Paslanmaz çelik işlenmesindeki tecrübemiz ve tutkumuz ayrıntılardaki kaliteyle ilgilenmemize yardımcı olmaktadır. Enerji tasarrufu, hijyen kalitesi ve tüm malzemelerin ve komponentlerin sertifikasyonları ve uzun dönem güvenilirlik bizim ekipmanlarımız için kesin kurallardır.
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 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. 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 And Bioreactors
Cip/Sip Systems
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.
BRAM-COR manufactures bags linear filling equipment. BFIL according to cGMP regulations. The equipment is completely validable with all parts in contact with the fluids in AISI 316L
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BRAM-COR Cleaning in Place / Sterilizing in Place systems are designed to fully meet cGMPs requirements in cleaning and sterilizing practices commonly applied in pharmaceutical process lines.
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BRAM-COR Pure Steam Generators Mod. CPSG produce dry, saturated steam, suitable for sterilization of pharmaceutical production plants, for direct contact with API, ...
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CROS Sanitary Reverse Osmosis Systems are designed to produce compendial purified (PW) and higly purified (HPW) water through several water treatment steps,
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BRAM-COR offers a complete range of preparation lines suitable for any pharmaceutical formulation: reactor vessels, pressure vessels, pressure tanks, mobile mixing vessels, customized formulation tanks,atmospheric transfer tanks.
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The BRAM-COR Single Effect Distiller Mod. DPSG is both a Still and a Pure Steam Generator. This equipment produces dry, saturated steam to be used as sterilizing agent.
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Double Tube Sheet Heat Exchangers BRAM-COR DTS are designed to maximize the efficency, while minimizing resistance to fluid flow through the exchanger thus increasing the performance.
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The FFIL pharmaceutical linear filling machine for bottles represents an evolution of filling for pharmaceutical rigid vessels, combining reliability, precision and low maintenance costs.
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According to specific product requirements (viscosity, temperature, oxygen sensitivity, aseptic issues etc.), BRAM-COR integrates his formulation plants
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BRAM-COR full-stainless steel OZONE GENERATORS Mod. GENO are conceived for pharmaceutical application, i.e. for water disinfection and loop sanitization.
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KOMB is a unique equipment for the simultaneous production of WFI and PS, combining the double functions of a MEDistiller and of a Pure Steam Generator
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BRAM-COR integrates its equipment with state-of-the-art distribution loops. Our Loop design is the result of a careful evaluation of Points of Use delivery criteria.
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Bram-Cor customized belt conveyors are designed to satisfy any requirement in the handling of pharmaceutical containers throughout the drug packaging process.
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BRAM-COR Water Pre-Treatment Systems Mod. PRTW are customized upon a careful evaluation of feed water quality using local water analysis.
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From equipment control to production line supervision, BRAM-COR SCADA systems (Supervisory Control And Data Acquisition) provide full management control throughout the plant lifecycle.
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BRAM-COR Multiple Effect Stills Mod. SMPT are designed and manufactured according to cGMP to produce compendial Water for Injection.
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Special sanitary components in AISI 316L fit pharmaceutical systems and industrial lines, such as 316L SS housings for water and air filters
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STMC Vapor Compression Distiller produces compendial distilled water for pharmaceutical applications (WFI), such as LVP, SVP,
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BRAM-COR range of products includes a complete range of pharmaceutical holding tanks for storing compendial.
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BRAM-COR produces the Uvitron line, a wide range of UV Reactors and Control Units offering advanced technical features.
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Particulate matter in parenteral solutions can be detected through BRAM-COR VIS Inspection systems with black/white background for human inspection.
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As a functional completion to our bottles filling lines, the Capping Machines of Bram-Cor ensure a full-automated sealing operation.
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