Engineering for Surge Development
Columbia, SC – The RiteDose Corporation, the company born from the inventors of Blow-Fill-Seal (BFS) technology, has implemented engineering innovations that will now allow the country’s leading BFS Contract Development and Manufacturing Organization (CDMO) to increase its production capacity by up to 25% over industry standards.
The innovations applied to RiteDose’s production lines in Columbia, South Carolina will allow the company to meet ever-increasing surge demands and bring faster time-to-market efficiencies for pharmaceutical companies developing new product lines.
“Innovation is at the heart of The RiteDose Corporation,” says RiteDose CEO Jody Chastain. “Our engineers have made significant changes in our production methodology and processes that will allow us to increase production capacity by up to 200 million units per year – substantially beyond standard industry outputs. This latest innovation pushes our BFS capacity to more than 2 billion units annually.”
The innovations are part of a $20 million capital avoidance strategy that the company has implemented to create the ultimate flexibility in its production capacity and capability, making it the most efficient BFS CDMO manufacturer in the United States.
The RiteDose Corporation has been a leading CDMO in the BFS arena since the late 1990s when the company, then known as Holopack International, first received FDA approval for manufacturing & distributing drug products.
“RiteDose has been an invaluable partner in developing robust manufacturing processes and successfully scaling up manufacturing to support our pipeline of innovative drugs,” says Vijay Sabesan of pharmaceutical developer Theravance Biopharma. “In addition to the extensive expertise in BFS manufacturing, we greatly value their flexibility and collaborative approach.”
In the midst of the COVID-19 pandemic, The RiteDose Corporation expanded its operations to include a new 503B Outsourcing Facility to supply sterile injectable products to healthcare facilities across the United States. With over 25 years of cGMP experience producing sterile drugs for inhalation and ophthalmology, utilizing this knowledge to help ease drug shortages, was the next logical step.
What is Blow-Fill-Seal & How Is It the Gold Standard?
Blow-Fill-Seal is the gold standard in aseptic fill finish technology that uses a low density polyethene (LDPE) that is processed in a five-stage operation:
- A medical-grade plastic resin is molten in an extruder and extruded through a nozzle and blown with sterile air to form a tube called parison.
- This parison is then blow molded into the container-shape within a multi-part mold
- Thereafter, the containers are filled with a formulation.
- Finally, the molds seals the container. All actions take place inside a Class 100 filling zone.
- The product is then discharged to a non-sterile area for further processing, to include leak detection, packaging, and distribution.
See how the process works at : https://www.rommelag.com/en/engineering/bfs/