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 50 years of experience. 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 Operating 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:
A complete technical documentation is part of our equipment and includes:
BRAM-COR involves its proven experience in three ranges of pharmaceutical equipment:
BRAM-COR pharmaceutical water treatment systems are designed to produce compendial
Pre-treatment options, monitoring of critical parameters, regulatory requirement for product quality, consumptions, microbiological control, operation and maintenance requirements, lifecycle costs are key points in our design of all processing steps, from feed water to the point of use. Special care is given to the choice of sanitary materials. Product-contact surfaces are in certified AISI 316L stainless steel, with standard roughness ≤ 0.4 µm. EPDM or PTFE gaskets ensure perfect sealing. Advanced Process Analytical Technologies are applied for monitoring issues and professional GAMP compliant automation is provided for system control.
BRAM-COR designs, manufactures and installs complete Formulation & Preparation Plants starting from specific Product and User Requirements. Sterile preparation or cleaning and sterilization of process vessels or contact equipment are common issues in the pharmaceutical industry and therefore a must in any of our projects.
Specific manufacturing of solutions or sanitization & sterilization requirements can be satisfied by our processing systems, providing the optimum balance of performance with cost effective aseptic processing equipment through BRAM-COR solutions including:
Mixing Tanks, Pressure Vessels and Bioreactors
Ancillary Systems For Formulation Lines
BRAM-COR pharmaceutical bags or bottles filling equipments are intended for automatic, semiautomatic or manual use, for different bags or plastic/glass bottle sizes, according to various production needs from min. 10 ml, smaller volumes on demand. Our equipments ensure trouble-free operation, with reduced maintenance costs and long-term reliability.
Complete bottle lines are integrated with washing machines, capping and crimping machines, labelling lines and belt conveyors.