1-1 ASO Clean Poly Bag｜ASO Co., Ltd.

ASO Clean Poly Bag

Clean poly bags that combine

cleanliness ＆

cost performance.

Major features

Clean

Highly clean

Standard size

Sterilized

Antistatic

UV protection

Overview

Clean Poly Bag is a clean plastic bag with no visible foreign matter on the inner or outer surfaces. It has been certified to comply with the Japanese Pharmacopoeia and other standards. It is cost effective, and can be widely used as an inner packaging bag for various applications, including the pharmaceutical applications.

Additive-free low density polyethylene (LDPE) is used as the raw material.

You could prevent particle formation in the product( bleed-out of additives ) because of using Radical polymerization LDPE.

Standards compliance

Food Sanitation Act （Japan)	Standards and Criteria for Food and Food Additives, etc.
Japanese Pharmacopoeia	Polyethylene or Polypropylene Containers for Aqueous Injections.

* Some of the above test contents are excerpted and tested.

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 sealing 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]
　・Bag size: 0.1mm×550mm×770mm

　・Raw material: Additive-free LDPE

　・The seal strength was measured in three sealed portions of three specimens.
* The above figures are measured, not guaranteed, values.

Inner surface particle control

Common materials used for manufacturing plastic bags include low-density polyethylene (LDPE) and linear low-density polyethylene (LLDPE).

LDPE is a highly pure polymer immediately after polymerization.

In contrast, LLDPE, which is produced by ion polymerization, inevitably generates additive-derived particles. In addition, to improve film productivity and the efficiency of bag manufacturing processes, various additives such as antioxidants (BHT), fatty acid-based lubricants, and silica-based anti-blocking agents are typically added in amounts ranging from hundred to several thousand ppm.

As a result, after the inflation and bag manufacturing processes, these additives bleed out from within the film, leading to the formation of agglomerated particles on both the inner and outer surfaces of the bag. Since these surfaces come into contact with the packaged products, one of the major challenges with standard polyethylene is how to suppress the formation of additive particles that may contaminate the products during filling or packaging.

These particles continue to bleed out from the plastic film over time. For example, you may have noticed white powder adhering to the surface of plastic bags stored for about a year, which is caused by this bleed-out phenomenon.

To address these concerns, our High Clean Poly Bags are made from additive-free LDPE.

This allows safe use without concern for contamination of the contents due to bleed-out.

The table below compares the number of particles measured on standard plastic bags and our Bags.

Standard L-LDPE bag

(0.1mm×500mm×850mm)

Particle size			2μm	3μm	5μm	10μm	25μm	40μm
Standard L-LDPE Bag	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

Clean Poly Bag

(0.1mm×500mm×720mm)

particle size			2μm	3μm	5μm	10μm	25μm	40μm
Clean Poly Bag	Measured value	100	66	14	1	0	0
				101	66	14	0	0	0
				94	63	10	0	0	0
		Maximum	101	66	14	1	0	0
		Average	98	65	13	0	0	0
		Minimum	94	63	10	0	0	0

* Samples were selected from relatively new bags, approximately one week after production.

* The tables show measured, not guaranteed, values.

* Measuring device: Particle counter from RION
[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.

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
Area A	0.0000	0.0000	0.0000
Area B	0.0000	0.0000	0.0000

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

Product name	General bacteria	Fungi
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
Clean Poly Bag	The product is put in a Clean Poly Bag and vacuum sealed (both single and double packaging available)	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
Tensile strength [N/mm³]		TD	18.9	JIS Z-1702	22.9
Tensile elongation [%]	MD	233	271	JIS Z-1702
Tensile elongation [%]		TD	629	JIS Z-1702	642
Tear strength [N/mm]	MD	99.0	29.4	JIS K-7128
Tear strength [N/mm]		TD	56.2	JIS K-7128	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.

Go to the top of "Look for a product"