• Bram-Cor Pharmaceutical Processing systems - Mobile mixers and dissolutor vessels

Equipment

Plants and systems for pharmaceutical manufacturing

BRAM-COR is focused mostly towards production processes and plants aimed at the manufacture of sterile liquid drugs. The principal behind our correct and exceptional designs is attributable to our extended knowledge of the production processes of such drugs, due to almost 50 years of experience in international settings and an excellent 100% made in Italy manufacture. 

The application of a suitable and complete analysis of our technologies begins in BRAM-COR from a clear definition: it includes a prompt evaluation and a careful monitoring of all the critical parameters that could directly influence the quality of the end-product. This way, we ensure a complete quality control, both within and between our production lines. Each process follows the rigorous requirements dictated by cGMP (current Good Manufacturing Practice), which have now been adopted as one of our work guidelines.

BRAM-COR plants are hence based on a detailed description of every possible constructive element and aspect, accompanied by processes of evaluation within the life cycle of each project, following the requirements “GAMP V” and constantly taking into account the evaluations of the risk of the structure, the system’s components, functional specifications, disinfection, sterilization, validation problems and the sustainable maintenance of the entire plant. 

BRAM-COR carries out the following activities: 

  • Design (quality of technical-industrial design)
  • Construction (mechanicals, electro-pneumatics, software)
  • Testing
  • Documentation
  • Installation
  • Validation
  • Start up

 A complete technical documentation is part of our equipment and includes:

  • General Documentation and Constructive Specification
  • Components Documentation
  • Valves Documentation
  • Instruments Documentation
  • Electrical/pneumatic Documentation
  • Hardware and Software Documentation
  • Piping, Fitting and Welding Documentation
  • Non-destructive test certificate
  • Operating and Maintenance Instructions 
  • Lists of Spare Parts  

BRAM-COR offers diverse branches of pharmaceutical equipment: 

- Pharmaceutical distillers and water systems producing Purified Water (PW), Water for Injection (WFI) and Pure Steam (PS)

- Pharmaceutical Formulation and Processing systems for IV solutions and drugs manufacturing

- Pharmaceutical Filling and packaging systems for pharmaceutical products

 

PURIFIED WATER, WATER FOR INJECTION & PURE STEAM PRODUCTION

BRAM-COR pharmaceutical water treatment systems are designed to produce compendial  

  •     PW - Purified Water
  •     WFI - Water for Injection
  •     PS - Pure Steam

The key features of our projects, which cover every water processing step, from supply water to the machine to the end-product, entail: diversified options for water treatment, critical parameter monitoring, conformity with quality norms and requirements, consumptions, microbiological inspections, functioning, maintenance, production cycle’s costs…

The choice of suitable materials for pharmaceutical use is weighted with particular emphasis. The product is exclusively in contact with certified stainless AISI 316L steel, with a standard roughness ≤ 0.4 µm. A perfect grip is ensured by EPDM/PTFE gaskets. Advanced Technology analytical processes are applied in the continuous quality checks: the automation used in BRAM-COR systems is professionally developed and compliant with GAMP.

See these related websites, too: waterforinjection.comvapor-compression-distiller.commultiple-effect-water-distiller.compharmaceutical-reverse-osmosis-systems.compure-steam-generator.com

 

PHARMACEUTICAL FORMULATION & PROCESSING SYSTEMS

BRAM-COR designs, produces and installs entire formulation and preparation plants, starting from specific product characteristics and clients’ requests (URS). Both the preparation, cleaning and sterilisation of the contact parts of tanks and plants, which represent recurrent problems in the pharmaceutical sector, constitute a peculiar prerogative of each project we commit to. 

Customized and personalized solutions for particular disinfection and sterilization requests can be entirely satisfied by BRAM-COR production systems, which ensure excellent costs-performance in each equipment utilised in aseptic processes, such as:

Mixing Tanks, Pressure Vessels and Bioreactors

  • Mixing Vessels
  • Pressure Tanks / Pressure Vessels
  • Reactor Vessels
  • Customized Formulation Tanks
  • Mobile Mixing Vessels
  • Transfer Tanks

Cip/Sip Systems

  • Customized Clean in Place Stations
  • Mobile Clean in Place Stations

Ancillary Systems For Formulation Lines

  • Triblenders
  • Filtration Groups
  • Solution Transfer Circuits through Nitrogen Or Sanitary Pumps
  • Vessels Loading Platforms
  • Laminar Air Flow Cabinets

See these related websites, too: bram-cor-pharmaprocessing.comivfluids-parenteralsolutions.com

 

PHARMACEUTICAL FILLING & PACKAGING SYSTEMS 

BRAM-COR’s pharmaceutical filling plants for bags or bottles can be configured automatically, semi-automatically or manually, depending on the requests specified by the client. The production range, for different capacities of bags or bottles in plastic/glass, is extremely broad and it is capable of fulfilling the most diversified industrial necessities, beginning from a minimum volume of 10 ml to volumes of significant sizes. The process plants are inherently included within the strict and high BRAM-COR quality standards. They are undoubtedly distinguished and praised for their user friendliness related to conduction and functioning, for their reduced costs of maintenance and their long-term durability.   

Bottling lines are completed through different procedures: cleaning machines, capping, crimping, labelling and conveyor belts. The range is as follows:

  • Manual, Semiautomatic and Automatic Filling Machines for BAGS
  • BAGS making machines
  • FORM-FILL-SEAL equipment for PP BAGS
  • Visual Inspection lines for BAGS   
  • Machines for assembling Plugs and Connectors for BAGS
  • Filling Machines for BOTTLES
  • Washing, Stoppering, Capping Machines for BOTTLES
  • STRETCH-BLOW-MOLDING Machines for PP BOTTLES
  • Complete integrated lines including CIP /SIP skids 

For complete pharmaceutical systems and turnkey project, see also: pharmaceutical-turnkey.com

 

 

Ancillary Systems for Formulation and Preparation Lines

According to specific product requirements (viscosity, temperature, oxygen sensitivity, aseptic issues etc.), BRAM-COR integrates his formulation plants
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BFIL Linear Filling Machine for Bags

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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CIP/SIP Systems

The systems are designed to fully meet cGMPs requirements in cleaning and sterilizing practices commonly applied in pharmaceutical process lines.
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CPSG Pure Steam Generator

Clean Steam / Pure Steam. 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 Reverse Osmosis System

BRAM-COR CROS Sanitary Reverse Osmosis Systems are designed to produce compendial Purified Water (PW) and Water for Injection (WFI), too, through several water treatment steps.
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DISS Formulation - Preparation Tanks

Range of preparation lines suitable for any pharmaceutical formulation: reactor vessels, pressure vessels, pressure tanks, mobile mixing vessels, customized formulation and transfer tanks.
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DPSG Single Effect Distiller

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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DTS HEAT/COOL EXCHANGER

BRAM-COR Double Tube Sheet Heat Exchangers DTS are designed to maximize the efficency, while minimizing resistance to fluid flow through the exchanger thus increasing the performance.
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FFIL Linear Filling Machine for Bottles

The FFIL -linear filling machine for bottles- represents an evolution, combining reliability and low maintenance costs.
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GENO Ozone Generator

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 WFI + PS Generator

KOMB is a unique equipment for the simultaneous production of WFI and PS, combining the double functions of a ME Distiller / PS Generator
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LOOP Distribution System

BRAM-COR integrates its equipment with state-of-the-art distribution loops. BRAM-COR Loop design is the result of a careful evaluation of Points of Use delivery criteria.
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NTOS-NTE-TARO Pharmaceutical Conveyor & Turntable

BRAM-COR belt conveyors are designed to satisfy any requirement in the handling of pharmaceutical containers.
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PRTW Water Pretreatment System

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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SCADA Control System

From equipment control to production line supervision, BRAM-COR SCADA systems provide full management control throughout the plant lifecycle.
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SMPT Multiple Effect Distiller

BRAM-COR Multiple Effect Stills Mod. SMPT are designed and manufactured according to cGMP to produce compendial Water for Injection.
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STDA Accessories & Components

Special sanitary components in AISI 316L fit pharmaceutical and industrial lines, such as 316L SS housings for water and air filters
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STMC Vapor Compression Distiller

Vapor Compression Distiller produces compendial distilled water for pharmaceutical applications (WFI), such as LVP, SVP,
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STOC Storage Tank

Bram-Cor range of products includes a complete range of pharmaceutical holding tanks for storing compendial.
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UVITRON UV Reactor

BRAM-COR produces the Uvitron line, a wide range of UV Reactors and Control Units offering advanced technical features.
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VIS Bags Inspection Lines

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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Washing, Capping & Stoppering Systems

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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