Customization in Single-Use

Success Stories > Customization in Single-Use

Challenge

Our customer partnered with us to design, prototype, and manufacture custom, single-use disposable bioprocessing bags in volumes ranging from 50 liters to 500 liters. Given that the drug manufacturing industry has not coalesced around one particular equipment standard, our customer wanted the ability to market a fully customizable single-use bioprocessing bag to support the needs of their clients. The bags needed to be produced in the controlled environment of an ISO Class 8 cleanroom. They also required the bags to arrive at their facility unsterilized so they could assemble them with fully customized tubing and filters before sterilizing and delivering to their end customer. 

We use the Agile Method for product development..

Solution

While generic bags are available, they wanted to have control over the location and types of ports for their branded bags. Incorporating customer feedback, our engineering team worked in an iterative fashion through the development process to optimize and streamline the construction of the bioprocess bags. Using industry best practices, we refined the process to scale to production quantities in an ISO Class 8 cleanroom. The finished bag design minimizes the number of pieces and seams, which provides a durable product when filled, all the while maximizing foldability to pack flat for shipping, reducing the risk of product damage in transit.

The bioprocessing bags were manufactured with an industry-standard film specified by our customer. To ensure quality, we used our in-house testing equipment to perform range studies on weld strength; to validate the optimal seal temperature, pressure, and dwell time. Our engineering team designed a custom tooling fixture to test the flexible-to-rigid seal made by heat staking ports to the film. The ability to test in-house dramatically reduces time in the development feedback loop and allows us to hone in on the optimal settings and minimize cost. 

Boyd Technologies uses best in class product development technology solutions to help streamline the development cycle

Results

Boyd Technologies developed a custom line of single-use bioprocessing bags for a biotechnology, biopharmaceutical, and pharmaceutical equipment supplier. The types and locations of the various ports are specific to suit the needs of the end customer. We designed a complex 3-dimensional bag that also packs flat; fulfilling their design requirements. Using our in-house testing equipment, we quantified the weld strengths of both the flexible film-to-film and film-to-rigid seals. Our engineering development team then used industry best practices to move the product from process design, through process validation, to ultimately release the product to production in an ISO Class 8 cleanroom. 

Our Advantages

Boyd Technologies manages complexity for customers by offering turn-key solutions in material sourcing, product development, and advanced manufacturing of single-use disposables for life science and medical device fields. We provide solutions in:

  • Process mapping allowing for small-scale prototyping to high-throughput production
  • Custom test plans and in-house testing
  • Iterative problem-solving in product development
  • Creating custom validation programs 
  • Risk mitigation throughout the design process
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