Category: Pharmaceutical cGMP Manufacturing

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.

 

Water For Injection – Multiple Effect Distillers

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 […]

Pharmaceutical Water Pretreatment Systems

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   […]

Pharmaceutical Loop and User points

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 Linear Filling for Bottles

The Bram-Cor FFIL pharmaceutical linear filling machine for bottles represents an evolution in the systems of filling for pharmaceutical rigid vessels, combining Maximum reliability, High precision in metering and Low maintenance costs. The process has been designed in order to offer the maximum functional easiness: The bottles are fed through a special sanitary belt A mechanical system provides […]

Pharmaceutical Linear Filling for 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 […]

Processing – Bioreactor and Mixing Tanks for Formulation and Preparation

Bram-Cor offers a complete range of preparation lines suitable for any pharmaceutical formulation: BIOREACTORS (reactor vessels, pressure vessels), MIXING TANKS (pressure tanks, mobile mixing vessels), CUSTOMIZED FORMULATION TANKS (for high purity water mixing with powders), ATMOSPHERIC TRANSFER TANKS. The accurate finishing and the high quality of the materials used in the construction of all our equipment ensure aseptic drug […]

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 […]

Pharmaceutical Engineering – 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”. Click here to see other Bram-Cor pharmaceutical lines (water treatment, processing, filling and packaging systems).  

Water Treatment – Reverse Osmosis Systems

Entirely Made in Italy, CROS sanitary reverse osmosis system is designed to produce compendial purified and highly purified water through several water treatment steps, according to feed water quality and production needs. Bram-Cor Water Treatment Equipment for pharmaceutical lines and plants. A full understanding of the drug production process is the key concept for the correct […]