ABOUT

The product line: GYLON BIO-LINE ® & GYLON BIO-LINE® PLUS

When seeking materials resistant to acids, caustics and sensitive media, performing at demanding temperatures and pressures, established options are hardly present. The available elastomers generally fail in at least one of these requirements and conventional PTFE is not suitable due to its cold flow properties. The modified and restructured PTFE of the GYLON BIO-LINE® as well as the restructured PTFE of the GYLON BIO-LINE® PLUS are well-proven in the industries to meet all these criteria since many years. Not only providing safe and economical processes but also optimizing stock keeping.

GYLON BIO-PRO® & GYLON BIO-PRO® PLUS

Tri-Clamp connections are the standard connection in the food and pharmaceutical processing industries since many years. Seals of varying quality and materials are often used regardless of their suitability for constantly increasing operating parameters. GYLON BIO-PRO® and GYLON BIO-PRO® PLUS deliver best in class performance across all critical factors such as compliance, chemical compatibility, sealability, creep and dimensional stability.

BENEFITS

GYLON BIO-LINE®/GYLON BIO-LINE® PLUS –
Quality seals for the food and pharmaceutical industry

  • High resistance to almost all chemicals and temperature cycles
  • Reduced cold flow and decreased creep relaxation
  • Dimensionally stable – no intrusion or extrusion into the process flow
  • Universal with unlimited shelf life
  • Ideal for SIP & CIP processes

MATERIALS

GYLON BIO-LINE® Style 3504

Product solutions are:

 

GYLON BIO-PRO®, GYLON BIO-ASEPT®, GYLON BIO-ECO®, GYLON BIO-LOK®

Ideal for
  • Food
  • Beverage
  • Cosmetic
Composition PTFE with Aluminosilicate microspheres
Media Resistance Almost universal chemical resistance
Approvals and Certificates
  • EC1935/2004 incl. EC10/2011   (1)
  • USP Class VI <87, 88>
  • Meets FDA 21 CFR177.1550
  • NSF 61 Standard   (2)
  • 62.BfR
  • USP Part <31, 281, 661>
  • ADI free (TSE, BSE)
  • EMEA 410/01
  • Phthalate and softener free
  • TA-Luft incl. Blow-out Proof (Material only)
  • BAM
Continuous max. Temperature 260 °C / 500 °F
Minimum Temperature -268 °C / -345 °F
Maximum Pressure 55 bar / 800 psig
Key Attributes
  • Traceability optional (1): Batch number on the gasket
  • High resistance to almost all chemicals and temperature cycles
  • Reduced cold flow and decreased creep relaxation
  • Dimensionally stable – no intrusion or extrusion into the process flow
  • Universal with unlimited shelf life
  • Ideal for SIP & CIP processes

1) This material also is used within process and industries, which are not rated to EC 1935/2004 and only is delivered with traceability under request within ordering process.
2) Only possible under request within ordering process.

GYLON BIO-LINE® PLUS Style 3522

Product solutions are:

 

GYLON BIO-PRO® PLUS, GYLON BIO-ASEPT® PLUS, GYLON BIO-ECO® PLUS

Ideal for
  • Pharmaceutical
  • Bio-Pharmaceutical
  • Dairy
  • Food
  • Beverage
  • Cosmetic
Composition 100% PTFE – free of fillers and pigments
Media Resistance Almost universal chemical resistance
Approvals and Certificates
  • 3-A 20-27
  • EC1935/2004 incl. EC10/2011   (1)
  • USP Class VI <87, 88>
  • Meets FDA 21 CFR177.1550
  • NSF 61 Standard  (2)
  • 62.BfR
  • USP Part <31, 281, 661>
  • ADI free (TSE, BSE)
  • EMEA 410/01
  • Phthalate and softener free
  • TA-Luft incl. Blow-out Proof (Material only)
  • BAM
Continuous max. Temperature 260 °C / 500 °F
Minimum Temperature -268 °C / -345 °F
Maximum Pressure 55 bar / 800 psig
Key Attributes
  • Traceability by default: Batch number on the gasket
  • Hygienic design according to EHEDG
  • High resistance to almost all chemicals and temperature cycles
  • Reduced cold flow and decreased creep relaxation
  • Dimensionally stable – no intrusion or extrusion into the process flow
  • Universal with unlimited shelf life
  • Ideal for SIP & CIP processes

1) This material also is used within process and industries, which are not rated to EC 1935/2004 and only is delivered with traceability under request within ordering process.
2) Only possible under request within ordering process.

SOLUTIONS

GYLON BIO-LINE® and GYLON BIO-LINE® PLUS these are Sanitary and Hygienic PTFE Aseptic Gaskets in different designs for various requirements.

GYLON BIO-PRO®

GYLON BIO-PRO® is a preformed gasket manufactured from GYLON® Style 3504. This high performance gasketing product shows an excellent chemical resistance and is therefore suited to handle all CIP- and SIP cleaning processes. The dimensional stability (no cold flow, no intrusion/recession and no gap extrusion) is outstanding. GYLON BIO-PRO® is therefore especially in the Pharma- and Food industry the preferred choice and is ideal for product-contact applications.

Main Segments
  • Pharmaceutical
  • Food
Certificates/Declarations*
  • FDA 21 CFR177.1550
  • EC1935/2004 incl. EC10/2011
  • USP Class VI <87>, <88>
  • USP <31>,<281>,<661>
  • BAM tested
  • Phthalate free
  • Silicone free
  • ADI free (EMEA 410/01)
  • Hydrocheck
Key Benefits
  • High dimensional stability
  • Stopped cold flow
  • No intrusion/recession
  • No gap extrusion
  • Excellent chemical resistance
  • Masters all CIP- and SIP-cleaning processes
  • Excellent cleanability of gasket
  • Wide temperature range
  • High pressure & vaccum duties
Features*
  • Temperature: -268 °C to +260 °C
  • Pressure: up to 55 bar
  • Filler: Aluminosilicate microspheres
  • Production site: Germany

* Depending on product and application details.

GYLON BIO-PRO® PLUS

GYLON BIO-PRO® PLUS is a preformed gasket manufactured from GYLON® Style 3522. This high performance gasketing product is made of 100% pure PTFE and shows an excellent dimensional stability (no cold flow, no intrusion/recession, no gap extrusion). Because of the excellent hygienic design of the gasket (smooth surface, no dead-space formation, seal geometry) cleaning processes can be carried out effective and resource-efficient. GYLON BIO-PRO® PLUS is therefore especially in the Pharma- and Food industry the preferred choice and is ideal for productcontact applications.

Main Segments
  • Pharmaceutical
  • Dairy – Lactose
  • Food
Certificates/Declarations*
  • 3-A (Sanitary Standard)
  • FDA 21 CFR177.1550
  • NSF 61 Standard
  • EC1935/2004 incl. EC10/2011
  • USP Class VI <87>, <88>
  • USP <31>,<281>,<661>
  • 62. BfR
  • Phthalate free
  • Silicone free
  • ADI free (EMEA 410/01)
  • TA-Luft incl. blow-out proof
Key Benefits
  • 3-A Certified / Smooth surface (20-27)
  • Hygienic Design
  • Excellent cleanability of gasket (EHEDG Doc.2)
  • Traceability via batch number
  • High dimensional stability
  • Stopped cold flow
  • No intrusion/recession
  • No gap extrusion
  • Excellent chemical resistance
  • Masters all CIP- and SIP-cleaning processes
  • Wide temperature range
Features*
  • Temperature: -268 °C to +260 °C
  • Pressure: up to 55 bar
  • 100% pure PTFE (no filler)
  • Production site: Germany

* Depending on product and application details.

GYLON BIO-ASEPT®

GYLON BIO-ASEPT® is a preformed gasket manufactured from GYLON®Style 3504 (blue) to seal flange connections according to DIN 11853 (hygienic connections) and DIN 11864 (aseptic connections). This high performance gasketing product shows an excellent chemical resistance and is therefore suited to handle all CIP- and SIP-cleaning processes. The dimensional stability is outstanding and guarantees a flush mounting of the seal. GYLON BIO-ASEPT® is therefore especially in the Pharma and Food industry the preferred choice and is ideal for product-contact applications.

 

Main Segments
  • Pharmaceutical
  • Food
Certificates/Declarations*
  • FDA 21 CFR177.1550
  • EC1935/2004 incl. EC10/2011
  • USP Class VI <87>, <88>
  • USP <31>, <281>, <661>
  • BAM tested
  • Phthalate free
  • Silicone free
  • ADI free (EMEA 410/01)
  • Hydrocheck
Key Benefits
  • High dimensional stability
  • Stopped cold flow
  • No intrusion/recession
  • No gap extrusion
  • Excellent chemical resistance
  • Masters all CIP- and SIP-cleaning processes
  • Excellent cleanability of gasket
  • Wide temperature range
  • High pressure & vacuum duties
Features*
  • Temperature: -268 °C to +260 °C
  • Pressure: up to 55 bar
  • Filler: Aluminosilicate microspheres
  • Production site: Germany

* Depending on product and application details

GYLON BIO-ASEPT® PLUS

GYLON BIO-ASEPT® PLUS provides the highest industrial safety regarding resilience in operation. Due to its unique gasket shape, which is designed to adapt to the flange geometry, it seals perfectly even under drastic conditions. Its smooth surface constitution prevents germs from attaching and increasing. Additionally to all GYLON BIO-LINE® approvals and certificates GYLON BIO-ASEPT® PLUS is also compliant with the 3A Sanitary Standard 20-27.

 

Main Segments
  • Pharmaceutical
  • Food
Certificates/Declarations*
  • 3-A Certified / Smooth surface (20-27)
  • FDA 21 CFR177.1550
  • EC1935/2004 incl. EC10/2011
  • USP Class VI <87>, <88>
  • USP <31>, <281>, <661>
  • BAM tested
  • Phthalate free
  • Silicone free
  • ADI free (EMEA 410/01)
  • Hydrocheck
Key Benefits
  • High dimensional stability
  • Stopped cold flow
  • No intrusion/recession
  • No gap extrusion
  • Excellent chemical resistance
  • Masters all CIP- and SIP-cleaning processes
  • Excellent cleanability of gasket
  • Wide temperature range
  • High pressure & vacuum duties
Features*
  • Temperature: -268 °C to +260 °C
  • Pressure: up to 55 bar
  • Production site: Germany

* Depending on product and application details

GYLON BIO-ECO®

GYLON BIO-ECO® is a preformed gasket manufactured from GYLON ®Style 3504 to seal flange connections according to DIN 11851 and SMS 1149. This high performance gasketing product shows an excellent chemical resistance and is therefore suited to handle all CIP- and SIP-cleaning processes. The dimensional stability is outstanding and guarantees a flush mounting of the seal. GYLON BIO-ECO® is therefore especially in the Pharma- and Food industry the preferred choice and is ideal for product-contact applications.

 

Main Segments
  • Pharmaceutical
  • Food
Certificates/Declarations*
  • FDA 21 CFR177.1550
  • EC1935/2004 incl. EC10/2011
  • USP Class VI <87>, <88>
  • USP <31>, <281>, <661>
  • BAM tested
  • Phthalate free
  • Silicone free
  • ADI free (EMEA 410/01)
  • Hydrocheck
Key Benefits
  • High dimensional stability
  • Stopped cold flow
  • No intrusion/recession
  • No gap extrusion
  • Excellent chemical resistance
  • Masters all CIP- and SIP-cleaning processes
  • Excellent cleanability of gasket
  • Wide temperature range
  • High pressure & vacuum duties
Features*
  • Temperature: -268 °C to +260 °C
  • Pressure: up to 55 bar
  • Filler: Aluminosilicate microspheres
  • Production site: Germany

 * Depending on product and application details.

GYLON BIO-ECO® PLUS

Due to a restructured 100% PTFE in conjunction with ultra smooth surfaceconstitution GYLON BIO-ECO® PLUS provides unrivaled sealing and cleaning characteristics for the most critical process applications. Inhibited cold flow as well as almost universal chemical resistance provide a reliable solution for the most demanding production lines in the pharmaceutical industry.

 

Main Segments
  • Pharmaceutical
  • Food
Certificates/Declarations*
  • FDA 21 CFR177.1550
  • EC1935/2004 incl. EC10/2011
  • USP Class VI <87>, <88>
  • USP <31>, <281>, <661>
  • BAM tested
  • Phthalate free
  • Silicone free
  • ADI free (EMEA 410/01)
  • Hydrocheck
Key Benefits
  • High dimensional stability
  • Stopped cold flow
  • No intrusion/recession
  • No gap extrusion
  • Excellent chemical resistance
  • Masters all CIP- and SIP-cleaning processes
  • Excellent cleanability of gasket
  • Wide temperature range
  • High pressure & vacuum duties
Features*
  • Temperature: -268 °C to +260 °C
  • Pressure: up to 55 bar
  • Production site: Germany

* Depending on product and application details.

GYLON BIO-LOK®

Camlock connections are the standard connection for quick coupling inthe food industry as well as the chemical industry. GYLON BIO-LOK® is made of highly compressible and flexible material GYLON® Style 3504. The seals offer a high stability and provide a solid seal when assembled.

 

 

Main Segments
  • Food
  • Chemical
Certificates/Declarations
  • FDA compliant
  • NSF 61 Standard
  • EC 1935/2004*
  • EC 10/2011
  • 62.BfR
  • USP Class VI Chapter 87 & 88
  • USP Part 31, 281 & 661
  • BAM tested
  • ADI free (TSE, BSE)
  • Phthalate and softener free
Key Benefits
  • 100 % GYLON®: Higher material safety. No core material which could contaminate the processed media.
  • Stable dimensions: No extrusion, no cold flow, high recovery. Centered by outer ring. Higher flexibility for open/close processes
  • Temperature resistant: Can be used at all process temperatures even with high temperature fluctuations.
  • Chemical resistant: Almost universal chemical resistance while meeting Food & Pharma standards.
  • One seal for all chemicals and temperatures: Reduces stock and risk of improper installation.
  • Universal gasket with unlimited shelf life
  • Made in Germany
Features
  • Temperature – 210 °C to +260 °C
  • Pressure up to 10 bar

* Please note: As the product is also used within processes and industries, which are not rated to EC1935/2004, please indicate traceability
documentation needs at the time of order.

TESTS

How to get a grip on contamination through seals... (click for more information)

Contamination through seals! A horror for operators of any plant. But how to get a grip on it?

The high hygienic requirements in industry rightly demand cleaning processes that must be ever cleaner and faster.

One would like to counteract the danger of contamination by increasing the temperature or even the concentration of the cleaning agents. Besides, this would also shorten the cleaning time and the system would be ready for operation again sooner – but some components, which are actually of secondary importance, put the brakes on: the seals.

A confusing variety of qualities makes life difficult. How do you know when to use materials like MVQ silicone, NBR, HNBR, FKM, EPDM and why are there actually so many different ones? These rubber parts are quite soft and tend to grow strongly (intrusion) into the pipeline when heavily loaded at the limit, which leads to flow losses and dead spaces that pose an additional contamination risk.

Elastomer seal

  • ID Intrusion
  • Product accumulation
  • Bacteria formation

 

PTFE would be interesting here. It is not a rubber (elastomer), but a harder plastic (plastomer) and almost resistant to all chemicals. Unfortunately, this clever idea dies with PTFE’s own so-called cold flow. If too much force is applied, it flows away in all directions.

Traditional PTFE

  • ID recession or intrusion
  • Product accumulation
  • Bacteria formation

 

Yet seals would be an important factor in increasing productivity, support the maintenance of hygiene standards and would have a not inconsiderable influence on the economic efficiency of a plant.

What if the cold flow of PTFE could be defeated?

Garlock has already achieved this with its GYLON® material series. GYLON® flat gaskets have already overcome many critical challenges in industry. Among conventional sealing solutions, there are hardly any suitable materials that are resistant to acids and alkalis and can additionally be used at demanding temperatures and pressures.

Elastomers usually fail in at least one of these requirements and conventional PTFE in turn proves unsuitable because of cold flow. So if GYLON® could also be used in other geometries, the idea of a material that can be used for almost all applications would have been brought back to life.

We have thought about, discussed and researched this idea.

The result: GYLON BIO-LINE® for food applications and GYLON BIO-LINE® PLUS for the pharmaceutical sector. GYLON® has proven itself in intensive tests under the toughest conditions in both areas and has become a sought-after material to meet increased plant availability in the future. In addition, the GYLON BIO-LINE® and the GYLON BIO-LINE® PLUS not only ensure safe and economical processes, but also contribute to inventory optimisation.

Stopped cold flow is good, but does this also banish the problem of contamination by rubber of drastically narrowed pipelines?

GYLON BIO-LINE® and GYLON BIO-LINE® PLUS show clear superiority in dimensional stability. Rubber gaskets tend to swell out of joints (extrusion) under mechanical stress due to vibration and misalignment. Extruded rubber seals cause dead spaces that impair cleaning and worsen the sterilisation result. A risk of contamination due to residues on the sealing material is the result. GYLON BIO-LINE® and GYLON BIO-LINE® PLUS gaskets remain flexible, tight and reliably flush with the pipe bore even under high loads.

GYLON BIO-PRO® / GYLON BIO-PRO® PLUS

  • Smooth inner diameter
  • Easy cleaning
  • Dimensional stability

 

PTFE SEALINGS: Before and after with 5 Nm torque
PTFE SEALINGS: Before and after with 5 Nm torque

The values given in the illustrations represent the deviations of the measured inner diameters in each case:

  • Bar 1 (colour 1): Difference between the original inner diameter of the seal and the inner diameter of the seal after assembly.
  • Bar 2 (colour 2): Difference between the inner diameter of the gasket after assembly and the inner diameter of the gasket after exposure to heat in the assembled state.
  • Bar 3 (colour 3): Measured total seal intrusion = intrusion assembly + intrusion heat exposure.
ELASTOMER (70° Shore A): Before and after with 3 Nm torque
ELASTOMER (70° Shore A): Before and after with 3 Nm torque

The values given in the illustrations represent the deviations of the measured inner diameters in each case:

  • Bar 1 (colour 1): Difference between the original inner diameter of the seal and the inner diameter of the seal after assembly.
  • Bar 2 (colour 2): Difference between the inner diameter of the gasket after assembly and the inner diameter of the gasket after exposure to heat in the assembled state.
  • Bar 3 (colour 3): Measured total seal intrusion = intrusion assembly + intrusion heat exposure.

The results clearly show that GYLON BIO-PRO® PLUS has a comparatively very low swelling behaviour. In particular, the rubber gaskets and the PTFE/rubber gaskets show relatively high swelling behaviour, both after assembly at room temperature and after exposure to heat.

It was not taken into account that vibrations frequently caused by pumps, for example, can also lead to a loosening of the sealing connection and thus to a leak. Further tightening of the joint creates additional extrusion of the rubber into the pipeline.

If the temperature drops (shutdown of the system) and the rubber contracts as a result, it is torn off in the process. Rubber chunks then metastasise through the entire system. This results in contamination and a high demand for replacement seals.

Wouldn’t you also like to work contamination-free and future-proof in your plant?

Tri-Clamp, milk pipe and aseptic seals from the GYLON BIO-LINE® and GYLON BIO-LINE® PLUS series are available from Garlock and are available in all common standard dimensions (DIN 36676; ISO 2852; BS 4825; ASME-BPE). In addition, their performance is certified and supported in conformity with EC 1935/2004, EC 10/2011, USP Class VI, FDA, etc.

GYLON BIO-LINE® and GYLON BIO-LINE® PLUS – a clean thing.

➜ GYLON BIO-PRO® PLUS: Cleanability Test
According EHEDG guideline No. 2 in order to compare material cleanability

➜ GYLON BIO-PRO® PLUS: Intrusion Test
Compare the intrusion inside the Tri-Clamp after mechanical and thermal stress

INSTALLATION

GYLON BIO-PRO® Installation

GYLON BIO-PRO® and GYLON BIO-PRO® PLUS are universal sanitary gaskets meeting your most critical application requirements. Learn more about their installation here.

CASE STUDIES

GYLON BIO-LINE ®/ GYLON BIO-LINE® PLUS represent the optimal solution for many applications:

DOWNLOADS

Downloads

Catalogues

GYLON BIO-LINE® / GYLON BIO-LINE® PLUS | (English) | (Deutsch)

Flyer

GYLON BIO-PRO® | (English) | (Deutsch)
GYLON BIO-PRO® PLUS | (English) | (Deutsch)
GYLON BIO-ECO® | (English) | (Deutsch)
GYLON BIO-ECO® PLUS | (English) | (Deutsch)
GYLON BIO-ASEPT® | (English) | (Deutsch)
GYLON BIO-ASEPT® PLUS | (English) | (Deutsch)
GYLON BIO-LOK® | (English) | (Deutsch)

Case Studies

GYLON BIO-PRO® & GYLON BIO-ASEPT® – Distillation plant | (English) | (Deutsch)
GYLON BIO-PRO® – Saturated Steam Autoclaves | (English) | (Deutsch)
GYLON BIO-PRO® PLUS – Oncology Injectables | (English) | (Deutsch)
GYLON BIO-ECO® PLUS – Progressive cavity pump | (English) | (Deutsch)

Certificates

Declaration of Conformity FDA | (English) | (Deutsch)
Letter of Conformance - Animal Derivates Ingredients - ADI | (English) | (Deutsch)
Declaration of Conformity - Phthalate free, Bisphenol free | (English) | (Deutsch)

DIN EN 13555

GYLON® Style 3504 - 2mm
GYLON® Style 3504 - 3.2mm
GYLON® Style 3522 - 2mm

FOOD SAFE - EC1935/2004, EC 10/2011 conformity

GYLON BIO-LINE® Style 3504 | (English) | (Deutsch)
GYLON BIO-LINE® PLUS Style 3522 | (English) | (Deutsch)

TA Luft

TA Luft Certificate GYLON BIO‐PRO® | (English) | (Deutsch)
TA Luft Certificate GYLON BIO‐PRO® PLUS | (English) | (Deutsch)

Links

GYLON® Brand Page – Garlock Website | (English)
GYLON BIO-LINE® / GYLON BIO-LINE® PLUS – Garlock Website | (English)

How to find us

Garlock GmbH
Falkenweg 1
41468 Neuss
GERMANY

Contact

+49 2131 349-0

garlockgmbh@garlock.com

 

Garlock Global Website

www.garlock.com

 

Career Site Europe

www.garlock-karriere.de

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