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 […]
Category: Complete Lines & Plants
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 Pure Steam Generator – PS / CS production
PURE STEAM. FROM STERILIZATION TO DIRECT CONTACT WITH A.P.I. BRAM-COR CPSG Pure Steam Generator produces dry, saturated steam, suitable for sterilization of pharmaceutical production plants, for direct contact with Active Pharmaceutical Ingredients, for Parenteral and Non-Parenteral dosage form applications. The steam, when condensed, meets USP requirements for Water-for-Injection. The steam is purified using centrifugal and gravity separation methods. […]
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 […]