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STI Home Page» Products » Hoses » Fluoropolymer (PTFE) » Smooth Bore » Pharmalex

 

PHARMALEX HOSE - See Also Pharmaline

 

Pharmalex is a very flexible, patented smoothbore PTFE lined hose product with a clear silicone rubber cover designed to replace conventional all-silicone rubber hoses in applications where the inner silicone rubber liner may be subject to a chemical reaction with fluids passing through. Pharmalex is a very flexible, patented smoothbore PTFE lined hose product with a clear silicone rubber cover. It is designed to replace conventional all-silicone rubber hoses in applications where the inner silicone rubber liner may be subject to chemical reaction with fluids passing through, which may either contaminate the fluid, or degrade the rubber liner.
   
APPLICATIONS
Generally, Pharmalex is designed for light duty applications, with low internal fluid or gas pressures.   Pharmalex is designed for use in high purity Pharmaceutical, Biotech, Chemical and Foodstuffs application areas, where ease of cleaning the hose is required, both internal and external.  It is also very suitable for use in other general industrial applications, particularly those where hot fluids or gases are being passed.

ALTERNATIVE PRODUCTS
Pharmaline is a higher pressure capable, heavier duty alternative to Pharmalex. Pharmaline includes an SS wire braid between the tube and a white silicone rubber cover.

HOSE TYPES, DESIGNS & APPROVALS
Pharmalex GP has a PTFE hose liner tube, manufactured from PTFE material in accordance with FDA requirement 21 CFR 177.1550.

Unlike silicone rubber lined hoses and tubing, Pharmalex can be steam sterilized any number of times, without degradation of the hose liner.
   

An antistatic PTFE option is also available, Pharmalex AS, using liner material in accordance with the FDA requirement 21 CFR 178.3297.

Both Pharmalex GP and Pharmalex AS have been tested and the PTFE liners comply with USP Class VI, including the Elution (Cytotoxicity) test.

Both include a Platinum Cured clear (transparent) silicone rubber cover (Post-cured 4 hours at 200˚C in accordance with requirements for USP Class VI). The Silicone Rubber material is in accordance with FDA requirement CFR-177-2600.

Alternative colors of the silicone rubber cover are also available, to special order.

ADVANTAGES OVER CONVENTIONAL HOSE DESIGNS
Pharmalex can be used to replace silicone rubber hoses and tubing, particularly where the much better chemical resistance and ease of cleaning of the PTFE hose liner is an advantage.
Unlike silicone rubber lined hoses and tubing, Pharmalex can be steam sterilized any number of times, without degradation of the hose liner.

Pharmalex can be used to replace conventional smoothbore PTFE lined hoses in applications where the much better flexibility of Pharmalex is an advantage.   Pharmalex can be used in low pressure, light duty applications in place of more expensive reinforced PTFE and Silicone hose designs.

PROPERTIES
Temperature Range: -60°c (-80°F) to +200°C (400°F).
Pressure vs Temperature - Pressure ratings are as listed up to 130°C (266°F), then reducing at 1% per 1°C (1.8°F) up to 200°C (400°F).
Vacuum - All sizes fully vacuum resistant up to 100°C.

FURTHER TECHNICAL INFORMATION
Further technical information related to PTFE material, Antistatic specifications, usage requirements and limitations, testing and flow rates etc. is available in the Bioflex and Corroflon Product Information pages on this website.

END FITTINGS
Sanitary and Mini Sanitary Triclamp (Triclover) fittings in 316SS, with bores polished to <0.375µm (<15µ in).

I-Line Fittings
Compression Fittings.
BSPT and NPT Fixed Male Pipe Fittings.
Flanges, Camlocks, DIN 11851, RJT, SMS, RJP and others to special order.

HOSE ASSEMBLIES
Pharmalex can be assembled using the same end fittings and ferrules as for Pharmaline.

IDENTIFICATION OPTIONS
Silicone encapsulated color coding, and / or text information to suit customers requirements.
'Flotag' RFID chip, programmed to suit customers requirements.   Unique Serial Numbers and other information for each hose, stamped on ferrules or SS tags, to give total traceability.

 
Hose Size Actual Hose ID O/D over
Silicone Cover
Minimum
Bend Radius
Maximum
Working
Pressure
Burst
Pressure
Weight per
Unit Length
in mm in mm in mm in mm PSI Bar PSI Bar lb/ft kg/mtr
1/4 6.4 0.270 6.8 0.433 11.0 1 1/4 30 109 7.5 435 30 0.06 0.09
3/8 9.5 0.375 9.5 0.575 14.6 1 1/2 38 87 6.0 348 24 0.09 0.14
1/2 12.7 0.500 12.7 0.740 18.8 2 1/2 63 84 5.8 334 23 0.14 0.21
3/4 19.0 0.750 19.0 1.040 26.4 4 100 62 4.3 247 17 0.21 0.32
1 25.4 1.000 25.4 1.336 33.9 6 150 52 3.5 203 14 0.33 0.49

   

GP GRADES


Purpose
GP is the ‘General Purpose’ grade, for use in all applications where fluids or gases are being conveyed which do not generate a risk of static charge development (see “AS”).

Design & Approval
GP Grade has a virgin PTFE liner, manufactured from hose grade PTFE which conforms to the requirements of FDA 21 CFR 177.1550.  Both the PTFE liner tube and the platinum cured silicone rubber cover have been tested and conform to the requirements of USP Class VI. Additionally, the PTFE liner tube meets the requirements of USP Class VI at 121˚C (250˚F)

 

Pharmaline hose (but not Pharmalex Hose) in sizes 3/4” and above includes a Grade 304 SS wire helically wound in the external convolutions, to reinforce the hose against kinking.

EC - Electrical Continuity (Also known as “Electrically Bonded”)
Electrical continuity requires that the hose assembly supplied is electrically continuous, or conductive, between metal end fittings at each end of the hose.  This can apply whether the hose is GP or AS grade.  The requirements for this are specified in the German
Document BRG 132 and EN ISO 8031:2009 Annex A, when tested in accordance with EN ISO 8031:2009 Clause 5, which requires that the resistance between end fittings shall be <102 ohms per assembly. For hose assemblies which meet this requirement a Grade "M" marking can be applied in accordance with EN ISO
8031:2009 Annex A if requested.

Pharmaline Hose Assemblies with crimped fittings are all electrically continuous.  Pharmaline hose assemblies with Relink fittings are not normally Electrically Continuous, but can be made EC by a special Assembly Procedure RRF-SA-001/2.

Pharmalex hose assemblies are not Electrically Continuous.

AS GRADES


Purpose
AS Grade is an essential requirement in applications where there is the risk of an electrostatic charge buildup on the inside surface of the PTFE tube which may then discharge through the tube wall. Media passing through which create such a risk are fluids which have a Conductance of less than 10-8 S/m (Siemens per Metre), or 104 pS/m such as fuels, solvents, freons, some WFI (ultra-pure “Water for Injection”) and nonpolar
organics which are being transferred at a medium to high flow velocity.

All twin or multi phase media, and any non-mixing media, such as powder in air, or water droplets in steam, in gases or in oil, also colloidal fluids constitute a particular hazard for static charge generation, and always require grade AS.

Design & Approval
AS Grade hose has an anti-static PTFE liner manufactured from FDA 21 CFR 177.1550 approved PTFE, and less than 2.5% of “high purity” Carbon Black material to FDA requirement 21 CFR 178.3297 and European Commission Directive 2007/19/EC. AS
Grade also conforms to the requirements of USP Class VI, at 37˚C (99˚F), 70˚C (158˚F) and 121˚C (250˚F).

Antistatic Hose Assemblies
When "AS" (Antistatic) grade hose is specified, then the hose or hose assembly supplied will be tested in accordance with EN ISO 8031:2009 Clause 7 using electrodes specified in EN ISO 8031:2009 Clause 4.2.2.2 d) (and Clause 4.2.2.2 e if the hose has an antistatic cover) and meet the Antistatic requirements
of EN ISO 8031:2009 Annex A. This requires, for an antistatic liner or antistatic cover, that the resistance between an appropriately placed foam electrode and a metallic end fitting will be between 103 to 108 ohms per assembly. For hose assemblies which meet these requirements an appropriate Grade "Ω" marking can be applied in accordance with EN ISO 8031:2009 Annex A if requested.

NOTE: When in service, at least one end fitting must be connected to earth, to permit dissipation of the static charge from the end fitting.

 

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