Located in Nantong City, Jiangsu Province, with a total area of about 27,000 square metres, the production base of Bio-Link's single-use consumables has a planned total annual capacity of 2 million sets of single-use process consumables and has been certified with the dual quality management system certifications of ISO9001:2015 and ISO13485:2016.
The BioHub® series of single-use mixing bags can be flexibly matched with different types of stirring paddles, and can also satisfy a variety of mixing forms, such as magnetic coupling or magnetic levitation, which are compatible with all kinds of hardware equipment in the market.
BioHub® single-use bags are available in a wide range of membranes to cover the entire life cycle of biopharmaceuticals, depending on the customer's usage scenario and the bag's functionality.
Single-use storage bag is widely used in biopharmaceutical process because of its convenient and simple operation. By integrating a wide range of different components into a single-use system, Bio-Link maximizes the operation of the pharmaceutical process. The BioHub® series of single-use storage bag includes 2D storage bags and 3D storage bags, which can be used for product weighing transfer and open dispensing, to meet the storage and transfer needs of various liquids in different volumes.
BioHub® 2D bags are made of co-extruded multilayer film with boat-shaped welded outlets to minimise residual liquid volume, and are available in 1/8", 1/4", 3/8" and 1/2" ports for silicone and thermoplastic tubing. The BioHub® 3D storage bags are available in round and square shapes, which can be used in a wide range of equipment for different customers.
The size of the bag body ranges from 5mL-3000L, and the volume can meet different needs.
Have a professional process team to support product configuration and design and flexible customization;
The new angle design of welding edge reduces the residue of material liquids.
Scope of Application:
Filtration and storage of buffers and culture medium.
Harvest of raw liquid; sample collection.
Preservation of intermediate products, transportation of the final product.
The stirring paddles of BioHub® series single-use mixing bags adopt the process of high strength magnet secondary coating, and the whole magnet package is guaranteed to be completely sealed; different mixing blades are used for efficient mixing. Mixing bag body design is flexible and can integrate various types of sensors to achieve online pH, conductance and temperature monitoring; It can also be flexibly equipped with a variety of sizes of feeding ports to meet the needs of solid feeding.
The blades of the BioHub® series single-use mixing bags are rigorously tested: after 48 hours of high speed operation, samples are taken for insoluble particles and no visible foreign objects are observed in the bags. After many experimental tests, the insoluble particles produced by the bag body were in line with the Chinese Pharmacopoeia, and far below the standard, and no visible foreign matters were produced.
In addition, the mixing bag can be used with Bio-Link's desktop mixer. Bio-Link's self-developed stirring paddles design enables the dynamic minimum mixing volume as low as 200mL to meet the mixing needs of smaller volumes of precious material liquids.
The volume range is 2L-3000L, which can meet the different needs of R&D, pilot test and commercialization.
Widely suitable for mixing systems on the market;
Support 100% flexible customization, fit customer needs;
Complete documentation of mixing efficiency.
Scope of Application:
Preparation of buffers and media;
Preparation of intermediate and semi-finished products;
Virus inactivation; blending of vaccine adjuvants.
All-round advantages, "Mixing" more assured
In order to ensure product quality, after the BioHub® series single-use process bag body and pipeline are assembled, 100% integrity test is performed (with the self-developed integrity tester, which can detect a minimum of 30μm aperture defects) to ensure that there is no overall risk of leakage, giving customers peace of mind.
After sterilization by 50±5kGy irradiation, the nominal volume of purified water was injected into the bag body, and the pressure was maintained at a constant speed until 5kPa for 72 hours, during which the bag body was observed for damage or leakage. The test results show that there is no damage or leakage of the bag body under the test conditions, and the integrity of the bag body is good.
The BioHub® series single-use process bag was sterilized by 50±5kGy irradiation, then water was added to 110% of the nominal volume at room temperature, the liquid-stopping clip was closed, and the integrity of the bag was observed during not less than 7 days. The test results show that the appearance of the single-use liquid storage system has not changed significantly after no less than 7 days of liquid loading test, and the integrity of the bag body is good.
BioHub® series single-use process bags were tested for endotoxin in the leachate at a ratio of 6:1 cm2/mL of sample surface area to extraction medium, according to the Dynamic Colorimetric Method of Photometric Determination in Chinese Pharmacopoeia (2020 Edition)<1143> (same as USP<85>), and the data results show that the endotoxin content of the leachate of the BioHub® series single-use process bag under the nominal volume is less than 0.25EU/mL, which meets the endotoxin limit for water for injection. Endotoxin tests are performed on the center control products every day in production, and the products will be released only if the endotoxin meets the standard. In addition, Bio-Link conducts insoluble particles tests every day in its daily production, and will only release the products if the insoluble particles meet the standards.
Bio-Link single-use process bags were dynamically extracted under extreme conditions of 40°C using the extreme test conditions for extractables recommended by BPOG & USP<665>, i.e., solvent conditions of 50% ethanol, water, 0.1M phosphoric acid, pH 3.0 buffer, 0.5N sodium hydroxide, and buffer of pH 10.0 were selected. LC-DAD-QTOF, HS-GCMS, DI-GCMS, and ICP-MS were used to detect the organics in the extracts, and the study covered all the categories of additives for prudent use involved in the Technical Guidelines for the Study of the Compatibility of Chemicals and Elastomer Seals (Trial), with 18 commonly used antioxidants and their degradation products that may be introduced by the materials, 24 plasticizers, 6 anilines, 8 nitrobenzenes, 32 alkanes and more than 80 volatile substances.
The test results show that the extractable levels are all within the PDE (daily exposable dose) range of the compounds, with good extractable levels and product safety.