With many years of experience designing manufacturing processes for bioabsorbable polymers for use in specialty injectables, you can count on us to seamlessly guide you through all the stages of development at the laboratory scale through scale-up of your operations and transfer to commercial manufacturing.
- Utilized QbD and risk-based assessment concepts to develop innovative polymer synthesis and purification processes, scale-up processes, and optimize current manufacturing processes.
- Supply specific project data to facilitate the budgeting process for the development, transfer, or implementation of technology.
- Train on client’s QMS & demonstrate GDP & cGMP practices in all process development, change control, and audit activities.
- Author, review, and execution of documentation to support equipment qualification for polymer manufacturing processes.
- Equipment URS,
- SOPs & Work Instructions
- IQ/OQ/PQ
- Author, review, and audit/revise development and validation studies/protocols/reports for new polymer synthesis processes.
- DoE for engineering studies to determine CPPs and CtQ attributes.
- Design and execution of engineering studies for process validation/verification.
- Author & execution of validation protocols and reports to qualify polymer manufacturing processes.
- Authored and reviewed technical documents to support regulatory submissions and technical transfers.
- Training of personnel on equipment, procedures, and manufacturing processes.
- Root cause analysis to aid in CAPA investigations and process optimization.
- Provide technical expertise and support for sustaining commercial manufacturing operations.
DIT Helicone Mixers
- System design and setup to meet your specific process needs.
- Develop unique cleaning solutions to meet your specific needs minimizing the amount of manual labor required.
- Author, review, and/or execution of documentation to support equipment qualification.
- Equipment URS
- SOPs & Work Instructions
- IQ/OQ/PQ protocols & reports
- Author, review, and audit/revise development and validation studies/protocols/reports for new polymer synthesis processes.
- DoE for engineering studies to determine CPPs and CtQ attributes.
- Design and execution of engineering studies for process validation/verification.
- Author & execution of validation protocols and reports to qualify polymer manufacturing processes.
- Author & execution of cleaning protocols and reports to qualify polymer manufacturing processes
- Training of personnel on equipment, procedures, and manufacturing processes.
- Trouble-shooting process/equipment issues and providing robust solutions to prevent future noncomformances or deviations.
- Provide technical expertise and support for sustaining commercial manufacturing operations