| MOQ: | 5000PCS |
| Price: | Negotiable |
| Payment Terms: | L/C,T/T |
| Supply Ability: | 8000Ton/year |
Product Description
LDPE (low-density polyethylene) bags are essential for the sterile transfer and packaging of APIs (Active Pharmaceutical Ingredients) and finished drug products. These bags meet stringent international and Chinese pharmacopeia standards, including USP, EP, and YBB.
A key advantage of these bags is their superior quality, often meeting or exceeding C+A class cleanliness requirements. They are specifically designed to have a very low level of insoluble micron particles, making them suitable for injection-grade products.
The bags can be sterilized using various methods, such as pressure steam, gamma irradiation, ethylene oxide (EO), and VHP (vaporized hydrogen peroxide). This versatility ensures compatibility with different manufacturing processes.
Product Parameters
|
Material |
Low-Density Polyethylene (LDPE) - Medical/Pharmaceutical Grade |
|
Standards |
YBB, EP, USP |
|
Cleanliness Class |
C+A Class (or higher) |
|
Sterilization Method |
Pressure Steam, Gamma (γ) Ray, Ethylene Oxide (EO), VHP |
|
Particle Count |
Meets injection standards for insoluble micron particles |
|
Application |
Sterile packaging/transfer of APIs and sterile drug products |
|
Key Properties |
Chemically Inert, Low Particulate Shedding, Heat-Sealable |
|
Dimensions |
Customizable (thickness, size, shape) |
Product Features
1.YBB standard.
2.(EP)EP standard.
3.(USP)USP standard.
4.C+A class.
5.Insoluble micron particle meet injection standard.
6.Sterilized by: pressure steam,γ ray(Gamma ray),EO and VHP etc.
7.Well-know brand in Shandong, China.
Product Application
LDPE (low-density polyethylene) packaging bags are indispensable in the drug manufacturing industry, primarily for maintaining the sterility of sensitive materials. Their main application is the safe and sterile transfer and packaging of Active Pharmaceutical Ingredients (APIs) and finished drug products.
In pharmaceutical facilities, these bags are crucial for internal logistics. They are used to move sterile powders, granules, and other drug components between different processing stages, such as from a reactor to a filling line, without contamination. This is vital for aseptic manufacturing processes where environmental control is paramount.
The bags' clean and inert properties also make them ideal for the final packaging of sterile drug products, particularly those intended for injection. They ensure that the contents remain free from harmful particles, microorganisms, and chemical leachates, thus guaranteeing product safety and integrity until they reach their final destination or are used in a clinical setting.
Product Advantage
LDPE (low-density polyethylene) packaging bags offer several key advantages that make them a standard in the industry. First and foremost, they meet rigorous quality standards like YBB, EP, and USP, ensuring they are safe for pharmaceutical use.
A critical feature is their cleanliness. These bags are manufactured to a C+A class standard and have a very low count of insoluble micron particles, which is essential for packaging injection-grade products. Their versatility in sterilization is another major benefit. They can be sterilized by multiple methods, including pressure steam, gamma rays, and EO, fitting seamlessly into various manufacturing processes.
Which provides manufacturers with reliability and peace of mind when handling sensitive and high-value sterile materials.