Process Development
Knowledge and Experience
Qualifications
Design, Installation, Commissioning, Validation and Qualification (DQ, IQ, OQ, OQ).
Process Optimisation
Process optimization due to raw material changes, improvements in process conditions
SOPs and Trainings
Generating S.O.P. and training for use of processes and internal workflows
Quality Controls
Development and management of QA / QC controls in processes and equipments
With You. For You..
Process development investigations should provide the basis for process improvement, process validation, continuous verification, and any process control requirements. Depending on the level of experience within the organization, overall process development efforts and timelines can vary tremendously.
While the upstream team is already working on a new process version, the downstream team is still developing a process for material from the previous upstream process iteration.
Development of process steps may occur without sufficient awareness of the existing operation limits and the capability of large-scale equipment in manufacturing. Therefore, an early awareness of the final scale of manufacturing and its potential constraints is essential for successful process design. Intran does just that
We Perfect The Development..
Over the years we have done projects that cover various scales, objective and mandates, including:
- Data on process parameters is analyzed for scale up to pilot and production capacities to meet client’s requirements. This will include systems sizing and integration as well as automation to fit client’s budget. Hence, an integral part of this exercise includes feasibility studies.
- Liaison with authorities to meet local requirements such utilities, occupational health & safety related matters, environmental impact issues and fire department services.
Client References
- Sime Darby Tech. Centre (Enzymatic Reaction Process & Facility)
- Malaysia Palm Oil Board (Recovery & Purification of Oil Palm Phenolics)
- Ryufu Food Technology (M) Sdn Bhd (Extraction & Processing of Tea)
Network and Expertise
ITSB has extensive expertise and network in GMP/GTP compliant processes.
Experience
20+ successfully executed projects involving Bio-reactors, Bio-processing and Stem Cell R&D
Advisory and Execution
We don't just provide drawing room consultancy - we are on the site, building for (or with) you