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 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 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.
EXPERIENCE AND PASSION
Bram-Cor experience and passion for stainless steel processing enable us to care for quality in details. Energy saving concerns, sanitary quality and certifications of all materials and components, long-term reliability are a rule for our equipment. Each Bram-Cor equipment or line is manufactured following cGMP procedures. AISI 316L Stainless steel piping and AISI 304 frameworks are welded by qualified welders following Bram-Cor Sanitary Piping procedures. Certified sanitary fittings and components are assembled on the line, ensuring good access to all items for easy maintenance operation. Non-destructive tests are performed during construction.
Each component is identified by a unique TAG, engraved on metal plate, for total traceability in the relevant technical documentation. Functional testing is ensured by automation experts, with special care for monitoring of critical parameters. Documentation, inspection and field testing are included in our project management.
LONG TERM VALUABLE PARTNERSHIPS
Most our businesses is with long term Clients. A close partnership with our Customer is therefore the core of our work philosophy. The direct contact with the End User ensures full committment in any long term relationship.