ASI Encompasses the Complete Single-Use System

BPI Contributor

July 1, 2009

2 Min Read


Advanced Scientifics is a leader in the design and manufacturing of single-use systems for the pharmaceutical and biotechnology industries. The company offers a multitude of solutions for flexible containers. Numerous films are available such as polyethylene (PE) and ethyl vinyl acetate (EVA) bags, as well as C-Flex, Silicone, PVC, and PharMed BPT tubing types. With sizes ranging from 50 mL to 2,500 L, Advanced Scientifics can produce single-use containers of nearly any configuration as well as multiple porting options with 700+ components in-house to choose from. Advanced Scientifics also has the capability to produce 3-D bags from 20 L and up, specific to customer specifications and tote dimensions.

Safest Downstream Tubing Sets

Advanced Scientifics offers a wide assortment of transfer and filtration sets for most any application. Our sets are used throughout the cell culture process, from media or buffer transfer to seeding or harvest — to separation and purification — to final packaging. Advanced Scientifics offers more than 80 different tubing sizes and types, as well as more than 900 off-the-shelf connectors. We use all Class VI materials in the fabrication and assembly of our 900+ connectors and 80+ tubing types and sizes.

Quality Process and Inspection

Advanced Scientifics’ quality management system is intertwined with its manufacturing system through the use of Advanced Scientifics’ enterprise resource planning (ERP) software called “Made 2 Manage.” This is an easy-to-use, high-quality ERP software that improves operational efficiencies, customer satisfaction, and financial performance. The item master, product print, routing, and bill of materials are all controlled by revision level within Made 2 Manage. Also, Advanced Scientifics’ “E-Ordering System” uses barcoding for all raw materials, routings, and so on.

From incoming raw material inspection through the entire manufacturing process to the final finished product, Advanced Scientifics’ ERP and quality management system is one of the industry’s fastest and strongest, making the company a leader in quality manufacturing. Advanced Scientifics’ quality system is accessible throughout the facility, giving all personnel access to quality files such as SOPs, STMs, SWPs, quality and employee manuals, and so on.

Specialized Product Delivery in 3–4 Weeks

After design, assembly, and packaging have been completed, Advanced Scientifics will further manage the sterilization of each single-use system. The company has validated this irradiation process to ensure that each product meets and exceeds the highest industry standards regarding sterility and validation, delivering a finished sterile product in three to four weeks.

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