Category: Project Drivers

BRAM-COR PROJECT DRIVERS

All Pharmaceutical Facilities need to be up-dated, competitive and efficient in operation, to diversify production programs, to reduce life-cycle costs and, above all, to comply to the appropriate pharmaceutical GMP regulation.

Bram-Cor project drivers are aimed at satisfying all pharmaceutical regulatory and QA requirements, aligning the final product to the international Pharmacopoeias and capitalizing upon a careful, customer-oriented project management.

Equipment and process flow are designed to allow a logical flow in order to avoid mix-ups of components, drug product, closures, labeling, in-process materials or cross contamination achieved through the  development of:

  • Conceptual Design describing the general project organization
  • Detailed Engineering, considering all process flows (raw materials, finished products, personnel, waste, etc.) and detailed project specifications

BRAM-COR QUALITY SYSTEM

Bram-Cor works following an ISO 9001:2008 certified quality system. Planning, monitoring, testing, identification and recording are baseline issues of our work, from system design to system validation. Continuous Q.A.S. improvement is pursued through a scrupulous assessment of any non-conformity, reflected in the steady revision of our working procedures. No one pharmaceutical critical system is really the same, each plant has different technical features. Achieving pharmaceutical quality at a good quality/price ratio whilst offering the highest customization is our goal: Bram-Cor ensures professional support throughout the system lifecycle, thanks to a rigorous teamwork.

Water for Injection – Multiple Effect Distillation systems

Every Bram-Cor SMPT – Multiple Effect Distiller is designed and manufactured according to cGMP and produced compendial Water for Injection. Each unit contains a number of boiling columns (or effects, stills) with the first column producing pure steam, which is condensed and re-distilled  in the following columns decreasing the operational costs. Heating for evaporation and cooling  for condensation processes are […]

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