With the rapid development of the global biopharmaceutical industry, single-use bioprocessing is increasingly being widely applied. Compared to traditional bioprocessing, single-use bioprocessing has many advantages, including simpler operation, more flexible production planning, higher equipment utilization, and reduced risk of cross-contamination. These advantages have also made single-use bioprocessing solutions increasingly popular among industry players.
As a core provider of biopharmaceutical solutions, Bio-Link offers comprehensive single-use bioprocessing solutions to meet various process requirements, ranging from large-scale single-use bioreactors for cell culture to single-use fluid management consumables. Bio-Link's single-use products are impeccable in terms of product quality, compliance, pricing, and delivery. If you are looking for a reliable and long-term partner for single-use consumables supply, Bio-Link is undoubtedly your best choice.
Fully self-operated single-use consumables factory with 100% quality control.
Ample annual production capacity ensures timely delivery.
Bio-Link's disposable consumables production base is located in Nantong, Jiangsu Province, China. The factory covers a total area of over 27,000 square meters and has a total investment of 200 million RMB (approximately 31 million USD). The annual total production capacity of the disposable consumables factory is planned to be 2 million sets of disposable bioprocess consumables and 10 million sets of matching injection molded parts, with nearly 300 employees. The already operational Phase I, II, and III disposable consumables production workshops have a total area of 7,360 square meters and have passed the dual certification of ISO9001:2015 and ISO13485:2016 quality management system. The hardware equipment production workshop in Phase IV includes a 2,150 square meter sheet metal factory and a 1,400 square meter mold workshop. The main products/services workshop for Phase V expansion is focused on hydration products, with an expected annual production capacity of 5 million liters. In addition, we will also provide delivery, validation, and other services for our customers.
Bio-Link's disposable consumables are made from reliable raw materials. The films used in the BioHub® series bags are sourced from Renolit, a top global film supplier. The specialized biopharmaceutical films use advanced multi-layer co-extrusion technology and undergo thorough material quality certification, with validation documents provided. Their physical and chemical strength, gamma radiation tolerance, extractables level, and biocompatibility all meet the strictest standards in the biopharmaceutical industry.
Similar materials of construction, extremely low level of extractables and leachables;
High barrier property, optimizing the stability of products in the bag;
High transparency, easy to observe the status of products in the bag;
Animal-derived component-free (ADCF) materials, ensuring safety.
Bio-Link bioprocessing products are of exceptional quality and fully compliant. We make every effort to minimize the risk of quality and compliance issues for our customers. For our disposable consumables, the film materials used by Bio-Link have comprehensive quality control and traceability measures in place.
ISO 10993-4 Hemolysis
USP<87> Liquid contact material passed the cytotoxicity test,
USP<88> Liquid contact material passed the systemic acute toxicity test, intracutaneous test, and intramuscular implantation test
USP<661> plastic packaging system test
USP <85> Bacterial Endotoxins-LAL test
USP <88> Biological reactivity testing, in vivo, class VI
USP <661> Pharmacopoeia tests.
In addition, Bio-Link has a team of validation experts to ensure product quality. Our engineers are also available to support any verification and testing needs you may have.