ADI-free” logo (Animal Derived Ingredients free).

USP

USP class VI

standards are controlled by the USP, a non-governmental organisation in the USA that strives to improve public health by disseminating clear specifications to the medical and pharmaceutical bodies and their subsidiaries.
USP class VI rubber compounds must be subjected to various test phases; if they fail just one of the tests, the compound does not qualify for USP class VI approval.

These approvals contain tests for:

  • Cytotoxicity
  • Hemolysis
  • Pyrogenicity
  • “sensitisation”

FDA

FDA - ‘FOOD & DRUG Administration’

The FDA sets the minimum requirements for the rubber compounds that are used in our hoses in order to ensure that foodstuffs, human and veterinary medicines, biological and medical products can be handled in a safe and efficient manner.

The FDA also ensures that the user can be addressed in an honest, accurate and very informative manner about these basic products in these compounds. CFR § 21.177.2600 specifies the relevant requirements for “rubber articles that are intended for repeated use”. These requirements contain a list of the ingredients that may be used for FDA approved rubber compounds. This list contains the types of rubber, accelerators, plastifiers and fillers,... which may be used in the various compounds. Certain ingredients also have quantitive limits on how much may appear in compounds.
The FDA does not actually certify products according to CFR § 21.177.2600. It is always the task of the product supplier to guarantee that the goods supplied comply with the FDA requirements.

Approvals

USP, EFSA, FDA, ACS, BfR, DVGW, KIWA, KTW, NSF, WRC

Certifications

ERIKS has a lot of compounds which are controlled by independent labs. They are mainly used in contact with potable water, and in the food and pharmaceutical industry.
ERIKS works more and more together with ISO / TS 16949 certified companies worldwide. PPAP papers are a normal procedure these PPAP papers are available on demand ».

USPUnited States Pharmacopeia (USP)
More info on USP
EFSAEuropean Food Safety Authority (EFSA)
FDAFood and Drug Administration (FDA)
BfRBundesinstitut für Risikobewertung (BfR)
adiAnimal Derived Ingredient Free (ADI)
3a3-A Sanitary Standards (3-A)
ACSAttestation de conformité sanitaire (ACS)
KIWAkiwa
KTWKunststoffe und Trinkwasser (KTW)
NSFNational Sanitation Foundation (NSF)
WRCWater Research Council (WRC)
adiAnimal Derived Ingredient Free (ADI)
3a3-A Sanitary Standards (3-A)
DVGWDeutsche Vereinigung des Gas- und Wasserfaches (DVGW)
adiAnimal Derived Ingredient Free (ADI)
3a3-A Sanitary Standards (3-A)
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This is a printed version of Industrial-Hoses.info of ERIKS nv.
© ERIKS nv, 2017.