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Proteus® LSG HP PP-H

Proteus® LSG HP PP-H is a product available in the form of plates and rods and is well-suited for various applications. This material is known for its features, including low leachability, X-ray sterilizability, life science grade, gamma sterilizability, high purity, plasma gas sterilizability, chemical resistance, low moisture absorption, ethylene oxide sterilizability, biocompatibility, and low extractable. It comes in the colors off-white and natural and offers excellent resistance to chemical cleaning agents and zero moisture absorption. Its applications include equipment and parts in various industries.

Brand: Proteus (2 products)

Polymer Name: Polypropylene (unspecified)

Physical Form: Plates, Rods

Features: Biocompatible, Chemical Resistant, Ethylene Oxide Sterilizable, Gamma Sterilizable, High Purity, Life Science Grade, Low Extractables, Low Leachable, Low Moisture Absorption, Plasma Gas Sterilizable, X-Ray Sterilizable

Density:: 910.0 kg/m³

Tensile Modulus: 1,800.0 MPa

Color (Properties): Natural, Off White

Technical Data Sheet

Enhanced TDS

Knowde-enriched technical product data sheet

Identification & Functionality

Chemical Family
Polyolefins,
Polypropylenes (PP)
Polymer Name
Polypropylene (unspecified)
Technologies
Plastics
Product Families
Plastics — Parts, Shapes & Films

Features & Benefits

Labeling Claims
BSE-free,
Biocompatible,
TSE-free
Materials Features
Biocompatible,
Chemical Resistant,
Ethylene Oxide Sterilizable,
Gamma Sterilizable,
High Purity,
Life Science Grade,
Low Extractables,
Low Leachable,
Low Moisture Absorption,
Plasma Gas Sterilizable,
X-Ray Sterilizable
Product Highlights
  • Stock shapes are made from High Purity homopolymer polypropylene resin that has undergone additional filtration to remove the last remaining black particles, thus increasing purity.
  • Pre-assessed for biocompatibility at the stock shape level for wetted contact applications in bioprocessing according to USP VI and ISO 10993.
    • Sterilization via Ethylene Oxide, plasma, gamma and x-ray
    • Excellent resistance to chemical cleaning agents
    • Zero moisture absorption
    • Low levels of extractables and leachables

Applications & Uses

Markets
Industrial
Applications
Industrial — Chemical & Industrial Manufacturing
Equipment & Parts
Plastics & Elastomers End Uses
Filtration Plates,
Fluid Distribution Plates,
Impeller,
Mixers,
Valves
Plastics & Elastomers Processing Methods
Compression Molding,
Extrusion
Recommended Applications
  • Bioprocessing wetted contact applications (not intended for applications involving body contact)*.
  • This includes upstream applications in bioreactors (valves, mixers/ impellers), downstream applications in chromatography (fluid distribution plates),and filtration plates.

Properties

Color (Properties)
Natural,
Off White
Physical Form
Plates,
Rods
Odor
Odorless
Insoluble in
Water
Mechanical Properties
ValueUnitsTest Method / Conditions
Tensile Strength ⁶34.0MPaISO 527-1/-2 ⁷
Tensile Strain (elongation, at yield) ⁶6.0%ISO 527-1/-2 ⁷
Tensile Strain (elongation, at break) ⁶25.0%ISO 527-1/-2 ⁷
Tensile Modulus of Elasticity ⁶1800.0MPaISO 527-1/-2 ⁹
Compressive Stress (at 1% nominal strain) ⁶18.0MPaISO 604 ¹⁰
Compressive Stress (at 2% nominal strain) ⁶27.0MPaISO 604 ¹⁰
Charpy Impact Strength - Unnotched ⁶120.0kJ/m²ISO 179-1/1eU
Charpy Impact Strength - Notched ⁶12.0kJ/m²ISO 179-1/1eA
Charpy Impact Strength - Double 14° Notched12.0kJ/m²ISO 21304-2
Flexural Strength ⁶50.0MPaISO 178 ¹²
Shore Hardness D ⁶ ¹⁴72.0-ISO 868
Typical Properties
ValueUnitsTest Method / Conditions
Thermal Decompositionmin. 300°C-
Self Ignition Temperaturemin. 400°CASTM D 1929
Density0.91g/cm³ISO 1183-1
Water Absorption (after 24h immersion in water of 23 °C)0.1%ISO 62 ¹⁶
Water Absorption (at saturation in water of 23 °C)0.1%
Dynamic Coefficient of Friction (-)0.25-QTM 55007 ²⁰
Thermal Properties
ValueUnitsTest Method / Conditions
Melting Temperature (DSC, at 10°C) ¹165.0°CISO 11357-1/-3
Coefficient of Linear Thermal Expansion (at -40 to 150 °C) ¹60.0μin./in./°FASTM E-831 (TMA)
Coefficient of Linear Thermal Expansion (at 23 to 100°C) ¹150.0μm/(m.K)-
Heat Deflection Temperature (method A, 1.8 MPa) ¹60.0°CISO 75-1/-2
Continuous Allowable Service Temperature in Air (for 20 hrs) ¹ ³90.0°C-
Flammability UL 94 (3 mm) ¹ ⁵HB--
Electrical Properties
ValueUnitsTest Method / Conditions
Surface Resistivity1 x 10¹²Ohm/sq.ANSI/ESD STM 11.11
Note

Handling (Machining) :

  • During machining of the semi-finished products, evacuate swarf to prevent slipping or tripping hazard and observe the maximum allowable concentration of dust and
  • formaldehyde levels on the workplace which apply in your country.
  • Wear safety goggles during machining.

Storage:

  • The products shall be stored indoors in a normal environment (air at 10 - 30°C / 30 - 70% RH) and kept away from any source of degradation such as sunlight, UV-lamps, chemicals (direct or indirect contact), ionizing radiation, flames, etc.
  • Dimensional changes (camber, warpage, shrinkage …) of the products as well as slight color shifts of the external surfaces can occur with time.
  • The latter does generally not pose a problem in case of semi-finished products since the surface-layer is mostly removed anyway upon machining them into finished parts.

Safety measures:

  • Standard industrial safety recommendations shall be observed.
  • Temperatures above the melting temperature shall be avoided.

Regulatory & Compliance

Certifications & Compliance
FDA 21 CFR 176.170,
FDA 21 CFR 177,
FDA 21 CFR 177.1520,
FDA 21 CFR 178,
FDA 21 CFR 178.3297,
ISO 10993,
SARA 302,
SARA 304,
SARA 311/312,
SARA 313,
USP Class VI

Technical Details & Test Data

Material Selection

Biocompatibility Pre-assessment Table - Medical

  1. Cytotoxicity
Ref.: ISO 10993-5 and USP <87> Biological
Reactivity Tests, In Vitro Elution Test		 2. Sensitization
Ref. ISO 10993-10, Magnusson & Kligman
Maximization Method		 3. Intracutaneous Reactivity
Ref.: ISO 10993-10 and USP <88> Biological
Reactivity Tests, In Vivo – Intracutaneous Test		 4. Acute Systemic Toxicity
Ref.: ISO 10993-11 and USP <88> Biological
Reactivity Tests, In Vivo – Systemic Injection Test		 5. Implantation Test
Ref.: USP <88> Biological Reactivity Tests,
In Vivo – Implantation Test (7 days)		 6. Human blood compatibility
Ref.: ISO 10993-4, Indirect Hemolysis
(in vitro)		 7. USP-Physicochemical Tests for Plastics
Ref.: USP<661> Containers,
Ultra Pure Water extract, 70°C/24h		 USP Class VI
Conclusion from tests 3, 4 and 5

Intended applications of which the duration of
contact with human body tissue is limited to.
Proteus® LSG HP PP-H Shape tested (incl. raw materials) Not Tested Shape tested (incl. raw materials) Shape tested (incl. raw materials) Shape tested (incl. raw materials) Not Tested Shape testing pending/planned Shape tested (incl. raw materials)

None

Biocompatibility Pre-assessment Table - Bioprocessing

  USP Class VI
Conclusion from tests 3, 4 and 5		 Animal Free Origin (AFO) or EMA/410/01
Rev.3 (Absence of BSE/TSE)		 Food Contact – FDA
Ref.: USA FDA 21 CFR 177 and 178

Food Contact – EU
Ref.: Commission Regulation (EU)
No 10/2011
Proteus® LSG HP PP-H Shape tested (incl. raw materials) Absence TSE/BSE Shape compliant Raw material compliant

Sterilization Resistance

  Compatibility with some commonly used sterilization methods
Ethylene
Oxide gas		 Wet heat (steam)
121°C / 134°C		 Dry heat
160°C		 Plasma Gamma
irradiation		 X-ray
irradiation
Proteus® LSG HP PP-H Good Good / Poor

Poor

 Good Good Good

Chemical Resistance

 

  Weak (dilute) acids Strong acids Oxidising chemicals Weak (dilute) alkalis Strong alkalis Hot water (80°C) Steam Esters
(e.g. ethyl acetate)		 Ketones
(e.g. acetone)		 Aromatic hydrocarbons
(e.g. benzene, toluene)

Aliphatic hydrocarbons
(e.g. hexane, octane)
Proteus® LSG HP PP-H Resistant - In general acceptable Service Life Partially Resistant - Limited Service Life Non - Resistant Resistant - In general acceptable Service Life Resistant - In general acceptable Service Life Resistant - In general acceptable Service Life Resistant - In general acceptable Service Life Resistant - In general acceptable Service Life Resistant - In general acceptable Service Life Partially Resistant - Limited Service Life

Resistant - In General Acceptable Service Life

X-ray Transparency

Transparency of the life science grades to high energy radiation (Measured at 23°C on 12 mm thick test plates, applying radiation with an energy level of 59keV)

Altron™ LSG PC - X-ray transparency - 1

Radiation Resistance

Resistance of the life science grades to gamma radiation

Altron™ LSG PC - Radiation resistance - 1

  • Index 6 = 106Gy / 1MGy = 106Gy / 1 Gy = 100rad /
  • 100rad = 1J/kg / 1J/kg = 6.24.1012MeV/kg
  • X-rays energy ranging from 100eV to 100keV. Gamma radiation have energy greater than 100keV.
  • The Radiation Index (RI) is defined as the logarith, base 10, of the absorbed dose in Mega grays at which the flexural stress at break or flexural strain at break of the tested material is reduced to 50% of its original value, under specified conditions of irradiation (the most radiation-sensitive of these two properties is chosen as the reference critical property).

Storage & Handling

Storage and Handling Information

Handling (Machining) :

  • During machining of the semi-finished products, evacuate swarf to prevent slipping or tripping hazard and observe the maximum allowable concentration of dust and
  • formaldehyde levels on the workplace which apply in your country.
  • Wear safety goggles during machining.

Storage:

  • The products shall be stored indoors in a normal environment (air at 10 - 30°C / 30 - 70% RH) and kept away from any source of degradation such as sunlight, UV-lamps, chemicals (direct or indirect contact), ionising radiation, flames, etc.
  • Dimensional changes (camber, warpage, shrinkage …) of the products as well as slight colour shifts of the external surfaces can occur with time.
  • The latter does generally not pose a problem in case of semi-finished products since the surface-layer is mostly removed anyway upon machining them into finished parts.

Safety measures:

  • Standard industrial safety recommendations shall be observed.
  • Temperatures above the melting temperature shall be avoided.