BRAM-COR engineering team focuses mostly on fluid drugs sterile production processes. A full understanding of the drug production process is the key concept for correct design, born from almost 40 years of experience.
KEY DESIGN CONCEPTS
Clear definition, assessment, monitoring of critical parameters directly affecting product quality are the baseline for the application of suitable Process Analytical Technologies granting both complete in-line and at-line quality control. Every process follows rigorous cGMP-compliant Standard Operative Procedures. Specification, construction, verification steps within the project lifecycle follow GAMP “V” models, considering Risk Assessment, architecture of system components, functional specification, sanitization, sterilization and validation issues with special overview to a sustainable maintenance of the system. Our BRAM-COR work breakdown structure consisting in following activities:
- Design (quality by design)
- Construction (mechanicals, electro-pneumatics, software)
- Start up
BRAM-COR involves its proven experience in three ranges of pharmaceutical equipment: