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ASO High Clean Poly Bag

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ASO High Clean Poly Bag

High Clean Poly Bag is a clean plastic bag with even better cleanliness than the Clean Poly Bag. Particles (with a particle size of 2 to 40 µm) on the inner surface of the bag are controlled on a lot-by-lot basis using a liquid-borne particle counter. These bags can be used as packaging for products that have a more stringent cleanliness requirement.

Major featuresCleanHighly cleanStandard sizeSterilizedAntistaticUV protection

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Overview

High Clean Poly Bag is a clean plastic bag with even better cleanliness than the Clean Poly Bag. Particles (with a particle size of 2 to 40 µm) on the inner surface of the bag are controlled on a lot-by-lot basis using a liquid-borne particle counter. These bags can be used as packaging for products that have a more stringent cleanliness requirement. High Clean Poly Bag has been certified to comply with the Japanese Pharmacopoeia as well as other international standards, including the USP, EP, and FDA regulations. We also provide products with a Type III DMF registration. Additive-free radical polymerization type low density polyethylene (LDPE) is used as the raw material, which makes the product free from particle formation due to the bleed-out of additives (formation of agglomerated powder).

Standard compliance

  Standards
Raw material Food Sanitation Act, Notification No. 201 of the Ministry of Health and Welfare
Food Sanitation Act, Notification No. 55 of the Ministry of Health and Welfare
High Clean Poly Bag Japanese Pharmacopoeia Japanese Pharmacopoeia, 16th edition Standard for polyethylene or polypropylene containers for aqueous injections
(transparency, appearance, heavy metals, lead, cadmium, residue on ignition, extractable substances, residue on evaporation, and cytotoxicity test)
USP <661> CONTAINERS
· Nonvolatile Residue
· Thermal Analysis
· Buffering capacity
· Heavy Metals
· Multiple Internal Reflectance

<87> Biological Reactivity Tests, Vitoro
European
Pharmacopoeia
3.1.4 (Materials Used For the Manufacture Of Containers)
FDA CFR21 177.1520 (c) 2.2
Type III DMF registration (15685)*1
*1 Products with a DMF registration have slightly different specifications. Please contact our sales representative for more details.

Heat-seal strength

The most common complaints about plastic bag products are defects such as "cuts" and "separation" in the sealed portions due to insufficient heat-seal strength. Our production equipment employs a unique "cut-and-seal method" that provides improved seal strength and stability compared to the conventional heat-seal method.

  1st specimen 2nd specimen 3rd specimen
Both ends Center Both ends Both ends Center Both ends Both ends Center Both ends
Cut-and-seal method 28.0 27.4 28.6 28.5 29.2 27.7 27.9 28.9 26.8
Conventional method (hot plate bottom seal) 20.8 19.1 19.7 21.2 19.6 22.0 20.1 19.2 21.0
[Test conditions]
1. Bag size: 0.1mm×550mm×770mm 2. Raw material: Additive-free LDPE 3. The seal strength was measured in three sealed portions of three specimens.
* The above figures are measured, not guaranteed, values.

Comparison of particles on the inner surface

Common materials for the manufacturing of plastic bags include "low density polyethylene (LDPE)" and "linear low density polyethylene (LLDPE)."

LDPE is a very pure polymer immediately after polymerization. The formation of additive particles is inevitable for LLDPE, which is produced by ion polymerization. However, in order to improve film productivity and efficacy of the bag manufacturing processes, an "antioxidant (BHT)," fatty acid-based "lubricant," silica-based "anti-blocking agent," and other additives are added in quantities of several hundred to several thousand ppm.

Therefore, after the inflation and bag manufacturing processes agglomerated powder starts to form on the inner and outer surfaces of the bag due to the bleed-out of these additives from inside the film. As these surfaces will come in contact with the packaged products, the biggest challenge in standard polyethylene is to prevent additive particles forming as they inevitably contaminate the products at the time of filling or packaging.

These particles continue to bleed out from the plastic film over time. For example, you may have seen white powder adhering to the surface of plastic bags stored for as long as a year. This is due to the bleed-out of these particles. The following tables compare the numbers of particles measured on a standard plastic bag and our Clean Poly Bag. Relatively new plastic bags produced about one week before testing were selected.

Standard LLDPE bag
(0.1mm×500mm×850mm)
Particle size 2μm 3μm 5μm 10μm 25μm 40μm
Blank water Measured value 1 0 0 0 0 0
0 0 0 0 0 0
1 1 1 0 0 0
Maximum 1 1 1 0 0 0
Average 1 0 0 0 0 0
Minimum 0 0 0 0 0 0
Product Measured value 130,703 81,503 9,770 757 24 6
125,758 78,065 10,304 1,264 53 12
131,156 82,304 10,928 1,466 60 8
Maximum 131,156 82,304 10,928 1,466 60 12
Average 129,206 80,624 10,334 1,162 46 9
Minimum 125,758 78,065 9,770 757 24 6
High Clean Poly Bag
(0.1mm×450mm×600mm)
Particle size 2μm 3μm 5μm 10μm 25μm 40μm
Blank water Measured value 0 0 0 0 0 0
0 0 0 0 0 0
0 0 0 0 0 0
Maximum 0 0 0 0 0 0
Average 0 0 0 0 0 0
Minimum 0 0 0 0 0 0
Product Measured value 14 7 3 0 0 0
22 17 4 0 0 0
11 10 4 0 0 0
Maximum 22 17 4 0 0 0
Average 16 11 4 0 0 0
Minimum 11 7 3 0 0 0
* The tables show measured, not guaranteed, values.
[Measurement method]
The bags were filled with 500 mL of dust-free water with a blank count close to zero and then the bag was tied at the top. Then, 10 mL of the water was taken out of the bag and the number of particles in this sample was counted. This measurement was repeated three times and the average value calculated. The total particle numbers are shown in the tables above.
* Measuring device: Particle counter from RION

Production environment

This product is produced in an ISO class 6 (class 1000) cleanroom.
In the production environment, bacteria inspections (falling and airborne) are conducted periodically. The products are also periodically inspected for microorganisms. Our workers wear clothing that completely covers the skin. Thus, we take all possible measures to ensure that the bags are suitable for use as packaging for pharmaceuticals or semiconductor devices.

Microorganism inspection
(1) Falling bacteria inspection (Koch method)

Measurement area General bacteria Fungi
A 0 0
B 0 0
C 0 0

(2) Airborne bacteria inspection (80 in 320 L) (Number of colonies/L)

Measurement area General bacteria Fungi Viable bacteria count
AreaA 0.0000 0.0000 0.0000
AreaB 0.0000 0.0000 0.0000

(3) Product inspection; washout method (2000 cm³)

Product name General bacteria Fungi
High Clean Poly Bag
(0.1mm×550mm×700mm)
0 0

Packaging

Packaging is an important factor in maintaining the cleanliness of clean plastic bags. As the inner packaging bag of clean bags, which comes in contact with them, we use a clean bag of the same material to keep them clean. We can also deliver our clean bags in double or triple inner packaging so that they can be unpackaged in order in an anteroom.

As the outmost package, "UV Cut Clean Cloth Sheet" is used. With its excellent shock resistance, "UV Cut Clean Cloth Sheet" protects Clean Poly Bags in transit securely. This UV protection sheet cuts 99% of 380 nm and shorter wavelengths, which promote ultraviolet degradation, and protects plastic bags in storage from degradation by ultraviolet light from ultraviolet germicidal lamps.

The combustion catalysis effect of the sheet makes it an environmentally friendly, hybrid packaging material that, when incinerated, inhibits the production of dioxins from other waste (of course, this product does not produce dioxins) or reduces NOX in exhaust gas.

  Inner packaging method Outer packaging method
High Clean Poly Bag The product is put in a Clean Poly Bag and vacuum-seal (select from among single, double, and triple packaging). Wrapping in UV Cut Clean Cloth Sheet

Film properties

Measurement item 0.05mm 0.1mm Measurement method
Tensile strength
[N/mm³]
MD 28.9 28.0 JIS Z-1702
TD 18.9 22.9
Tensile elongation
[%]
MD 233 271 JIS Z-1702
TD 629 642
Tear strength
[N/mm]
MD 99.0 29.4 JIS K-7128
TD 56.2 37.9
Seal strength
[N/10mm]
9.1 19.5 Our measurement method
Oxygen permeability
[ml/m² · 24hr · Mpa]
38996 19701 JIS K-7126
Water vapor permeability[g/m² · 24hr] 9.23 4.72 JIS Z-0208
* The above figures are measured, not guaranteed, values.

Size/Specifications

This product is available in custom sizes.

We produce this product to suit your application.
Feel free to contact us.

Unfortunately, we cannot answer any telephone inquiries.
If you have any questions, please contact us through the website and we will reply to your inquiry by e-mail.
Thank you for your understanding.

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