New Manufacturing Facility

Project Outline:

• The CSIRO was contracted by the client to develop a novel synthesis for the manufacture of an inhaled pharmaceutical treatment. A bench scale process was developed that produced product that exceeded all the requirements of the United States Pharmacopoeia.
• Synertec was contracted by the client to work with CSIRO during this phase primarily as an advisor for the development of the process to ensure that what was being undertaken on the bench could be scaled up to a commercial process with minimal safety and regulatory hurdles.
• Once the basis for the process had been established, Synertec undertook a detailed Front End Engineering Design (FEED) exercise. The exercise involved investigating all the issues surrounding the design, construction, validation and operation of a pharmaceutical manufacturing facility.
• Synertec was contracted to deliver the project on a Lump Sum Turn Key (LSTK) basis. This included all aspects typical of a construction project but additionally required an extensive consultation process with local residents including community meetings and information sessions
• Refined and upscaled the manufacturing process.
• Designed and built the GMP manufacturing facility.
• Wrote all control and data acquisition software to GMP and 21CFR Part 11 requirements.
• Conducted supplier audits.
• Wrote all facility SOP’s and Batch Process Sheets.
• Qualified all process equipment.
• Validated the manufacturing process.
• Responsible for gaining TGA GMP licence.
• Registered the product on behalf of the client.
• On going manufacturing support.

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