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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)

PolypropyleneS131M2FH3711F6FH3471MAR244MW101M2
ItemTest MethodUnitRandom PPRandom PPRandom PPRandom PPHomo PP
MFRISO 1133g/10min233308
Melting PointISO 3146123138141152164
DensityISO 1183kg/m3896890900895905
Tensile Yield StrengthISO 527MPa1920233137
Tensile Elongation at BreakISO 52750048047052090
Flexural ModulusJIS K7171MPa5406007501,3001,800
Charpy Impact StrengthJIS K7111kJ/m2N.B.361255
Heat Deflection TemperatureJIS K719157596484107
HardnessJIS K7202R-scale54617694106
Recommendable Molding MethodBlowExtrusion, BlowInjection
FeaturesHighly 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 PolyethyleneF101-MF102-MF218-MG201-MG202-MG401-ML705-MG801-M
ItemTest MethodUnit
MFRJIS K7210-1 *1g/10min0.30.4121.54720
DensityJIS K7112kg/m3922922919919919926919919
Tensile Yield StrengthJIS K7161 *2MPa2022161617161413
Tensile Elongation
at Break
JIS K7161 *2%650740700600600550550550
Tensile ModulusJIS K7161 *2MPa275265115115115180120125
Flexural ModulusASTM D747MPa225205215185185265165155
Durometer HardnessJIS K7215D5754474748504645
Environmental Stress
Cracking Resistance
ASTM D1693 *3hr> 30093.53.5411.90.5
Vicat Softening TemperatureJIS K7206100979191911008683
Melting PointJIS K7121112112109107108113107106
Brittle TemperatureJIS K7216< -65< -65< -65< -65< -65< -65< -65-35
Example ApplicationsBuffer film;
eye-drop containers
Enema containersMedicine bottlesEnema containers;
medicine bottles
Eye-drop containersOintment containersEye-drop containersEnema 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
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
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
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

  1. Thoroughly controlled to prevent contamination during the manufacturing process.
  2. Reduced risk of contamination from auxiliary materials and environment by using specialized packaging and over-cover
  3. 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

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