LeKrius^® Single-Use Bioprocess Storage 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

Adopts in-house developed LeKrius^® bioprocess film, 400 μm reinforced, Irgafos^® 168-free. Film with filed DMF; product fully compliant with USP, EP, ISO and ASTM standards
Raw materials and manufacturing processes TSE/BSE-free.
2D and 3D biocontainers available
Specification: 5 mL–4000 L
Various tubing and fittings optional
Customizable features: temperature, conductivity, sampling, etc

Advantages

Excellent batch-to-batch consistency with reliable supply
Strict particulate control
100 % Integrity Tested
Full-size coverage, high process compatibility
Fully customizable for tailored processes

Applications

Upstream Cell Culture

Storage of culture media and buffers
Hold and transfer of seeds and feeds
Collection, hold and transfer of cell harvest
Harvest collection, hold and transfer

Downstream Purification

Collection and hold of target molecules
Storage of buffers, acids and bases
Hold and inter-step transfer of process intermediates

Drug Substance & Formulation

Harvest, storage and transfer of drug substance
Hold of formulation intermediates
Pre-filling buffer bag

Technical Parameters

Basic Physical Parameters

Test items	Applicable Standard	Test Results
Film Composition	Internal Enterprise Specification	Multi-layer co-extruded polymer (LDPE/EVOH/ULDPE)
Film Thickness (μm)	ASTM D6988	400
Light Transmittance (%)	ASTM D1003	87
Haze (%)	ASTM D1003	42
Tensile Strength at Break (MPa)	ASTM D882	14
Elongation at Break (%)	ASTM D882	432
Density (g/cm)	ASTM D792	0.9
Water Vapor Transmission Rate(g/m2·day)	ISO 15106-2/ASTM F1249	0.8
Oxygen Transmission Rate(cm3/m2·day·bar)	ASTM D1434/ASTM D3985	1.1
Carbon Dioxide Transmission Rate (cm3/m2·day·bar)	ASTM D1434/ASTM F2476	0.8
Puncture Strength (N)	ASTM F1306/ASTM F392B	50.1
Flex Resistance (Cycles)	ASTM D6988	≥5000

Mechanical Performance Verification

Test items	Applicable Standard	Test Results
Film Thickness Uniformity Test	ASTM D6988	Compliant
Machine Direction (MD) Tensile Strength	ASTM D882	Compliant
Transverse Direction (TD) Tensile Strength	ASTM D882	Compliant
Film Puncture Strength	ASTM F1306	Compliant
Dart Drop Impact Strength	ASTM D1709	Compliant
Heat Seal Strength	ASTM F88	Compliant

Cleanliness and Performance Testing

Test items	Applicable Standard	Test Results
Particulate Matter Test	USP <788>	Compliant
Bacterial Endotoxin Test	USP <85>	Compliant
Visible Particulates Test	USP <790>	Compliant
Bag Integrity Test	ASTM F2095-07(21)	Compliant
Total Organic Carbon (TOC) Test	USP <643>	Compliant
Conductivity Test	USP <645>	Compliant

Biocompatibility and Material Compliance

Test items	Applicable Standard	Test Results
In Vitro Biological Reactivity Test	USP <87>	Compliant
In Vivo Biological Reactivity Test (Class Ⅵ)	USP <88> Class Ⅵ	Compliant
Physicochemical Testing for Pharmaceutical Plastics	USP <661>	Compliant
Hemolysis Test/Cytotoxicity/Sensitization Test	ISO 10993 Series	Compliant
TSE/BSE Risk Assessment	EP 5.2.8	Compliant

Ordering Information

2D Storage Bag (LeFlex® TPE Tubing + Terminal Luer Fitting) – General

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
HP0050-1AK	50 mL	1/8"×1/4" LeFlex® TPE tubing,30 cm + female Luer fitting	1/8"×1/4" LeFlex® TPE tubing,30 cm + male Luer fitting	/
HP0100-1AK	100 mL

2D Storage Bag (LeFlex® TPE Tubing + Terminal Luer Fitting) – General

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
HP0250-3AK	250 mL	1/4"×3/8" LeFlex® TPE tubing, 30 cm + female MPC connector	1/4"×3/8" LeFlex® TPE tubing,30 cm + male MPC connector	/
HP0500-3AK	500 mL
HP001-4AK	1 L	1/4"×3/8" LeFlex® TPE tubing, 50 cm + female MPC connector	1/4"×3/8" LeFlex® TPE tubing,50 cm + male MPC connector	1/4"×3/8" LePure silicone tubing, 20cm + needleless sampling port
HP002-4AK	2 L
HP003-4AK	3 L

2D Storage Bag (LeFlex® TPE Tubing + Terminal CPC Connector) – General

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
HP005-5AK	5 L	3/8"×5/8" LeFlex® TPE tubing, 50 cm + female MPC connector	3/8"×5/8" LeFlex® TPE tubing,50 cm + male MPC connector	1/4"×3/8" LePure silicone tubing, 20cm + needleless sampling port
HP010-5AK	10 L
HP020-5AK	20 L
HP030-5AK	30 L
HP050-5AK	50 L

2D Storage Bag (LeFlex® TPE Tubing + Terminal Tube Plug) – Upstream

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
HP001-5DK	1 L	3/8"×5/8" LeFlex® TPE tubing,60 cm + tube plug	3/8"×5/8" LeFlex® TPE tubing,60 cm + tube plug	1/4"×3/8" LeFlex®TPE tubing, 20 cm+ needleless sampling port
HP002-5DK	2 L
HP005-5DK	5 L
HP010-5DK	10 L
HP020-5DK	20 L
HP050-5DK	50 L

2D Storage Bag (Inlet Filter, 550 cm²) – Upstream

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
HP001-5BK	1 L	3/8"×5/8" LeFlex® TPE tubing, 50 cm + filter(P1S5DS5THM) + 3/8"×5/8" LePure silicone tubing, 30cm + female MPC connector	3/8"×5/8" LeFlex® TPE tubing,50 cm + tube plug	1/4"×3/8" LeFlex®TPE tubing, 20 cm+ needleless sampling port
HP002-5BK	2 L
HP005-5BK	5 L
HP010-5BK	10 L
HP020-5BK	20 L
HP050-5BK	50 L

2D Storage Bag (LePure Silicone Tubing + Terminal CPC Connector) – Downstream

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
HP001-5EK	1 L	3/8"×5/8" LePure silicone tubing, 50 cm + female MPC connector	3/8"×5/8" LePure silicone tubing, 50 cm + female MPC connector	1/4"×3/8" LePure silicone tubing, 15cm + Luer sampling port
HP002-5EK	2 L
HP005-5EK	5 L
HP010-5EK	10 L
HP020-5EK	20 L
HP050-5EK	50 L

2D Storage Bag (Inlet Filter, 550 cm²) – Downstream

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
HP001-5CK	1 L	3/8"×5/8" LePure silicone tubing, 50 cm (with breakaway ring) + filter (P1S5DS5THM) +3/8"×5/8" LePure silicone tubing, 30 cm + female MPC connector	3/8"×5/8" LePure silicone tubing, 50 cm + TC25 +clamp blind plate	1/4"×3/8" LePure silicone tubing, 20cm + Luer sampling port
HP002-5CK	2 L
HP005-5CK	5 L
HP010-5CK	10 L
HP020-5CK	20 L
HP050-5CK	50 L

2.5D Storage Bag (Terminal TC50 + Clamp Blind Plate) – General

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
FT057-7K	57 L	3/8"×5/8" LePure silicone tubing,150 cm + TC50 +clamp blind plate	3/8"×5/8" LePure silicone tubing, 50 cm + TC25 +clamp blind plate	1/8"×1/4" LePure silicone tubing, 30cm + needleless sampling port
FT113-7K	113 L
FT208-7K	208 L
FT303-7K	303 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
FT378-7K	378 L

2.5D Storage Bag (Terminal CPC Quick Connector) – General

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
FT057-8K	57 L	3/8"×5/8" LeFlex® TPE tubing, 150 cm + male MPC connector	3/8"×5/8"LeFlex® TPE tubing, 150 cm + male MPC connector	1/8"×1/4" LePure silicone tubing, 30cm + needleless sampling port
FT113-8K	113 L
FT208-8K	208 L
FT303-8K	303 L	1/2"×3/4" LeFlex® TPE tubing, 150 cm + male MPX connector	1/2"×3/4"LeFlex® TPE tubing, 150 cm + male MPX connector
FT378-8K	378 L

3D Storage Bag (Terminal TC50 + Clamp Blind Plate) – General

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
FD250-7K	250 L	3/8"×5/8" LePure silicone tubing, 150 cm + TC50 +clamp blind plate	3/8"×5/8" LePure silicone tubing, 150 cm + TC50 +clamp blind plate	1/8"×1/4" LePure silicone tubing, 30cm + needleless sampling port
FD500-7K	500 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
FD1000-7K	1000 L

3D Storage Bag (Terminal CPC Quick Connector) – General

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
FD250-8K	250 L	3/8"×5/8" LePure silicone tubing, 150 cm + male MPC connector	3/8"×5/8" LePure silicone tubing, 150 cm + male MPC connector	1/8"×1/4" LePure silicone tubing, 30cm + needleless sampling port
FD500-8K	500 L
FD1000-8K	1000 L

3D Storage Bag (Terminal Tube Plug) – Upstream

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
FD100-11K	100 L	1/2"×3/4" LeFlex® TPE tubing, 60 cm + tube plug	1/2"×3/4" LePure silicone tubing, 50 cm + 1/2"×3/4"LeFlex® TPE tubing, 60 cm +tube plug	1/4"×3/8" LePure silicone tubing, 6cm + 1/8"×1/4"LeFlex® TPE tubing, 20 cm +needleless sampling port
FD200-11K	200 L
FD250-11K	250 L
FD500-11K	500 L	1/2"×3/4" LePure silicone tubing, 100 cm + 1/2"×3/4" LeFlex® TPE tubing, 60 cm +tube plug	1/2"×3/4" LePure silicone tubing, 100 cm + 1/2"×3/4"LeFlex® TPE tubing, 60 cm +tube plug
FD1000-11K	1000 L

3D Storage Bag (Inlet Filter) – Upstream

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
FD100-9K	100 L	1/2"×3/4" LeFlex® TPE tubing, 100 cm + filter (P1S5D05THM) + 1/2"×3/4"LePure silicone tubing, 50 cm + female MPX connector	1/2"×3/4" LePure silicone tubing, 100 cm + 1/2"×3/4"LeFlex® TPE tubing, 50 cm+ tube plug	1/4"×3/8" LePure silicone tubing, 6cm + 1/8"×1/4"LeFlex® TPE tubing, 20 cm +needleless sampling port
FD200-9K	200 L
FD250-9K	250 L
FD500-9K	500 L	1/2"×3/4" LeFlex® TPE tubing, 100 cm + filter (P1S5D20TBM) + 1/2"×3/4"LePure silicone tubing, 50 cm + female MPX connector
FD1000-9K	1000 L

3D Storage Bag (Inlet CPC, Outlet TC25) – Downstream

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
FD100-12K	100 L	1/2"×3/4" LePure silicone tubing, 150 cm + female MPX connector	1/2"×3/4" LePure silicone tubing, 150 cm + TC25 +clamp blind plate	1/8"×1/4" LePure silicone tubing, 15cm + Luer sampling port
FD200-12K	200 L
FD250-12K	250 L
FD500-12K	500 L
FD1000-12K	1000 L

3D Storage Bag (Inlet Filter) – Downstream

Product Code	Volume	Inlet Tubing	Outlet Tubing	Sampling Tubing
FD100-10K	100 L	1/2"×3/4" LePure silicone tubing, 50 cm (with breakaway ring) + filter (P1S5D04THM) + 1/2"×3/4"LePure silicone tubing, 100cm + female MPX connector	3/8"×5/8" LePure silicone tubing, 150 cm + TC25 +clamp blind plate	1/8"×1/4" LePure silicone tubing, 15cm + Luer sampling port
FD200-10K	200 L
FD250-10K	250 L
FD250-10K	500 L	1/2"×3/4" LePure silicone tubing, 50 cm (with breakaway ring) + filter (P1S5D10THM) + 1/2"×3/4"LePure silicone tubing, 100cm + female MPX connector	1/2"×3/4" LePure silicone tubing, 150 cm + TC50 +clamp blind plate
FD1000-10K	1000 L

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LePure

LeKrius® Single-Use Bioprocess Storage Bag

Description

Technical Parameters

Technical Parameters

Ordering Information

Ordering Information

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LeKrius^® Single-Use Bioprocess Storage Bag