Lonza has developed a large number of manufacturing processes in recent years and has gathered a substantial amount of experience in process design. As a result of our simultaneous and team-oriented approach, our process design procedure is integrated and iterative.
In addition to using our global technology network with a wide range of universities, consultants and special expert companies, we have also developed our own process design capabilities.
澳客网安全吗 www.16mfy.com.cn Lonza has the capability to design and develop novel synthetic routes to target molecules, helping our customers find the most efficient, economical and ecological way to produce in multi-ton lots.
Additionally, Lonza supports its customers to find alternative routes (e.g. 2nd generation processes) in a later stage of the life-cycle of the substrates.
Modelling and Simulations
State-of-the-art process design makes use of numerous possibilities of computer aided process engineering tools (CAPE).
We have continuously developed capabilities in rigorous steady-state and dynamic simulation of entire processes or of individual reactions and thermal separation units. The Lonza strategy includes the continuous evaluation of developments in this field and the immediate implementation of appropriate tools.
Chemometric Modeling Techniques - complement to physical modeling and are therefore often applied. Chemometric approaches are also well established tools in laboratory work, particularly to optimize and validate processes already in an early stage of development.
Computational Fluid Dynamics - (CFD) are used for design as well as for optimization purposes. Lonza Group works closely together with universities and special expert companies in CFD.
High Throughput Technologies
Our Performance Chemicals business has made great progress in utilizing an integrated high throughput system to accelerate the innovation rate for new biocides.
A high throughput enabling technologies system (HITT) was designed and installed in the year 2000. The HITT system uses robotics and automation to increase (by orders of magnitude) the throughput rate in the areas of antimicrobial discovery, microbiological screening, formulation development, analytical chemistry and technical services.
Recent Accomplishments Include:
- Rapid identification of a replacement preservative component for a detergent product
- Preparation and screening of 180 synergistic blends of biocides completed in a week instead of several months
Many parameters including temperatures, solvents, catalysts and stoichiometry can be rapidly investigated. Typical working volumes and temperatures range from 10 to 20ml and -30°C up to +150°C, respectively. Samples can be analyzed via an HPLC with automatic sampling and injection.
Process Validation / Registration
Our process and plants are constantly validated and registered to fulfill the requirements of the United States FDA and other authorities. Lonza Group performs the necessary Design (DQ), Installation (IQ), Operational (OQ) and Performance Qualifications (PQ) according to strict Qualification Dossiers.
Lonza is committed to provide customers with products and services meeting all specifications and fulfilling customer needs and expectations. The highest priority and emphasis is placed on the integrity of our products, their safe manufacture and distribution and the compliance with environmental and other relevant regulations.
To achieve these goals, Lonza operates local quality management systems which comply with internal policies as well as with national and international standards (e.g. ISO) and regulations (e.g. GMP, PIC, HACCP).
Scale-up and Process Optimization
To support our process design & intensification activities, scale-down and scale-up tools are used for specific unit operations. The work is supported by process simulation and chemo metric methods to generate and evaluate data from mini or pilot plants.
Instruments like Flexylab, which can process up to four reactions simultaneously, are applied to facilitate parallel processing, thereby speeding up qualification and validation procedures. These instruments feature the same reproducibility as larger systems, but at lower volumes (50-450 ml).?
The ability to supply small quantities (grams to kilograms) of chemical intermediates or?protein therapeutics?rapidly and reliably is a highly appreciated service that Lonza can offer in both its Chemical and Biological Manufacturing groups.? Our new Light Path? Custom Supply Offering, allows customer to purchase small quantities of early phase material for pre-clinical assement.?
Process Intensification (PI) enables Lonza to continuously reduce costs in production processes. Debottlenecking, selection and optimization of unit operations, process simplification and process stabilization are achieved using a variety of chemometric techniques including EVOP, Statistical Design of Experiments (DOE), Statistical Process Control (SPC), Statistical Analysis of (historical) plant data, etc.?
Recipe based project management software is used to summarize relevant project information and to facilitate communication between functional departments.
Whenever possible, Lonza uses catalyst technology to perform effective reactions throughout the entire palette of products including bulk chemicals, intermediates and special fine chemicals. Our catalytic process development team, established in 1984, offers comprehensive expertise starting from the selection of appropriate catalytic systems up to the transfer into a catalytic manufacturing process. We have special expertise in the development of catalytic systems for hydrogenations, oxidations, ammoxidations, and animations to help us to optimize any process.
We use existing core competencies in the scale-up and production of proprietary oxide catalysts for the custom manufacture of non-proprietary catalysts. Lonza has pilot and commercial unit operations for catalyst development and scale-up. Volumes that are produced range from a few kilos up to hundreds of tons (for commercial production).
Pilot facilities are used to provide our customers with samples for approval. In Addition, production costs and the difficulty of the subsequent scale-up can be estimated.
Analytics / In-process Control
The analytical department continues to play an important role in Lonza’s business. Its main purpose is to fulfill the demands in the strictly controlled production of (bio) pharmaceutical & agrochemical intermediates and API's. Mostly chromatographic (HPLC, GC, TLC, Capillary Electrophoresis) or titrimetric methods are utilized to ensure the quality and determine the impurity profiles of products, intermediates and starting materials.
Analytical methods are often transferred from the customer and validated according to internationally accepted guidelines. If no validated methods are available, Lonza develops the necessary methods and transfers them from the development to the QC labs in the plants. Accompanying this development is often the identification and synthesis of all important impurities for their usage as standards.
Multi-purpose production facilities face the challenge of the development of methods to determine trace amounts (often in the ppm range) of products and impurities to control the cleaning procedure in the changeover process steps.
During a chemical reaction it is very important to know the concentrations of different chemical species to monitor (in-process control) and also optimize certain chemical steps. Besides using off-line methods in the laboratories, we possess in our production units a wide variety of in-line analytical systems for immediate response to control the dedicated processes. For the latter, in-line spectroscopic methods (like near infrared (NIR) and mid infrared (IR) and advanced chemometric methods are used to determine the concentration profiles on a qualitative, semi-quantitative or quantitative level. The regular use of in-line spectroscopic methods in laboratories elaborates the potential and the technical possibility of a later plant application already in an early stage of process development. Flexible to handle measurement test equipment is available and effectively supports an early and fast implementation in a plant.
Solid Material Technology
Today the majority of Lonza's products are dispersed solids. The requirements of our customers are not only restricted to the specified chemical properties. The physical properties of the solid material such as particle size, flowability or absence of dust become increasingly important as an additional product value. Our Solid Material Technology Team was established to provide state-of-the art solid technologies. This competence center is focused on the three linked disciplines which contribute to a rapid and competitive processing environment.
- Solid-Liquid Separation
- Particle Forming
- Bulk Power Handling
In close collaboration with marketing, development and production, the engineering department designs and constructs new plants with both continuous and batch equipment. Lonza is able to react quickly to the changing technical and market requirements.
Our qualified multi-purpose plants are modularly designed, allowing them to be quickly and effectively adapted for a wide range of changing product portfolios.
To view full 360° views of our custom manufacturing facilities, visit our Virtual Tours.
Integrated Waste Management
From the start of the planning and engineering phase of a new project, Lonza includes the identification of potential waste sources and the assessment of ecological risks.? Our goal is to minimize waste before it is produced.?
The main elements of the Lonza Group Waste Management Concept are:
- Minimization of waste production throughout the life cycle of a product
- Reuse of unconverted starting materials and by-products wherever possible
- Recycling of solvents at the production unit or in specially assigned solvent recovery units
- Usage of the energy potential of waste products (e.g. production of steam by incineration of organic waste streams)
- The external recycling of unavoidable by-products and waste materials (e.g. transition-metal catalysts)
- (Pre)treatment of aqueous waste streams on-site (e.g. stripping off residual solvents) as well as in state-of-the-art waste water treatment plants
- Incineration of gaseous, liquid and solid waste materials for the production of high pressure steam
- Final disposal of slag from incineration and non-combustible substances in landfills
To accomplish these tasks, Lonza steadily develops and optimizes the production with respect to environmental concerns.