Quick Detail
Material: Multi-layer Renolit 9101 film
Core Advantages: Double-welded seal (leak-proof), 3D structural design, wide compatibility, EO/Gamma sterile
Compliance: GMP, ISO FDA
Application: Storage & transfer of APIs, pharmaceutical liquids, cell harvests, intermediates
Key Features: Low residual liquid (<1% of volume), gamma-sterilized, double-layer sterile packaging
Custom Options: Capacity (50L-2000L),Connectors,Silicone tubing
Safety: Endotoxin <0.25 EU/mL, ADCF (animal-derived component-free), low extractables
Production Environment: C+A clean room (100% integrity testing)
Description
In biopharmaceutical and pharmaceutical production, the storage and transfer of APIs, cell harvests, and sensitive liquids demand containers that eliminate leak risks, preserve product purity, and adapt to large-volume workflows. Traditional 2D bags or single-welded 3D bags often suffer from seal failure (causing costly liquid loss) or poor structural stability (collapsing during transfer), while low-quality films may leach substances or fail biocompatibility tests—leading to batch rejection and regulatory non-compliance.
Our 3D Pharmaceutical Storage & Transfer Bags address these critical pain points with a focus on leak-proof reliability and versatility. The core innovation lies in the double-welded seal technology: both the bag body seams and port connections are welded twice using precision heat-sealing equipment, forming a robust, gap-free seal that undergoes 100% integrity testing (pressure and leak detection) before leaving the factory. This design eliminates leak risks even under full-volume loading (up to 110% of rated capacity) or during long-distance transportation.
Crafted from multi-layer biopharmaceutical-grade film (with ULDPE as the liquid contact layer), the bags offer excellent chemical compatibility—safe for APIs, acidic/alkaline 药液 (pharmaceutical liquids), and cell harvests without leaching or compromising cell viability. The 3D structural design (compatible with standard square/round support buckets) provides stable standing during filling and emptying, while the smooth inner surface minimizes residual liquid (≤1% of total volume), reducing product waste for high-value APIs.
Manufactured in a C+A clean room, the bags are pre-sterilized via gamma irradiation and packed in double-layer sterile packaging to maintain sterility until use. They meet strict safety standards: endotoxin <0.25 EU/mL (compliant with WFI requirements), ADCF materials, and low extractables—supporting regulatory compliance for biopharmaceutical processes. Whether for storing bulk APIs, transferring cell harvests between production stages, or transporting pharmaceutical intermediates, these double-welded 3D bags deliver reliable leak protection, product safety, and operational flexibility.