BRAM-COR S.p.A.

Via G. Mercalli 12/A, Quartiere S.P.I.P., 43122 Parma
Italy

Telephone +39 0521 538711
Fax +39 0521 538770
info@bram-cor.com

Hall map

interpack 2017 hall map (Hall 8a): stand B06

Fairground map

interpack 2017 fairground map: Hall 8a

Our range of products

Product categories

  • 06  Machines and equipment for the production of pharmaceuticals and cosmetics
  • 06.01  Complete lines for the production of pharmaceutical and cosmetic products

Complete lines for the production of pharmaceutical and cosmetic products

Our products

Product category: Complete lines for the production of pharmaceutical and cosmetic products

Turnkey Projects

A turning point for Biopharmaceutical Industry
We provide complete design, engineering, construction, start-up of new pharmaceutical facilities, even assisting the Clients through scouting activities of potential Know How Licensor, transferring the Know How, providing Validation Master Plans and Standard Operating Procedures, validating, aligning industrial processes to URS and regulatory requirements.

BRAM-COR PROPOSES RELIABLE KNOW HOW & TECHNOLOGIES ABOUT:
  • LVP (Large Volume Parenterals) in PVC or PP bags 
  • LVP in Glass or Plastic Bottles 
  • SVP  (Small Volume Parenterals) in Glass or Plastic Vials and Ampoules 
  • Pre-filled Syringes 
  • IV products (bags, glass and plastic bottles)
  • Blood bags (LVP bags in PVC)
  • Dialysis concentrate solutions and powders (Canisters, Bags, Cartridges)
  • Plasma Fractionation
  • Biotechnological Plants
  • Multipurpose Pharmaceutical Plants

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Product category: Complete lines for the production of pharmaceutical and cosmetic products

Pharma Equipment

LINES AND PLANTS FOR PHARMACEUTICAL PURPOSES
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. Our Bram-Cor work breakdown structure consisting in following activities:

  • Design (quality by 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 
  • Spare Parts  
Bram-Cor involves its proven experience in three ranges of pharmaceutical equipment:

WATER TREATMENT SYSTEMS
Bram-Cor pharmaceutical water treatment systems are designed to produce compendial  

  •   PW - Purified Water
  •   HPW - Highly Purified Water
  •   WFI - Water For Injection
  •   PS - Pure Steam
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.

PROCESSING SYSTEMS
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

  • Mixing Vessels
  • Pressure Tanks / Pressure Vessels
  • Reactors Vessels
  • Customized Formulation Tanks
  • Mobile Mixing Vessels
  • Atmospheric Transfer Tanks

Cip/Sip Systems

  • Customized Stations
  • Mobile Stations

Ancillary Systems For Formulation Lines

  • Triblenders
  • Filtration Groups
  • Solution Transfer Circuits Through Nitrogen Or Sanitary Pumps
  • Vessels Loading Platforms
  • Laminar Air Flow Cabinets
 
FILLING & PACKAGING SYSTEMS 
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.

  • 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 

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Product category: Complete lines for the production of pharmaceutical and cosmetic products

Full Services

BRAM-COR PROFESSIONAL SERVICES
Top quality cGMP equipment must necessarily be integrated through a proper high level of professional services including:
  • Technical Documentation
  • Factory Acceptance Test
  • Endotoxin Test
  • Installation (see related page in this site)
  • Commissioning, Site Acceptance Test & Start-up
  • Training
  • Validation
Our worldwide network of skilled agents and our affiliated companies ensure assistance to our Clients in over 50 countries, from the very beginning of a pharmaceutical project throughout decades after start-up. Bram-Cor After Sales Dept. grants punctual and quick deliveries of spares and ongoing technical support.

 
ENGINEERING & TECHNICAL DOCUMENTATION
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 
A complete technical documentation is part of our machines 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 
  • Spare Parts 

DQ - DESIGN QUALIFICATION
During the initial phases of the process we assist our Clients with a feasibility study and an engineering support due to optimize the entire project from the overall investment point of view, considering operational costs reduction. In case of Critical Fluids Systems (PW, WFI, PS), we usually ask to provide us with following basic data:

  • Raw water analysis
  • Table of concurrent uses in the 24 hours (ask for more information)
  • Lay-out with location of each user point, as well as of the equipment (we are ready to assist the Clients in defining the most suitable layouts)
Through our software we can perform all necessary simulations and recommend the best solutions. Either counting or not on our initial engineering support, we provide a complete set of specifications in our DESIGN QUALIFICATION protocols, which are submitted to our Customer for approval before starting the equipment construction.

COMMISSIONING 
Commissioning includes factory testing, site testing and start-up activities, ensuring that the system is correctly running and that the final product meets all specified requirements within the operating range.

FAT & SAT PROTOCOLS  
BRAM-COR systems are first pre-tested in our facility, tested in the presence of the Customer during FAT,  and finally tested on site (SAT) under real operating conditions by professional and competent Bram-Cor technicians. Product critical parameters are carefully monitored, as well as fluid flows, pump duties, alarms, valves, emergency power and software modules. Our FAT and SAT protocols provide a complete documentation of testing activities.
 
TRAINING OF THE END-USER
The necessary training for operation and maintenance of Bram-Cor pharmaceutical systems is provided by our expert technicians at the system start-up, ensuring a full understanding of how the equipment works and how to operate for effective sanitization/sterilization and troubleshooting.

Different training for different access levels to the system is taken into account and recorded on Bram-Cor certificate of attendance. Action options and limitations for the End-User, which are diversified according to the access level, are cleary highlighted during training.

 
VALIDATION PACKAGES
Validation of a pharmaceutical systems implies careful verification of functional and design specifications, to make sure that the final product meets all regulatory standards. Bram-Cor standard validation package includes:

  • INSTALLATION QUALIFICATION  The documented verification of the system design is achieved by checking the as built equipment versus the design specification. IQ protocols include as built drawings, part lists, electrical schemes, software documentation. Our IQ protocols provide easy-to-fill check lists. 
  •  OPERATIONAL QUALIFICATION  The documented verification of the functional design is achieved by checking functional data against the functional specification. OQ protocols are conceived for easy recording of critical parameters and provide full support for effective system validation. 
 
TELESERVICE
Our Customer Service provides effective after sales assistance, focusing on quick problem solving. The direct communication with our Customers and the full traceability of all system components enables us to easily detect the problem cause and to suggest the most suitable corrective action. Teleservice can be also configured on Bram-Cor systems to ensure quick feedback by our Automation Dept. Special care is given to safe remote access policy for compliance with 21 CFR PART 11. 

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About us

Company details

BRAM-COR CUSTOMIZED PLANTS - A PHARMACEUTICAL POINT OF VIEW
 

Made in Italy, made in Parma: our headquarters is located in highly specialized industrial district, heart of the Italian food valley and of the European Food Safety Authority (EFSA). Parma is the capital of advanced technologies in industrial food machineries and production lines. Dating back to 1964, our diversified know-how and field experience in developing and manufacturing water treatment systems from COR S.r.l., filling lines and packaging equipments from BRAM S.p.A. are today joined together in BRAM-COR S.p.A., a leading company in customized pharmaceutical technologies and in biopharmaceutical turnkey plants. Our target in design, manufacturing, documentation, testing and validation activities focuses on the overall compliance of our equipment to the needs of the pharmaceutical and biotechnology industry. International Good Manufacturing Practices and Pharmacopoeias are the baseline to our work. This landing page (that opens a new window) shows where our lines and plants are working all over the world (web site: www.pharmaceutical-equipment.eu). 

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Company data

Target groups
  • Cosmetics
  • Pharmaceuticals