Roller Compaction Technology a Wet Granulation Alternative

Gerteis® technology is able to offer a wet granulation alternative providing continuous manufacturing solution keeping up with the undergoing changes in the Pharmaceutical Industry. We believe the industry will evolve into continuous processing in the next 2 to 5 years. There are already technologies that are compatible and have the potential to support the foreseeable changes. In particular Gerteis® dry granulation technology offers such a solution and is at the forefront of dry granulation technology. Its revolutionary roller compactors offer clients a cost effective and efficient alternative to wet granulation processes and ensure products of a consistent and predictable high standard. Roller compaction is designed as a continuous technology and Gerteis® have made significant developments distinguishing Gerteis® technologies from the average conventional roller compactors.

In comparison to wet granulation processes, Gerteis® dry granulation technology offers significant benefits, including:

Low Start-Up Investment Level – Save Time, Cost and Risk to your Project

A roller compactor system can be operational in 1 week, validated and qualified within 3 weeks. It is a self contained machine with a test standard control system that can be installed into an existing standard process room. In comparison a wet granulation system will take around 3-6 months to commission, validate and qualify. It is complex and the majority of the testing has to be conducted on site.

Reduced Energy Costs and GMP Footprint

Achieving sustainability is a major global goal for the pharmaceutical industry. We understand the importance of considering the impact that internal manufacturing processes have on the environment when expanding or designing a new build. Utilizing dry granulation rather than wet granulation reduces the required processing energy by 90% and reduces the foot print by 85%.

Process equipment, product transfers, process steps and product contact surfaces all significantly contribute to contaminated waste water. Reducing these processes will reduce the cleaning burden. The Gerteis® roller compactor features a high efficiency cleaning design (CIP) and a lean process optimising the use of detergents and minimising effluent water disposal substantially reducing contaminated waste water.

The GMP processing area and plant area requirements are also significantly smaller by comparison.

The use of a Gerteis roller compactor will substantially cut the cost per tablet and will increase output per square meter of used production space.

Efficient Output, Quick and Easy Operation

If real continuous processing is adopted then further efficiency improvements can be accomplished, subject to developing a validation strategy to monitor the feeding system and pre-blending technology to ensure blend uniformity or large batch sizes.

The advanced feed system only takes a few takes a few minutes from powders arriving at the in-feed hopper until discharged as a finished granule ready for tabletting, capsule filling or for sachets. Compared to the wet granulation method the process steps are reduced by 5 or more, reducing potential yield losses and intermediate storage and transport. The reduction in processing steps means fewer personnel are required to complete production.

Traditionally in continuous technologies there is an area of inefficiency during process start up and close down where product loss can occur. However the controlled slow start technology offered by Gerteis®, a stable process ‘steady state’ is achieved in a few seconds, reducing loss.

Wet granulation is able to achieve a stable and repeatable process however it is only possible via a high degree of quality control, accomplished and experienced operators and a quality control system due to the variability that occurs when working with large volumes of materials. With Gerteis® dry granulation by comparison, the volume of product being ‘acted on’ at any moment of time is constant and is in grams rather than 100’s kg, a significant QbD modification, immediately establishing a steady state, this is always problematic if possible for a wet granulation and fluid bed drying process.

Reduced Quality Assurance and Validation Costs

Quality Assurance can focus on a single process with the Gerteis® roller compaction which has shorter steps, reduced or no intermediate and process transfer steps and reduced in-train product. Continuous processing of larger batches significantly reduces sampling and lab analysis costs.

Extensive and variable amounts of validation and critical control activities create risks. A wet granulation line has between 15 to 20 variable critical control parameters such as temperature, air volume and humidity. Gerteis® have a minimal amount of control parameters that are process critical and with the correct equipment are tightly defined and stable, which includes a patented linear force control system. By calibrating this control function a consistent long term, stable and repeatable process is achieved.

This stringent repeatable control enables developers to predict and establish the correct parameters for scale up from R&D, Pilot scale and manufacturing, which is a significant benefit. The latest Gerteis® innovative technology allows process developers to achieve immediate results, saving valuable material costs and development time. In essence Gerteis® technology results in no scale up being required as the process conditions for the roller compactors are both the same on large production and small scale development machines ranging from a few grams to 20kg/hour up to 100kg/hour and up to 400kg/hour dependant on equipment size.

The Gerteis® roller compactor’s product process parameters are established very efficiently at lab scale and can be applied to large production machines by the following day equating to a huge saving in time and cost and eliminating scale up risk. In comparison the conventional scale up of wet granulation parameters that are not linear or easily predictable have to be developed and established meaning considerable validation time and cost. The process allows fewer GMP critical parameters and set points plus the longer batches reduce sampling and analysis costs.

Reduced Processing Times and Increased Flexibility

A Gerteis® roller compactor offers flexibility to accommodate for any future changes, it can simply be lifted and relocated, no filter cleaning requirements and has the capability of running 24/7. While a wet granulation line is mainly fixed as an integral part of the building, the working volumes are relatively fixed at the time of design making it inflexible in comparison.

Gerteis® dry granulation rollers will reduce the costs of your project and subsequent cost per tablet.

For more information or to discuss roller compaction technology a wet granulation alternative please contact Gerteis directly.