PRODUCT
EXCELLEN™ for Medical Devices

PRODUCT

EXCELLEN™ for Medical Devices

What is Excellen™ for Medical Devices?

Excellen™ for Medical Devices is a polyolefin formed of a resin composition and additives under strict contamination control according to Japanese Pharmacopoeia. It is compatible with various sterilization methods including gamma ray sterilization.
Careful and strict control of the manufacturing process ensures high quality, and our logistics ensure safe product use.

Lineup

Types	Features	Applications
Polypropylene (PP)	Good compatibility with various sterilization methods; highly flexibile; good processability	IVD, infusion bottles, syringes, prescription bottles, medical procedure instruments, contact lens molds, and many others
Low Density Polyethylene (LDPE)	Highly flexible; good processability	Prescription bottles, eye drop containers, enema containers, infusion bags, buffer film, packing, nozzles, caps, and many others
Linear Low Density Polyethylene (VLDPE)	Softener; impact modifier	Infusion bottles, various parts, and many others

Grades

1. Polypropylene (PP)

Polypropylene			S131M2	FH3711F6	FH3471M	AR244M	W101M2
Item	Test Method	Unit	Random PP	Random PP	Random PP	Random PP	Homo PP
MFR	ISO 1133	g/10min	2	3	3	30	8
Melting Point	ISO 3146	℃	123	138	141	152	164
Density	ISO 1183	kg/m3	896	890	900	895	905
Tensile Yield Strength	ISO 527	MPa	19	20	23	31	37
Tensile Elongation at Break	ISO 527	％	500	480	470	520	90
Flexural Modulus	JIS K7171	MPa	540	600	750	1,300	1,800
Charpy Impact Strength	JIS K7111	kJ/m2	N.B.	36	12	5	5
Heat Deflection Temperature	JIS K7191	℃	57	59	64	84	107
Hardness	JIS K7202	R-scale	54	61	76	94	106
Recommendable Molding Method			Blow	Extrusion, Blow		Injection
Features			Highly transparent; highly flexible	Heat resistant; highly transparent; impact resistant; low particles	Heat resistant; highly transparent; radiation resistant	Heat resistant; highly transparent; radiation resistant	Heat resistant; high elastic modulus

The values above are standard values. They are not to be considered as sales specifications or guaranteed values.

2. Low Density Polyethylene (LDPE)

Low Density Polyethylene			F101-M	F102-M	F218-M	G201-M	G202-M	G401-M	L705-M	G801-M
Item	Test Method	Unit	F101-M	F102-M	F218-M	G201-M	G202-M	G401-M	L705-M	G801-M
MFR	JIS K7210-1 ^*1	g/10min	0.3	0.4	1	2	1.5	4	7	20
Density	JIS K7112	kg/m³	922	922	919	919	919	926	919	919
Tensile Yield Strength	JIS K7161 ^*2	MPa	20	22	16	16	17	16	14	13
Tensile Elongation at Break	JIS K7161 ^*2	%	650	740	700	600	600	550	550	550
Tensile Modulus	JIS K7161 ^*2	MPa	275	265	115	115	115	180	120	125
Flexural Modulus	ASTM D747	MPa	225	205	215	185	185	265	165	155
Durometer Hardness	JIS K7215	D	57	54	47	47	48	50	46	45
Environmental Stress Cracking Resistance	ASTM D1693 ^*3	hr	> 300	9	3.5	3.5	4	1	1.9	0.5
Vicat Softening Temperature	JIS K7206	℃	100	97	91	91	91	100	86	83
Melting Point	JIS K7121	℃	112	112	109	107	108	113	107	106
Brittle Temperature	JIS K7216	℃	< -65	< -65	< -65	< -65	< -65	< -65	< -65	-35
Example Applications			Buffer film; eye-drop containers	Enema containers	Medicine bottles	Enema containers; medicine bottles	Eye-drop containers	Ointment containers	Eye-drop containers	Enema containers; eye-drop containers

The values above are standard values. They are not to be considered as sales specification or guaranteed values.

*1 190℃, 21.2N
*2 Test Piece: Type No. 2, 500mm/min
*3 Constant Strain Method, Reagent: IGEPALTM CO-630 10％ Solution

3. Linear Low Density Polyethylene (VLDPE)

Linear Low Density Polyethylene			EUL731-M
Item	Test Method	Unit	EUL731-M
MFR	JIS K7210-1 ^*1	g/10min	10
Density	JIS K7112	kg/m³	895
Tensile Yield Strength	JIS K7161 ^*2	MPa	9
Tensile Elongation at Break	JIS K7161 ^*2	%	900
Tensile Modulus	JIS K7161 ^*2	MPa	－
Flexural Modulus	ASTM D747	MPa	54
Durometer Hardness	JIS K7215	D	37
Environmental Stress Cracking Resistance	ASTM D1693 ^*3	hr	> 2,000
Vicat Softening Temperature	JIS K7206	℃	52
Melting Point	JIS K7121	℃	114
Brittle Temperature	JIS K7216	℃	< -75
Example Applications			Modifier for PP

The values above are standard values. They are not to be considered as sales specification or guaranteed values.

*1 190℃, 21.2N
*2 Test Piece: Type No. 2, 500mm/min
*3 Constant Strain Method, Reagent: IGEPAL™ CO-630 10％ Solution

Medical Quality Management

The safety of Excellen™ for Medical Devices is confirmed through a variety of tests that comply with the Japanese law Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

1. Japan Pharmacopoeia Tests

Ashing Test
Residue on Ignition %	Heavy Metals μg/g	Pb μg/g	Cd μg/g
≦ 0.1	≦ 20	≦ 1	≦ 1

Elution Test
Appearance	Foaming min.	⊿pH	KMnO₄ Reducing Substance ml	Residue on Evaporation mg	UV spectrum absorbance
Appearance	Foaming min.	⊿pH	KMnO₄ Reducing Substance ml	Residue on Evaporation mg	220-240nm	241-350nm
Limpid and Colorless	PP ≦ 3 PE ≦ 2^*	≦ 1.5	≦ 1.0	≦ 1.0	≦ 0.08	≦ 0.05

All tests are mainly conducted according to Japanese Pharmacopoeia 17th revision.
(*Foaming test of PE is conducted according to NHI No. 336.)

2. Biological Safety Tests

Biological safety tests were conducted to evaluate criteria that were determined based on contact parts and accumulated contact time.

Test item	Results
Test item	G801-M	AR244M	FH3471M
Skin sensitization	No skin sensitization	No skin sensitization	No skin sensitization
Pyrogen	Negative	Negative	Negative
Acute Toxicity	Not observed	Not observed	Not observed
Blood Compatibility; Hemolytic Toxicity	No hemolytic toxicity	No hemolytic toxicity	No hemolytic toxicity
Cell Toxicity (V79 Cell)	Not observed	Not observed	Not observed
Intracutaneous Reactivity	Negative	Negative	Negative

Tests were conducted in accordance with NHI 0301-20.

Assuring Manufacturing and Logistics Control

Thoroughly controlled to prevent contamination during the manufacturing process.
Reduced risk of contamination from auxiliary materials and environment by using specialized packaging and over-cover
Dedicated storage area and shipping process

Medical PE bag; 25kg

One-way Plastic Pallet (1,400×1,100mm)
Medical One-way Flexible Container; 500kg

Running Plastic Pallet (1,100×1,100mm)

Minimum Order Quantity is 1 metric ton.

Medical Policy

Excellen™ for Medical Devices is produced under guidelines specifically designed for the manufacturing process, our quality control, our logistics, and our material handling of products used for medical purposes.

Notice

We must confirm the application for use in advance.
We are also reserve the right to decline sales for applications with very high PL risks. (e.g. implants or the like).

Inquiry

To Business & Products / SUMITOMO CHEMICAL