A PHARMACEUTICAL POINT OF VIEW
"Made in Italy, made in Parma: dating back to 1964, BRAM-COR 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. The diversified know-how and field experiences in developing water treatment systemsmorefrom COR S.r.l. and in developing filling lines and packaging equipment 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.
BRAM-COR offers a full range of stainless steel equipment focused on the development of IV fluids and parenteral solutions and dialysis products in bags or bottles. All BRAM-COR equipment is fully consistent with Good Manufacturing Practices for the pharmaceutical industry. BRAM-COR work consists in the following main activities: design, construction, testing, documentation, installation, validation and local/remote assistance.
Specification, construction and verification steps within the lifecycle are carried out according to GAMP "V_model", considering risk assessment, architecture of system components, functional specification, sanitisation and validation issues, with special overview to a sustainable maintenance of the system.
In some countries, especially in critical geographic areas, BRAM-COR is required to provide complete pharmaceutical infusion plants with design, engineering, construction, start-up for new pharmaceutical facilities, 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's product range includes:
- Water Treatment Systems
- Pharmaceutical Processing Systems
- Complete Formulation Lines
- Filling and Processing Lines
- Steam Generators
- Ozone Generators
- Reactors and Storage Tanks
- Bioreactors and Mixing Tanks
- Laminar Flow Cabinets
- Washing, Capping and Stoppering Systems
Water Treatment Systems
From Purified (PW) and Highly Purified (HPW) water to Water For Injection (WFI) and Pure Steam (PS), BRAM-COR solutions meet all pharmacopoeias requirements for the pharmaceutical industry. Current GMP regulations require appropriate specifications and monitoring procedures to ensure product quality and safety. Therefore, BRAM-COR water systems are customized to meet the needs of specific manufacturing facilities, manufacturing lines and pharmaceutical products.
BRAM-COR Vapor Compression Distillers, e.g., are a global benchmark for this sector. The STMC distillers generate ultrapure water (WFI) for pharmaceutical applications. In particular, they are used for injection and infusion products, IV fluids and washing solutions. They are also used in other products that rely on compendial water supplies with high purity and sterility, or on removal of chlorine solvents, pyrogens and other contaminants. Furthermore, there are STMC customized models with pretreatment systems integrated on the same skid: STMC AEL/AST, with automatic water softeners, and REL/RST, with water pretreatment + reverse osmosis system. For this reason, Bram-Cor STMC vapor compression distiller can virtually work with any water available on site. This is a key factor for all drugs formulation.
BRAM-COR offers other water treatment technologies, too, including multi stage water distillation, reverse osmosis systems and pure steam generators. In addition, a full range of water pre-treatment and decontamination solutions are available including UV reactors, microfiltration and ultrafiltration systems, ozone generators, filters, softeners.
Formulation and Processing Plants
Based in Italy, BRAM-COR develops and manufactures turnkey formulation and preparation plants for facilities across the globe. Beginning with the requirements of a particular client and product, BRAM-COR solutions provide the optimum balance of performance with cost effective aseptic processing equipment.
BRAM COR processing plants can be customised to meet specific requirements for sterilisation and sanitisation. All BRAM COR processing vessels feature internally mirror-polished AISI 316L grade stainless steel, with thermal insulation and satin finish stainless steel cladding.
The vessel design adheres rigorously to PED standards. ASME S-U stamp and PED certification can be provided for BRAM COR pressure tanks. Each preparation plant can be fitted with SCADA supervisory technology for control of critical parameters and processes.
Bag and Bottle Filling Equipment
BRAM-COR delivers special bag and bottle filling equipment for pharmaceutical applications, especially for small production of high quality pharmaceuticals. The machines are customised for bags and glass / plastic bottles of various dimensions to meet specific client requirements.
BRAM-COR filling machines ensure excellent reliability over the life of the equipment, low-maintenance operation. Filling lines can be supplied complete with integrated capping, crimping and washing machines along with conveyor systems and labelling lines.
The BFIL series (linear filling machines for bags) is unsurpassed for reliability, long lasting and low maintenance costs. These machines provide easy cleaning and different bag formats, smooth operation, functional precision. The equipment is completely validable: all parts in contact with the fluid are in AISI 316L mirror polished stainless steel and with PLC controlled electronics. The equipment supports straightforward sterilisation and cleaning processes, thanks to an entirely linear and stable hydraulic circuit. Each model is endowed with a custom-designed drop grill for collection of any leakage or droplets of solution. The system supports bags with capacities between 50 and 5000 millilitres.less
Considerations: Belt V Direct Driven Compressors for Vapor Compression in Pharmaceutical Distillers
Bram-Cor deliver an article focusing on the comparison of belt driven...article posted by BRAM-COR S.p.A.
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