LeKrius^® Single-Use Mixing Bag

Proprietary high-performance film with ultra-low leak rate— designed to safeguard your bioprocess

The LeKrius® single-use bioprocess storage bag is a core independently developed product of LePure Biotech. It is manufactured using a fully independently developed multiple layer co-extruded film (LDPE/EVOH/ULDPE) and sterilized by gamma irradiation. The total film thickness reaches 400 m. The bag features extremely low gas/water vapor permeability, excellent mechanical and physical strength, broad chemical compatibility, and fully compliant biocompatibility, fundamentally eliminating the risks of fluid contamination, leachables/extractables, and leakage.

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Description

Features

Manufactured by in-house developed and produced LeKrius^®bioprocess film, DMF-filed, 400 m reinforced, free of Irgafos^® 168,with low extractables and leachables, low particulates and endotoxins. The bag product series is fully compliant with USP, EP,ISO and ASTM standards
Raw materials and entire manufacturing process are TSE/BSE-free
Mixing Types: magnetic coupling, levitated magnetic mixing,top-mounted mixing, etc.
Working Volume: 500 mL–4000 L; Sizes are fully customizable;Alternative filters, connectors, tubing and fittings are available
100% integrity tested
Gamma Irradiation Sterilization

Advantages

Compatible with most mainstream mixing systems; no equipment modification required, reducing process modification costs. Flexible selection of tubing, fittings and other components, suited to customers’ existing consumable systems
Compatible with high-salt and low-pH process fluids, suitable for multi-scenario applications
Full-stage and full-range compatibility (from R&D, pilot to commercial production stages), lowering operational costs
Modular design with diverse models adapts to different process complexities, streamlining the supply chain
Fully customizable bag body, feed ports, sensor ports, etc. to meet individual requirements precisely, with fast response and short lead times for custom orders
Local R&D and manufacturing with dual compliance and supply assurance, supporting long-term stable production
- In-house developed core film ensures a stable supply chain, consistent batch performance and reliable delivery
- DMF-filed film with complete compliance validation data supports global drug registration and mitigates compliance risks
- End-to-end technical support ensures stable process operation

Applications

Downstream Purification Process
- Preparation of buffer, acid and base for purification workflows
- Process fluid regulation (pH, conductivity, etc.) and temporary holding
Formulation & Fill
- Precision mixing for drug substance dilution and volume fine-tuning
- Conditioning and temporary holding of formulation intermediates
- Mixing and temporary holding of fill-ready drug products
ADC Drugs, Plasmids & Gene Therapy Applications
- Preparation and mixing of ADC drug, plasmid and gene therapy-related process fluids

Technical Parameters

Physical parameters

Test Standards	Test items	Test Results
ASTM-D6988	Film thickness test (μm) Compliant	Compliant
ASTM-882	Longitudinal (MD) tensile strength (MPa)	Compliant
ASTM-882	Transverse (TD) tensile strength (MPa)	Compliant
ASTM-F1306	Puncture strength (N)	Compliant
ASTM-D1709	Dart impact strength (J)	Compliant
ASTM-F392	Flex resistance	Compliant

Biocompatibility

Test Standards	Test items	Test Results
USP<87>	In vitro bioreactions	Compliant
USP<88> ClassVI	In vivo biological responses	Compliant
USP<661>	Testing of physical and chemical properties of plastics	Compliant

Cleanliness and performance testing

Test Standards	Test items	Test Results
USP<788>	Insoluble particle test	Compliant
USP<85>	Bacterial endotoxin test	Compliant
USP<790>	Visible particulate matter test	Compliant
USP<643>	Total Organic carbon (TOC) test	Compliant
USP<645>	Conductivity test	Compliant
ASTM F88	Heat seal strength test	Compliant

Ordering Information

PG & LG series

Product line	Product code	Volume	Inlet tubing configuration	Outlet line configuration	Sampling line configuration	Process interface configuration
Standard model	PG050-7K	50 L	1/2" × 3/4" LePure silicone tubing (50 cm)+CPC female connector	1/2" × 3/4" LePure silicone tubing (100 cm)+CPC male connector	1/8" × 1/4"LePure silicone tube (15 cm) +needleless sampling port	4" feeding port +clamp blind plate
	PG100-7K	100 L	1/2" × 3/4" LePuresi licone tubing (150 cm)+CPC female connector	1/2" × 3/4" LePure silicone tubing (150 cm)+CPC male connector
	PG200-7K	200 L
	PG400-7K	400 L
	PG650-7K	650 L
	PG1000-7K	1000 L
Universal model	PG050-6K	50 L	1/2" × 3/4" LePure silicone tubing (150 cm)+TC50+ clamp blind plate	1/2" × 3/4" LePure silicone tubing (150 cm)+TC50+ clamp blind plate	1/4" × 3/8"LePure silicone tube (20 cm) +needleless sampling port	4" feeding port +clamp blind plate PH×2
	PG100-6K	100 L
	PG200-6K	200 L
	PG400-6K	400 L
	PG650-6K	650 L
	PG1000-6K	1000 L
High-end model	PG050-8K	50 L	1/2" × 3/4" LePure silicone tubing (50 cm)+CPC female connector	Drain valve +1/2" × 3/4" LePure silicone tubing (100 cm)+CPC male connector	1/8" × 1/4"LePure silicone tubing (15 cm) +needleless sampling port	4" feeding port +clamp blind plate PH×2 Temperature electrode
	PG100-8K	100 L	1/2" × 3/4" LePure silicone tubing (150 cm)+CPC female connector	Drain valve +1/2" × 3/4" LePure silicone tubing (150 cm)+ CPC male connector
	PG200-8K	200 L
	PG400-8K	400 L
	PG650-8K	650 L
	PG1000-8K	1000 L
General-p urpose	LG050-1K	50 L	1/2" × 3/4" LePure silicone tubing (150 cm)+TC50+ clamp blind plate	1/2"× 3/4" LePure silicone tubing (150 cm)+TC50+ clamp blind plate	1/4" × 3/8"LePure silicone tube (20 cm)+ needleless sampling port	4" feeding port + clamp blind plate PH × 2
	LG100-1K	100 L
	LG200-1K	200 L
	LG400-1K	400 L
	LG650-1K	650 L
	LG1000-1K	1000 L
	LG1500-1K	1500 L
	LG2000-1K	2000 L	1" × 11/8" LePure silicone tubing (150 cm) +TC50+clamp blind plate	1" × 11/8" LePure silicone tube (150 cm) +TC50+clamp blind plate
	LG3000-1K	3000 L

DG series

Product line	Product code	Volume	Inlet tubing configuration	Outlet line configuration	Sampling line configuration	Process interface configuration
Standard model	DG050-8K	50 L	1/2" × 3/4" LePure silicone tubing (50 cm)+CPC female connector	1/2" × 3/4" LePure silicone tubing (100 cm)+CPC male connector	1/8" × 1/4"LePure silicone tube (15 cm) +needleless sampling port	4" feeding port +clamp blind plate
	DG100-8K	100 L
	DG200-8K	200 L	1/2" × 3/4" LePure silicone tubing (150 cm)+CPC female connector	1/2" × 3/4" LePure silicone tubing (150 cm)+CPC male connector
	DG500-8K	500 L
	DG1000-8K	1000 L
Universal model	DG050-7K	50 L	1/2" × 3/4" LePure silicone tubing (150 cm)+TC50+ clamp blind plate		1/4" × 3/8"LePure silicone LePure silicone needleless sampling port	4" feeding port +clamp blind plate PH×2
	DG100-7K	100 L
	DG200-7K	200 L
	DG500-7K	500 L
	DG1000-7K	1000 L
High-end model	DG050-9K	50 L	1/2" × 3/4" LePure silicone tubing (50 cm)+CPC female connector	Drain valve +1/2" × 3/4" LePure silicone tubing (100 cm)+CPC male connector	1/8" × 1/4"LePure silicone tubing (15 cm) +needleless sampling port	4" feeding port +clamp blind plate PH×2
	DG100-9K	100 L	1/2" × 3/4" LePure silicone tubing (150 cm)+CPC female connector	Drain valve +1/2" × 3/4" LePure silicone tubing (150 cm)+ CPC male connector		4" feeding port +clamp blind plate PH×2 Temperature electrode
	DG200-9K	200 L
	DG500-9K	500 L
	DG1000-9K	1000 L

FG series

Product line	Product code	Volume	Inlet tubing configuration	Outlet line configuration	Sampling line configuration	Process interface configuration
Standard model	FG050-7K	50 L	1/2" × 3/4" LePure silicone tubing (50 cm)+CPC female connector	1/2" × 3/4" LePure silicone tubing (100 cm)+CPC male connector	1/8" × 1/4"LePure silicone tube (15 cm) +needleless sampling port	4" feeding port +clamp blind plate
	FG100-7K	100 L	1/2" × 3/4" LePure silicone tubing (150 cm)+CPC female connector	1/2" × 3/4" LePure silicone tubing (150 cm)+CPC male connector
	FG200-7K	200 L
	FG500-7K	500 L
	FG1000-7K	1000 L
Universal model	FG050-6K	50 L	1/2" × 3/4" LePure silicone tubing (150 cm)+TC50+ clamp blind plate	1/2" × 3/4"LePure silicone tubing (150 cm)+TC50+ clamp blind plate	1/4" × 3/8"LePure silicone tube (20 cm)+ needleless sampling port	4" feeding port +clamp blind plate PH×2
	FG100-6K	100 L
	FG200-6K	200 L
	FG500-6K	500 L
	FG1000-6K	1000 L
High-end model	FG050-8K	50 L	1/2" × 3/4" LePure silicone tubing (50 cm)+CPC female connector	Drain valve +1/2" × 3/4" LePure silicone tubing (100 cm)+CPC male connector	1/8" × 1/4"LePure silicone tubing (15 cm) +needleless sampling port	4" feeding port +clamp blind plate PH×2 Temperature electrode
	FG100-8K	100 L	1/2" × 3/4" LePure silicone tubing (150 cm)+CPC female connector	Drain valve +1/2" × 3/4" LePure silicone tubing (150 cm)+ CPC male connector
	FG200-8K	200 L
	FG500-8K	500 L
	FG1000-8K	1000 L

MG series

Product line	Product code	Volume	Inlet tubing configuration	Outlet line configuration	Sampling line configuration	Process interface configuration
Standard model	MG100-14K	100 L	1/2" × 3/4" LePure silicone tubing (150 cm)+CPC female connector	1/2" × 3/4" LePure silicone tubing (150cm)+CPC male connector	1/8" × 1/4"LePure silicone tube (15 cm) +needleless sampling port	4" feeding port +clamp blind plate
	MG200-14K	200 L
	MG500-14K	500 L
	MG1000-14K	1000 L
	MG2000-14K	2000 L	1" × 11/8" LePure silicone tubing (150 cm)+ CPC female connector	1" × 11/8" LePure silicone tubing (150 cm)+ CPC male connector
	MG3000-14K	3000 L
Universal model	MG100-13K	100 L	1/2" × 3/4" LePure silicone tubing (150 cm)+TC50+ clamp blind plate	1/2" × 3/4" LePure silicone tubing(150 cm)+TC50+ clamp blind plate	1/4" × 3/8"LePure silicone tube (20 cm)+ needleless sampling port	4" feeding port + clamp blind plate PH×2
	MG200-13K	200 L
	MG500-13K	500 L
	MG1000-13K	1000 L
	MG2000-13K	2000 L	1" × 11/8" LePure silicone tubing (150 cm)+TC50+ clamp blind plate
	MG3000-13K	3000 L
High-end model	MG100-15K	100 L	1/2" × 3/4"LePure silicone tubing (150 cm)+CPC female connector	Drain valve +1/2" × 3/4"LePure silicone tubing (150 cm)+ CPC male connector	1/8" × 1/4"LePure silicone tubing (15 cm)+ needleless sampling port	4" feeding port + clamp blind plate PH×2 Temperature electrode
	MG200-15K	200 L
	MG500-15K	500 L
	MG1000-15K	1000 L
	MG2000-15K	2000 L	1" × 11/8" LePure silicone tubing (150 cm)+ CPC female connector	1" × 11/8" LePure silicone tubing (150 cm)+ CPC male connector
	MG3000-15K	3000 L

STM series

Product line	Product code	Volume	Inlet tubing configuration	Outlet line configuration	Sampling line configuration	Process interface configuration
Standard model	STM001-4K	1 L	1/4" × 3/8"LePure silicone tubing (50 cm) +CPC female connector	1/4" × 3/8"LePure silicone tubing (50 cm) +CPC male connector	/	1.5" Feeding port+ clamp blind plate
	STM002-4K	2 L
	STM005-4K	5 L	3/8" × 5/8" LePure silicone tubing (50 cm)+CPC female connector	3/8" ×5/8" LePure silicone tubing (100 cm)+CPC male connector	1/8" × 1/4" LePure silicone tube (15 cm)+ needleless sampling port	1.5" feeding port+ clamp blind plate
	STM010-4K	10 L
	STM020-4K	20 L
Universal model	STM001-2K	1 L	1/4" × 3/8" LePure silicone tubing (50 cm)+TC50+ clamp blind plate		/	1.5" feeding port+ clamp blind plate
	STM002-2K	2 L			1/4" × 3/8"LePure silicone tube (20 cm)+ needleless sampling port
	STM005-2K	5 L	3/8" × 5/8" LePure silicone tubing (50 cm)+TC50+ clamp blind plate			3" feeding port + clamp blind plate
	STM010-2K	10 L
	STM020-2K	20 L
	STM030-2K	30 L
High-end model	STM005-3K	5 L	1/2" × 3/4"LePure silicone tubing (50 cm)+CPC female connector	1/2" × 3/4"LePure silicone tubing (100 cm)+CPC male connector	1/8" × 1/4"LePure silicone tube (15 cm)+ needleless sampling port	1.5" feeding port + clamp blind plate
	STM010-3K	10 L				1.5" feeding port + clamp blind plate PH×2
	STM020-3K	20 L

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LePure

LeKrius® Single-Use Mixing Bag

Description

Technical Parameters

Technical Parameters

Ordering Information

Ordering Information

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LeKrius^® Single-Use Mixing Bag