1-2ASO High Clean Poly Bag

ASO High Clean Poly Bag

Major features

Clean

Highly clean

Standard size

Sterilized

Antistatic

UV protection

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 for 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)

Standards compliance

Food Sanitation Act （Japan)	Standards and criteria for food and food additives, etc.
Food Sanitation Act （Japan)		Ministerial Ordinance on Milk and Milk products Concerning Compositional Standards, etc.
Japanese Pharmacopoeia	Polyethylene or poypropylene containers for aqueous injections.
USP	(661.1)Plastic Material of Construction
		(661.2)Plastic Packaging Systems for Pharmaceutical Use
		(87)Biological Reactivity Tests, In Vitro
21CFR(FDA)	§177.1520 (C）2.2
EP	(3.1.4)Polyethylene without additives for containers for parenteral preparations and for ophthalmic preparations.

※Some of above test contents are excerpted and tested.

※DMF TypeⅢ can also correspond. Please inquire.

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.

[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.

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 L-LDPE Bag

(0.1mm×500mm×850mm)

Particle size			2μm	3μm	5μm	10μm	25μm	40μm
Blank water	Measurement 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
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
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
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.

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