Proteus® LSG HP PP-H

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

Natural,

Off White

Physical Form

Plates,

Rods

Odor

Odorless

Insoluble in

Water

Mechanical Properties

	Value	Units	Test Method / Conditions
Tensile Strength ⁶	34.0	MPa	ISO 527-1/-2 ⁷
Tensile Strain (elongation, at yield) ⁶	6.0	%	ISO 527-1/-2 ⁷
Tensile Strain (elongation, at break) ⁶	25.0	%	ISO 527-1/-2 ⁷
Tensile Modulus of Elasticity ⁶	1800.0	MPa	ISO 527-1/-2 ⁹
Compressive Stress (at 1% nominal strain) ⁶	18.0	MPa	ISO 604 ¹⁰
Compressive Stress (at 2% nominal strain) ⁶	27.0	MPa	ISO 604 ¹⁰
Charpy Impact Strength - Unnotched ⁶	120.0	kJ/m²	ISO 179-1/1eU
Charpy Impact Strength - Notched ⁶	12.0	kJ/m²	ISO 179-1/1eA
Charpy Impact Strength - Double 14° Notched	12.0	kJ/m²	ISO 21304-2
Flexural Strength ⁶	50.0	MPa	ISO 178 ¹²
Shore Hardness D ⁶ ¹⁴	72.0	—	ISO 868

Typical Properties

	Value	Units	Test Method / Conditions
Thermal Decomposition	min. 300	°C	—
Self Ignition Temperature	min. 400	°C	ASTM D 1929
Density	0.91	g/cm³	ISO 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

	Value	Units	Test Method / Conditions
Melting Temperature (DSC, at 10°C) ¹	165.0	°C	ISO 11357-1/-3
Coefficient of Linear Thermal Expansion (at -40 to 150 °C) ¹	60.0	μin./in./°F	ASTM E-831 (TMA)
Coefficient of Linear Thermal Expansion (at 23 to 100°C) ¹	150.0	μm/(m.K)	—
Heat Deflection Temperature (method A, 1.8 MPa) ¹	60.0	°C	ISO 75-1/-2
Continuous Allowable Service Temperature in Air (for 20 hrs) ¹ ³	90.0	°C	—
Flammability UL 94 (3 mm) ¹ ⁵	HB	—	—

Electrical Properties

	Value	Units	Test Method / Conditions
Surface Resistivity	1 x 10¹²	Ohm/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)

Radiation Resistance

Resistance of the life science grades to gamma radiation

• 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.