Pharma

Brinox process units for the production of solid products are designed to offer a high degree of repeatability, control of GMP parameters and a high level of operational safety. Ou tried-and-tested solutions ensure the highest level of quality.

Therefore, the users of the Brinox equipment are ensured a high level of safety for both manufacturing operatives and patients. 

In using Brinox coating systems, innovative solutions for the preparation of  solids and a high level of automation (control and regulation, data collection and processing, alarming, visualisation, recipes and reports) we ensure the versatility our units and make them easy to use in any setting.

Our units for transfer of powdery materials (MHS) provide different levels of operator protection (OEB 1-5) allowing Brinox users to improve existing systems or build new systems for the production of granules, tablets and capsules.

Preparation of solutions for wet granulation

Our key solutions for the production of systems for wet granulation are distinguished by:

  • a special in-line dosing system
  • flexible connections of reactor and mixing vessels to the pipe systems or other reactor vessels
  • use of organic solvents or only water
  • standard volumes available (2, 5, 10, 20, 50, 100, 170, 250 l) or client required capacities can be produced
  • designs can incorporate or have a combination of mixer types: Brinox standard or customised versions, magnetic stirrers, etc. 
  • designs can be built to incorporate support services as necessary, e.g. CIP, Heating / Cooling, etc. 

Our solutions comply with customer requirements and provide flexible production of granulation solutions. The same transport containers can be used for the preparation of coating suspensions and granulation solutions.

High-shear granulation and drying

Our solutions for granulation and drying in the high-shear mixer granulator/dryer ensure:

  • standard volumes from 5 l to 2000 l or client required volumes upon request
  • use of organic solvents or only water
  • vacuum drying by use of process air
  • a special in-line dispensing system for dicharging of granular powders, which optimises granulation time
  • the use of a torque control measures to determine the completion of the granulation
  • the use of a top shear mixer
  • a special system for optimal utilisation by means of sleeve cooling after completion of the granulation
  • integration of the high-shear mixer with a fluid bed
  • the use of a high-shear dryer for drying substances prior to granulation and after granulation,
  • designs can be built to incorporate connection to either own CIP or to a central CIP / DIP system. 
Drying, agglomeration in a fluid bed

Our solutions for the drying and agglomeration production lines in a fluid bed provide:

  • the universality of the drying and agglomeration device and patented coating solution for pellets
  • standard volumes from 5 l to 2000 l or client customised volumes 
  • use of organic solvents or only water
  • a wide range of inlet air temperature from 20°C to 80°C
  • the possibility of pneumatic filling and discharging of the fluid bed and connection with the granulator
  • designs can be built to  incorporate connection to either own CIP or to a central CIP system
Additives and Blending

Formulations for solid products are associated with the choice and bledning of different substances with the active ingredient. The size, shape and other properties of the powder particulates are of crucial importance in the blending.

Our Brinox blenders and containers (IBC) achieve results that meet with our clients requirements.

We provide:

  • The safe introduction of additives to ensure compliance with the prescribed OEB and explosion safety (with our Brinox MHS systems).
  • We manufacture our won IBCs, allowing us to meet the customers' specifications and introduce required blending. 
  • We offer the production of bespoke blenders, tailored to meet the requirements of our customers.
Preparation of coating suspensions

We combine the use of dissolvers, various types of homogenisers and systems for the separate preparation of additives to meet with our clients requirements. 

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We can provide options:

  • the use of organic solvents or only water,
  • of standard volumes (2, 5, 10, 20, 50, 100, 170, 250 l) or custom-tailored,
  • of various capacity mobile containers adapted for manual transport,
  • of installation of mixers to meet requirements, 
  • of connection to central CIP / DIP systems,
  • if heating or cooling is required, the unit for preparing film-coating solutions can be connected to support system. 

The same transport containers can be used for the preparation of coating suspensions and granulation solutions.

Units for gravity transfer of powder

We can provide our gravity based powder transfer systems over single or multiple floors. These system are automated, enabling the transport of containers with semi-finished products.

 

Brinox docking stations and single-storey lifts, for various shapes and capacity, are a guarantee for the flexible management of materials for the production of solid products, 

Our material transfer solutions are designed to meet the required degree of protection of operators from the harmful effects of chemical substances (OEB).

Brinox units are adhere to explosion safety requirements (ATEX), based on the properties pf the powders. 

By careful selection of components for the units, and with proper use, GMP requirements can be achieved.

Washing units

Our carefully designed solutions for off-line washing and washing-in-place provide proper turbulence of the washing medium, temperature control, detergent concentration control and the quality of the final rinsing water.

Our approach to skid production ensures that outflows pipes are made of suitable materials and are carefully installed. This ensures a high level of reliability of washing and drying in place.

Given the complexity of the products, we provide a solution enabling separate collection of the first rinsing water and special chemical processes to treat the waste water until it becomes ecologically acceptable.

Off-line washing units are adapted to the parts that are washed. As with CIP system units, the choice of materials and washing processes is one of the basic components of quality in the design of off-line washing units.

References
Alkermes
Bionorica
Dottikon
Pharmstandard
Aerie Pharmaceuticals
Capsugel
CSL Behring
GlaxoSmithKline
Johnson & Johnson
Galderma
Lonza
Fresenius Kabi
Merck
Sandoz
Krka
Leo Pharma
Teva
Novartis
Takeda
Lek
Sotex
Alcon
Zoetis
Pharmathen
Pfizer
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