Category: Project Drivers

BRAM-COR PROJECT DRIVERS

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

BRAM-COR QUALITY SYSTEM

Bram-Cor works following an ISO 9001:2008 certified quality system. Planning, monitoring, testing, identification and recording are baseline issues of our work, from system design to system validation. Continuous Q.A.S. improvement is pursued through a scrupulous assessment of any non-conformity, reflected in the steady revision of our working procedures. No one pharmaceutical critical system is really the same, each plant has different technical features. Achieving pharmaceutical quality at a good quality/price ratio whilst offering the highest customization is our goal: Bram-Cor ensures professional support throughout the system lifecycle, thanks to a rigorous teamwork.

Vapor Compression Distillation (VCD) – WFI Generators

SAFE PRODUCTION OF WATER FOR INJECTION ACCORDING TO GMP AND FDA RULES Water for Injection (WFI) can be produced through distillation or, also, through a downstream unit of ultrafiltration in a Reverse Osmosis system. The more safe methods are the distillation processes, such as vapor compression distillation or multiple effect distillation. Therefore, Vapor compression distillation […]

Sanitary Reverse Osmosis Systems – Purified Water and WFI Generators

Entirely Made in Italy, Bram-Cor Sanitary Reverse Osmosis Systems are designed to produce compendial Purified Water (PW, CROS Model) and “cold” Water for Injection (WFI, CROW Model) through several water treatment steps, including Ultrafiltration (UF), according to feed water quality and production needs. Bram-Cor Water Treatment Equipment for pharmaceutical lines and plants is a wide […]

Pharmaceutical Engineering – Bram-Cor 3D Design

This album presents some 3D design from Bram-Cor Project and Engineering team. Every process follows rigorous cGMP-compliant Standard Operative Procedures. Specification, construction, and verification steps within the lifecycle are carried out according to GAMP “V-model”. The range of pharmaceutical applications of Bram-Cor projects covers a wide manufacturing productions: from Intravenous Fluids and Solutions (IVF) to […]

Multiple Effect Distillation (MED) – Water for Injection Generators

Every Bram-Cor SMPT – Multiple Effect Distiller is designed and manufactured according to cGMP and produced compendial Water for Injection. Each unit contains a number of boiling columns (or effects, stills) with the first column producing pure steam, which is condensed and re-distilled  in the following columns decreasing the operational costs. Heating for evaporation and cooling  for condensation processes are […]

Sanitary Water Pretreatment Systems for Pharmaceutical manufacturing

CUSTOMIZABLE PROJECTS ON FEED WATER EVALUATION Each BRAM-COR PRTW Water Pretreatment System is customized upon a careful evaluation of feed water quality using local water analysis. Raw water can be pre-treated to remove contaminants (such as particulates, calcium and magnesium salts, heavy metals, organics and bacteria) through different steps, including:     UV lamps and control   […]

Loop and User points for Pharmaceutical GMP Manufacturing

Bram-Cor integrates its PW-WFI-PS Generation equipment with state-of-the-art distribution loops. The Loop design is the result of a careful evaluation of Points of Use delivery criteria such as:     Maximum istantaneous flow rate     Pressure & temperature requirements     Sanitization issues     Periodic consumption requirements and duration     Method of delivery […]

Pharmaceutical Filling for I.V. Fluids and Parenteral Bags

Bram-Cor manufactures the BFIL linear filling machine for bags according to CGMP regulations. The equipment is completely validable with all parts in contact with the fluids in AISI 316L mirror polished stainless steel and with PLC controlled electronics. On request it is possible to modify the software and thus the operation of the machine according to […]

Turnkey Project for GMP Manufacturing – Equipment Installation

Bram-Cor provides complete design, engineering, construction, installation and 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. We propose reliable turnkey know-how, engineering and services about: LVP (Large Volume Parenterals) in […]

Processing – Ancillary Systems for Formulation and Preparation

According to specific product requirements (viscosity, temperature, oxygen sensitivity, aseptic issues etc.), Bram-Cor integrates his formulation plants with state-of-the-art: TRANSFER PANELS – to transfer process fluids through multiple process lines TRIBLENDERS –  for air-free homogeneous mixing of liquids and solids SOLUTION TRANSFER CIRCUITS – through sanitary pipelines, pumps, fittings LAMINAR FLOW CABINETS – ensuring aseptic […]

Pharmaceutical Conveyors and Turntables

These customized belt conveyors are designed to satisfy any requirement in the handling of pharmaceutical containers throughout the drug packaging process. Feedlines and output lines to and from production equipments can be specifically dimensioned for different container tipologies, such as glass bottles, PP bottles, small and large volume Bags. Click here to see other Bram-Cor pharmaceutical […]

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