Silicone Weighing Bellows

Silicone Weighing Bellows – Food Contact Compliancy in general

Following independent testing we can confirm that our Silicone Elastomer Weighing Bellows with here under listed Article Numbers comply with the requirements of (EC)1935/2004 that all food contacting materials are “safe” to be used in repetitive contact with foodstuffs.

All of our Silicone Products are manufactured using European ingredients conforming fully to the requirements of REACH legislation. We confirm that our Silicone Products are carefully produced to comply with European Commission Regulations (EC)2023/2006 “good manufacturing practice for materials and articles intended to come into contact with food”.

In the current absence of EU legislation which specifies the requirements to prove that a silicone article is safe for food contact, we have conducted independent extraction testing to the requirements of FDA 21CFR 177.2600 “Rubber articles intended for repeated contact with foodstuff” + The German BfR XV “Food Standard for Silicones” + European Directive 2002/72/CE (UNE-EN 1186: Part 3 (aqueous food simulant) & Part 14 (fatty food simulant).

All of these tests conclude that our silicone rubber materials fully meet tangible food and drink industry extraction levels. In addition they are sufficiently inert to preclude substances being transferred to food in quantities large enough to endanger human health or to bring about an unacceptable change in composition of the food or a deterioration in its organoleptic properties.

Filcoflex B.V. hereby declares that below mentioned list (1) of Silicone weighing bellows in white, conductive black and asymmetrical conical version all comply with the following regulations (2) for repetitive contact with food and foodstuffs.

Silicone Weighing Bellows (1):

• Silicone Weighing Bellows White
• Silicone Weighing Bellows Conductive Black FDA
• Silicone Weighing Bellows Asymmetrical Conical

List of regulations to which the product complies (2)
FDA 21 CFR of the United States of America:

• 177.2600 (e)

European Union:

• (EC) 1935/2004
• (EC) 2023/2006

Migration Testing reports are available on both the White / Translucent Silicone compound for the spherical and the asymmetrical conical weighing bellows, aswell as the conductive black silicone compound for the spherical and asymmetrical conical silicone weighing bellows. All migration testing reports can be supplied with your request and your order.

To ensure and to be able to check afterwards if a batch of silicone bellows is in compliance with the documents and certificates supplied to you Filcoflex has a traceability programme in order. Of each production run samples are stored in containers so that up to 7 years after the production date the samples can be retested and compared in quality of the originally tested batch.

All silicone bellows of which the article numbers are listed in this document are suitable for contact with dry, aqueous and fatty foods defined by the FDA. As stated in 21 CFR 177.2600 it is recommended that the manufactured article is thoroughly cleansed prior to first use in contact with food.

Silicone Weighing Bellows – restriction or abscense of banned substances

Use of Banned Substance in Silicone Elastomer Weighing Bellows. None of the following substances are contained in; or used in the production process of any of the Silicone elastomer Weighing Bellows White Translucent with here under listed article numbers sold by Filcoflex:

Lead (Pb), cadmium (Cd), hexavalent chromium (Cr6+), mercury (Hg), phthalates, Bisphenol A, polycyclic aromatic hydrocarbons (PAH), Short chain chlorinated parafins (SCCP), brominated flame retardants, including polybrominated biphenyl ether, polybrominated diphenyl ether, octabromobiphenyl ether, pentabromobiphenyl ether and decabromodiphenyl ether.

These products and associated production processes are free of any animal derivatives and are latex free. None of the Silicone elastomer Weighing Bellows with here under listed article numbers.contain azodicarbonamide blowing agents. None of the Silicone elastomer Weighing Bellows with here under listed article numbers sold by Filcoflex contain Perfluoro octane Sulfonates (PFOS)

All Silicone elastomer Weighing Bellows White Translucent with here under listed article numbers sold by Filcoflex and their processing methods comply with the substance control requirements of the following directives; (Including amendments issued prior to the date of this statement):

• GADSL (formally known as ILRS List 101 and VDA list 232-101)
• EC Directive 76/769/EC
• EC Directive 2011/65/EC (RoHS)
• EC Directive 2002/96/EC (WEEE)
• EC Directive 2002/95/EC
• EC Directive 2000/53/EC (ELV)
• EC Directive 2003/11/EC
• EC Directive 2006/122/EC

And any subsequent modifications to these core directives released before the date below.

ATEX on SILICONE BELLOWS IN GENERAL

Translucent silicone weighing bellows can be used in explosion hazardous environments / ATEX zones 20, 21 and 22 as long as they are under 100mm length. Translucent silicone weighing bellows are not electrostatically dissipative.

Black conductive silicone weighing bellows can be used in explosion hazardous environments / ATEX zones 0,1,2 because they are electric conductive, as well as ATEX zones 20,21 and 22.

Please check with us for the specific conditions for each type of bellow to be used in your explosion safe design, we will happily provide you with the best recommendation and documentation.

Custom weighing Bellows

Silicone weighing bellows are made in standardized diameters and lengths. From 50pcs of one size they can be made to your design, fitting your required dimensions.

Chemical Resistance of Silicone

Silicone has a great resistance to:

• Ozon
• Aging
• Air
• Gas
• Most fluids
• Oxidadation
• Ultraviolet light (UV)
• Corona discharge
• Cosmic radiation
• Ionising radiation and weathering in general

Silicone has a poor resistance to:

• Oil, oily products, coffee oil
• Gasoline
• Acids

Silicone has an average resistance to:

• Lie

Production Method

All Filcoflex B.V.’s Silicone weighing bellows are compression molded food contact suitable silicone compound.

Drawing when in use

Parameter	Explanation
T OD A	Tube Outside Diameter
ID A	Inside Diameter
HC A	Hose Clamp width
SES A	Straight End Sleeve
CL	Length Weighing Bellow
BIHA	Length Between Tubes / Flanges
MAX	Maximum Available Build in Height
SES B	Straight End Sleeve
HC B	Hose Clamp width
ID B	Inside Diameter
T OD B	Tube Outside Diameter

Related Filcoflex Product Options

Quick Detach Couplings can be assembled on to the standard silicone weighing bellows using the well-known couplings like:

Silicone weighing bellows extended

Jacob coupling

• FDM, pressed on Jacob tubing flanges in either 25mm or 55mm length resulting in a either a 100 or 160mm total length

Tri-clamp coupling

• • LFR, pressed on Tri-clamp flanges in 28mm length, resulting in an overall length of 106mm
  • LFRc, pressed on Tri-clamp flanges with an inside conical milled tube connecting side that reduces any edges on the inside resulting in an even smoother inside bore than the LFR type, Tri-clamp flanges are 28mm length, resulting in an overall length of 106mm

• • CFL, bolted on conical Tri-clamp flanges for high grade pharmaceutical end users.

Related Products and Recommended Accessories

Quick Detach Couplings can be assembled on to the standard silicone weighing bellows using the well-known couplings like:

KLB20, 20mm Hoseclamps

HECHT Bellow, HECHT TRI-clamp bellow

Poly Urethane Weighing Bellows