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GMP FDA Certified Sterile LDPE Film For Pharmaceutical Use Customizable Size And Gamma Sterilization

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GMP FDA Certified Sterile LDPE Film For Pharmaceutical Use Customizable Size And Gamma Sterilization

Brand Name:	Hagilin
Model Number:	Customerized
MOQ:	5000pcs
Price:	Negotiable
Payment Terms:	L/C,T/T
Supply Ability:	8000ton/year

Detail Information

Product Description

Detail Information

Place of Origin:

China

Certification:

ISO FDA GMP

Productname:

Sterile LDPE Film

Usage:

Pharmaceutical

Moistureresistance:

High

Size:

Customizable

Compliance:

FDA GMP ISO Approved

Color:

Transparent

Material:

LDPE (Irradiated Low-Density Polyethylene)

Odor:

Packaging Details:

Double LDPE Bags+Sterile Bags(Carton)

Supply Ability:

8000ton/year

Highlight:

sterile ldpe film

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Product Description

Sterile Pharmaceutical LDPE Film - GMP/FDA Certified for API & Excipient Transfer

Product Specifications

Base Material: High-purity pharmaceutical-grade LDPE

Core Advantages: Pre-sterilized (EO/Gamma), contaminant-free, excellent flexibility

Compliance: GMP ISO FDA Certified

Target Application: Transfer of APIs, pharmaceutical excipients, and bulk drug substances

Sterility Level: Validated sterilization process

Custom Options: Thickness (0.03mm-0.2mm), width (100mm-1200mm), roll length

Safety Traits: No plasticizers, low extractables, biocompatible, non-toxic

Production Standard: Class C+A clean room manufacturing

Product Overview

For the transfer of APIs (Active Pharmaceutical Ingredients) and pharmaceutical excipients, maintaining sterility and preventing cross-contamination is essential. Traditional non-sterile films or low-quality LDPE materials often fail to meet these critical requirements, potentially leading to batch rejection, regulatory penalties, and compromised drug safety.

Our Sterile Pharmaceutical LDPE Film is specifically engineered to address these challenges, providing a reliable solution for the safe transfer of high-value APIs and excipients. Manufactured entirely in a Class C+A clean room environment, the film undergoes a validated gamma ray sterilization process to achieve the required sterility assurance level, eliminating pre-transfer contamination risks throughout your pharmaceutical supply chain.

Crafted from high-purity pharmaceutical-grade LDPE resin, this film is free of plasticizers, heavy metals, and harmful additives. Its low extractable profile ensures no chemical leaching into transferred materials, preserving the purity and efficacy of APIs and excipients. The film's excellent flexibility and tear resistance allow it to adapt to various transfer equipment while maintaining structural integrity, preventing spills and cross-contamination during handling operations.

The smooth surface minimizes material adhesion, reducing product waste and ensuring maximum yield of valuable pharmaceutical substances. Whether used for in-plant transfer, between production stages, or bulk shipment of APIs and excipients, this sterile LDPE film delivers consistent performance, regulatory compliance, and operational confidence for your critical pharmaceutical processes.

Key Features

Validated sterilization process with gamma ray treatment
Manufactured in Class C+A clean room environment
Free from plasticizers, heavy metals, and harmful additives
Low extractable profile prevents chemical leaching
Excellent flexibility and tear resistance
Smooth surface minimizes material adhesion
Customizable dimensions to meet specific requirements
Compliant with GMP, ISO, and FDA standards

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Tyvek Lid

Easy Tear Packaging

Medical Silicone Tubing

TPE Medical Tubing

Oxide Coated Film Rolls

Pharmaceutical Aluminum Foil

Disposable Bioreactor Bags

Cryogenic Freezing Bags

Single Use Bioprocess Bags

Transfer Bag

LDPE Packaging Bag

Tropical Blister Foil

Cold Form Blister Packaging

PTP Blister Foil

products details

Tyvek Sterilization Bags

Easy Peel Pouch and Lid

Tyvek Lid

Easy Tear Packaging

Medical Silicone Tubing

TPE Medical Tubing

Oxide Coated Film Rolls

Pharmaceutical Aluminum Foil

Disposable Bioreactor Bags

Cryogenic Freezing Bags

Single Use Bioprocess Bags

Transfer Bag

LDPE Packaging Bag

Tropical Blister Foil

Cold Form Blister Packaging

PTP Blister Foil

GMP FDA Certified Sterile LDPE Film For Pharmaceutical Use Customizable Size And Gamma Sterilization

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gmp ldpe film

gmp ldpe roll film