Which solution-oriented services provide support with recipe development and process optimisation in the pilot plant?
At an industrial pilot plant, a wide range of solution-oriented services is available that support companies in formulation development and process optimisation. They form the bridge between laboratory research and large-scale production and make it possible to develop, test and prepare new products and processes reliably for scale-up under near-production conditions.
Formulation development and formulation design
Solution-oriented services for formulation development include in particular:
Formulation development and optimisation
Systematic elaboration and fine-tuning of new formulations, taking into account raw material properties, target specifications, manufacturing costs and regulatory requirements. Ingredients, concentrations and additives are adjusted so that the desired product properties (e.g. viscosity, particle size distribution, reactivity, sensory quality) are achieved in a targeted way.
Feasibility studies
Assessment of the technical feasibility of new formulations under realistic process conditions, including examination of raw material interactions, process stability and reproducibility.
Raw material screening
Qualification of alternative raw materials and components with regard to technological suitability, performance, cost, sustainability and process stability in the existing plant configuration.
Stability and compatibility testing
Investigation of storage, temperature and application stability as well as material and packaging compatibility, in order to ensure the shelf life and functionality of the formulation across the entire life cycle.
Sample and prototype production
Manufacture of small batches for application tests, sensory examinations, release testing and for validating chemical and physical specifications before transfer to the production scale.
Reverse engineering (optional)
Analysis of existing products in order to understand their composition and critical parameters and to derive optimisation or substitution strategies for the company's own formulations.
Process development, scale-up and validation
For the transfer of laboratory results into robust production processes, the pilot plant offers the following services:
Scale-up studies and trials
Transfer of processes from laboratory to pilot and production scale, taking into account heat and mass transfer, rheology, mixing behaviour and flow dynamics. Similarity characteristic numbers (e.g. the Reynolds or Newton number) are used in order to keep physical effects controllable.
Design of experiments (DoE)
Statistically validated trial planning for identifying and optimising critical process parameters (CPPs) such as temperature profiles, pressure conditions, mixing times or dosing strategies – with a minimum number of trials and maximum informative value.
Validation of the process windows and process validation
Determination of robust process windows within which the process runs stably and reproducibly, as well as evidence of process capability in accordance with quality-relevant requirements (e.g. GMP, internal quality standards).
Equipment specification and technology transfer
Derivation of technical requirements for production plants on the basis of the data obtained at the pilot plant, including support with documentation, training and the transfer of the control recipes into the process control system.
Analysis, quality assurance and troubleshooting
Extensive analytical and diagnostic services are offered in support of development and optimisation:
Physico-chemical characterisation
Determination of central product characteristics (e.g. viscosity, particle size, density, pH value, solids content, conductivity) in order to understand structure-property relationships and influence them deliberately.
Application testing
Simulation of real conditions of use at the end user in order to assess the performance, processability, service life and user-friendliness of the products.
Troubleshooting and root cause analysis
Reproduction of industrial conditions at pilot scale for the systematic identification of process deviations (e.g. agglomerate formation, segregation, foaming, thermal degradation) and derivation of effective corrective and preventive measures.
Process optimisation and efficiency improvement
For ongoing production processes, the pilot plant offers solution-oriented optimisation services:
Process optimisation and debottlenecking
Identification and removal of bottlenecks in existing process chains in order to increase overall equipment effectiveness (OEE), raise output and reduce throughput times.
Energy and resource efficiency analyses
Recording and evaluation of energy, water and raw material consumption in order to derive measures for improving efficiency, reducing costs and reducing reject material and emissions.
Process simulation and modelling
Use of digital models for predicting flow, mixing and heat transfer behaviour and for assessing optimisation variants without intervening in ongoing production.
Digital and data-driven services
Modern pilot plants use digital tools in order to shorten development cycles and increase process control:
Process analytical technology (PAT) and inline instrumentation
Integration of online analysis and instrumentation for real-time monitoring of chemical and physical process variables, in order to detect deviations early and develop control strategies.
Automated batch management and control recipes
Development and testing of automated process sequences (e.g. in accordance with ISA-S88) at pilot scale, in order to prepare later implementation in process control systems and increase reproducibility.
Data logging, process monitoring and evaluation
Systematic recording, storage and evaluation of all relevant process data in order to create digital fingerprints of trial series and to support scaling, optimisation, quality assurance and compliance with regulatory requirements.
Consultancy, regulation and sustainability
In addition to the technical services, the pilot plant frequently offers supporting services:
Technical consultancy and technology transfer
Support with the transfer of developed formulations and processes to the production site, including know-how transfer, training and support with scale-up decisions.
Regulatory support
Advice on compliance with industry-specific standards, safety and environmental requirements and on preparing the necessary documentation (e.g. safety data sheets).
Sustainability assessment
Analysis of the ecological footprint of formulations and processes (e.g. by means of life cycle assessment), in order to develop resource-efficient, energy-efficient and low-emission alternatives.
Through the targeted combination of these services at the pilot plant, development times can be shortened, production risks reduced, time to market accelerated and at the same time a stable, reproducible quality at industrial scale ensured.
The amixon® pilot plant: trials, scale-up and process optimisation with the original product
35 test units – from laboratory scale to pilot scale
At its Paderborn headquarters, amixon® operates a pilot plant with 35 test units of various sizes. Processes can thereby be represented realistically from small scale up to pilot plant; even with limited product quantities, robust statements for the production scale are possible. Pilot plants in Japan, India, Thailand, China, South Korea and the USA are additionally available worldwide.
Real conditions instead of paper values
Mixing processes (mixing, homogenising, granulating, agglomerating, moistening, coating) are examined, as are drying and reaction processes (vacuum drying, thermal processes, syntheses). The trials run with the original product, within the intended temperature and pressure range, with real fill levels and batch sizes and the planned energy input. Mixing quality, product protection, energy input, cleanability and reproducibility in later series operation are assessed.
Joint execution, evaluation, documentation
The trials are carried out, evaluated and documented with amixon® experts. The aim is to select the optimal apparatus and the appropriate process parameters for the specific application, including recipe development and process optimisation. The result is a robust basis for decision-making: confirmation of the process parameters under real conditions, assurance of product quality and economy, minimisation of technical and economic risks before the investment.
Seamless transition into production
Because trial and production mixers work with the same mixing principle (SinConvex® tool, circumferential speed 0.8–3.5 m/s, mixing quality independent of fill level) and sizes are available in 100-litre increments up to 50,000 litres, the pilot-plant parameters transfer directly to the target machine. amixon® also supports product changeovers and scale-up after commissioning, with process engineering, product development and process optimisation.
Manufacture in Paderborn as the quality foundation
amixon® develops and manufactures exclusively at the Paderborn works, with the greatest depth of fabrication and all components from Germany. As a certified welding company with European, Japanese, Korean and American qualifications, amixon® designs every apparatus as a one-off on the basis of the operator's URS; quality control remains entirely in-house, and every specification is verifiable down to component level. This manufacturing sovereignty also secures long-term supply: every component can still be reproduced decades later.
Service across the entire life cycle
After commissioning, amixon® remains at the operator's side: regular inspections and preventive maintenance secure availability, on request with predictive maintenance. Selected wear parts are supplied together with the initial delivery; most spare parts are held at the Paderborn site, many more at the service bases in Japan and the USA, with a lifetime spare parts service, even where original suppliers no longer exist. Many amixon® machines have been in daily use for more than 30 years; modernisation and retrofitting keep them at the state of the art.