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Process Systems

Our hallmark is providing fast, efficient, and cost-competitive turnkey tailored solutions to meet the complex needs of the pharmaceutical industry.

The competitive advantage of  Brinox business approach lies in our ability to execute independent design, manufacture, assembly, and automation of key components of process systems for the pharmaceutical industry in one place as well as assure the compatibility of turnkey process solutions.

Liquid preparations

We have extensive experience in process systems for the production of liquid pharmaceutical preparations:

  • Parenterals
  • Solutions
  • Suspensions

We specialize in process systems for:

  • Metering/dosing
  • Mixing/blending
  • Heating
  • Cooling
  • Vacuumizing
  • Liquid Transfer

Flexible Production of Parenterals

The innovative benefits of Brinox process systems are production lines with a batch size ranging from 10% to 100% of nominal size.

The main processing units are typically implemented as stationary or mobile reactors or mixing vessels.

The auxiliary (e.g. energy) units are installed in the technical area as modular units with a minimum time of installation and optimum space occupancy.

Another advantage of our systems is the automation of cleaning, sterilization, and drying processes.

Case Study

Challenge:

  • Customized solution to ensure the sanitary integrity of the production of large series of injection solutions, the integration of an appropriate process solution to the existing technical space, and compatibility with the existing technical equipment.

Development and Implementation of the Solution:

  • Design and implementation of a customized process system for the production of injection solution in desired amounts based on the flexible system of batch size ranging from 10% to 100% of nominal volume of equipment.
  • Compatibility of the process solution with the existing technical equipment and space - all unnecessary elements within a clean room are removed to the grade D technical areas or to the ‘grey’ areas.
  • Fully automated production of injection solutions as well as automation of CIP, SIP and DIP processes without the need for operator intervention
  • Executing the main mixing receptacle in accordance with the ATEX directive
  • In-line filtration with in-line filter integrity testing
  • Optimization of production and assembly time and space while minimizing production loss.
  • An innovative computer control system that exploits the advantages of centralized processing, archiving, and protection of data for the control and supervision of the operation of the entire production line with computer terminals, placed throughout various production areas and made accessible to users.
Stationary reactor Stationary reactor Stationary reactor in a clean room Mobile reactor Mobile reactor

Filtration and Storage of Injection Solutions before Filling

Characteristics of  Brinox process system:

  • In-line sterilization of the pre-filter and sterile filter with clean saturated steam (SIP)
  • In-line automatic rinsing of the pre-filter and sterile filter with water for injections
  • The solution passes steadily through the filters and prevents early clogging of the filter inserts
  • The storage tanks have the same volume as the main mixer
  • The filter unit (including the filtration housing) is automatically purged
  • In-line integrity test of the sterile solution filter, or the filter for sterile filtering of inert gas

Additional Options:

  • Drying of the entire filtration unit with sterile filtered inert gas (DIP).
  • An additional filter for the sterile filtering of inert gas can be incorporated into the process of a SIP-filtration unit to allow for simultaneous sterilization and drying with a sterile solution filter.
Detail of the injection solution reactor Filtration of injection solutions

Flexible Production of Pellet Coating Liquids

Our process solutions are distinguished by:

  • A special system of in-line metering, which optimizes the intermixing time of slowly soluble components
  • The use of larger stationary and smaller mobile reactors and mixing vessels
  • Flexible connections of reactor and mixing vessels to the pipe system and other reactor vessels

Case study

Challenge:

  • Customized process solution for the flexible production of large batches of pellet coating liquids and the comprehensive adaptation of the solution to the spatial capacity of the building.

Development and Implementation of the Solution:

  • Design and implementation of the process system for the flexible production of pellet coating liquids in batch size ranging from 10% to 100% of nominal volume of equipment
  • Full automation of production and the CIP and DIP procedures
  • The equipment is rinsed with organic solvents and accordingly complies with ATEX directives
  • Optimization of the production time with in-line intermixing for slowly dissolving soluble substances.
  • Compact energetics of the technology production lines, including cooling, heating, vacuumizing, CIP / DIP, and the optimal use of space and time during installation
Stationary and mobile reactor Stationary reactor Stationary reactor for coating fluids

Syrups

For syrup production systems, we particularly focus on:

  • Optimization of time and production safety (recipes)
  • Increase of product quality (dispersion)
  • Increase of product stability (tempering)
  • Automatic metering of raw materials

Case Study

Challenge:

  • Optimize the production time of small quantities of syrup, while enhancing their quality and stability.

Development and Implementation of the Solution:

  • Design and implementation of a process system for the flexible production of syrups in batch sizes from 10% to 100% of nominal volume of equipment, with the inclusion of small volume mobile mixers for the production of smaller batches and pilot batches into the system
  • Optimization of the duration and production safety based on automation of the recipe regime
  • Increase of the product quality using the latest technology for homogenization and dispersion of syrups and the option of sampling and monitoring of the product at all stages of production
  • Increase of the product stability by tempering and maintenance of the product homogeneity, even during storage or waiting for filling.
  • Automatic metering of raw materials
  • ATEX certification option
Complete system for syrups 4500 liter stationary reactors 4500 liter stationary reactor Lower part of reactor with homogenizers Technical area for syrups 300 liter vacuum mixer

Semisolid Preparations

  • For the design of ointments and creams production process systems, we at Brinox focus particularly on innovations for processes for the dispersion and dissolution of active ingredients, and the reduction of the dispersion time.

Ointments, Creams, and Emulsions

In the design of process systems for the production of ointments, creams, and emulsions we especially concentrate on:

  • Introduction of the most up-to-date processes for dispersion and the dissolution of active ingredients
  • Reducing the dispersion time
  • Automatic CIP/DIP systems

Case Study

Challenge:

  • Significantly reduce the time dispersion time of  flexible production of ointments and creams in different batch sizes.

Development and Implementation of Solution:

  • Design and implementation of a process system for the flexible production of ointments and creams in batch sizes from 15% to 100% of nominal volume of equipment
  • 20% reduced dispersion time due to the installation of a disperser, which operates in circulation (compared to the same product with dispersion from a reactor with internal dispersion)
  • A special system for mixing and dispersion with an integrated unit, which can also be used in the preparation of emulsions
  • ATEX certification option
250 liter mixer for ointments and creams SCADA mixer for ointments and creams

Solid Preparations

We have great experience in the area of substance mixing systems for solid pharmaceutical preparations at very high temperatures and low pressures, and with an innovative procedure of quick and easy emptying of viscous melt from the reactor.

Pastilles

Our searching for process solutions in the preparation of raw materials for the production of pastilles is based on modern technologies:

  • Melting processes
  • Mixing/blending
  • Vacuumizing
  • Ingredient cooling

We have extensive experience in the field of:

  • Systems for mixing substances at very high temperatures and low pressures
  • Innovative procedures for quick and easy emptying of viscous melt from a reactor

Case Study

Challenge:

  • To ensure the quality standardization of entry raw materials for the production of pastilles

Development and Implementation of Solution:

  • Project planning and implementation of a process system for melting sugar
  • An innovatively designed solution for melting sugar and melt-drying at high temperatures and very low pressure to increase the quality and stability of final products and to optimize production duration
  • Reliable solution for sealing mixer shafts with barrier fluid
  • An innovative dumper version of crucible, which enables simple emptying, cleaning, and is operator friendly
Dumper version of crucible for pastilles Crucible interior

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