Software & Control
Automation is a key factor for achieving a high-efficiency production floor performance.
Biopharmax has over 25 years of experience in this field, with an experienced team of software and control engineers with vast experience in the Biotech and Pharmaceutical Industries.
The programming process is done according to SDLC (Software Development Life Cycle) starting from the design stage, including:
- Hardware and software design documents
- FDS (functional Design Structure)
- Software programming according to S88
- Simulation
- Commissioning
- Validation (CSV and process validation)
- Comply with CFR Part 11
- Data Integrity
- Data analysis
- IOT
Biopharmax is experienced with creating fully automated systems such as Process, CIP/SIP, HVAC, PW/WFI, RO, Ultra filtration systems, and BMS.
We strive for a high level of automation to ensure:
- Batch to batch repeatability and minimize rejected batches
- Improve process control resulting in increased product yield
- Reducing the human factor to improve facility safety
- Multi-product manufacturing/formulation/filling by utilizing a recipe program
- Future expansion support for complete plant integration
- Process monitoring in compliance with QA and validation requirements
