Production

RiteDose Efficiency innovation generates up to 25% increase in CDMO production capacity


Engineering for the development of overvoltages

Columbia, South Carolina, Aug 03, 2021 (GLOBE NEWSWIRE) – RiteDose Corporation, the company born from the inventors of Blow-Fill-Seal (BFS) technology, has implemented engineering innovations that will now enable the development of The country’s leading BFS and Manufacturing Organization (CDMO) contracts to increase its production capacity by up to 25% compared to industry standards.

Innovations applied to RiteDose’s production lines in Columbia, South Carolina, will enable the company to meet ever-increasing demands and accelerate time to market for pharmaceutical companies developing new product lines.

“Innovation is at the heart of The RiteDose Corporation,” says Jody Chastain, CEO of RiteDose. “Our engineers have made significant changes to our methodology and production processes, which will allow us to increase production capacity up to 200 million units per year, well beyond the standard outputs of the industry. This latest innovation brings our BFS capacity to over 2 billion units per year.

The innovations are part of a $ 20 million capital avoidance strategy the company has implemented to create the ultimate flexibility in its production capacity and capabilities, making it the maker of BFS CDMO the most effective in the United States.

RiteDose Corporation has been a leading CDMO in the BFS field since the late 1990s when the company, then known as Holopack International, first received FDA approval for manufacture and distribution. pharmaceutical products.

“RiteDose has been an invaluable partner in developing robust manufacturing processes and in successfully expanding manufacturing to support our innovative drug pipeline,” said Vijay Sabesan of pharmaceutical developer Theravance Biopharma. “In addition to the vast expertise in manufacturing BFS, we greatly appreciate their flexibility and collaborative approach. “

Amid the COVID-19 pandemic, The RiteDose Corporation has expanded its operations to include a new 503B outsourcing facility to deliver sterile injectables to healthcare facilities across the United States. With over 25 years of cGMP experience in the production of sterile drugs for inhalation and ophthalmology, using this knowledge to help reduce drug shortages was the next logical step.

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What is blow-fill-seal and why is it the gold standard?

Blow-Fill-Seal is the benchmark in aseptic fill finish technology that uses low density polyethylene (LDPE) which is processed in five stages:

  1. A medical grade plastic resin is melted in an extruder and extruded through a nozzle and blown with sterile air to form a tube called a parison.

  2. This parison is then blow molded into a container shape in a multi-part mold.

  3. Then the containers are filled with a formulation.

  4. Finally, the molds seal the container. All actions take place inside a class 100 fill area.

  5. The product is then unloaded into a non-sterile area for further processing, including leak detection, packaging and distribution.

Find out how the process works at: https://www.rommelag.com/en/engineering/bfs/

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CONTACT: Dave Wilson The RiteDose Corporation [email protected]


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