Production processes
Pharmaceuticals are produced in a variety of ways, depending on the medicine itself and the desired product. We have extensive experience and expertise in a wide range of production processes.
You can rely on our experience: we have designed several facilities with GMP approvals from the EU, FDA and local authorities.
We start by defining the critical parameters for the production process during the R&D and process development stages of the new pharmaceutical. Based on these, we design the complete production process with the automation system.
Based on the process needs, we develop raw material handling, intermediate processing and equipment for tableting or filling and finishing together with suppliers. In addition to the production process, we also specify the facilities, utilities and all other needed support systems.
We pay special attention to documenting the user requirements, as we want to ensure that everything is suitable for the intended use.
From API to final container
When planning a new production suite of a facility, it is essential to consider logistics and material handling, whether it be raw material, intermediate or final product. We are here to help you.
Process equipment for manufacturing pharmaceuticals varies from reactors and vessels to columns and filters. The intermediates are formulated to their final form – tablet, capsule, inhaler, container or syringe – depending on how the pharmaceutical product is dosed to the patient. In addition to the necessary production equipment and processes, utility generation and distribution must be designed. Warehouses are also an integral part of the production process in a pharmaceutical facility.
Clean utilities, including water, steam and gases, are used in many applications within the facility, for example for ensuring humidity in cleanrooms and for decontamination or sterilization. In addition, products require special waters (PW and WFI).
A well-designed automation system is the core of the production process. The system uses data from process equipment to monitor and control critical parameters and report results. The electronic batch record reduces manual paperwork.
Sound complicated? Don’t worry, we can help define the solutions you need.
From API to final container
Biopharmaceutical processes
Should you manufacture your biopharmaceutical products traditionally in stainless steel bioreactors or in single-use plastic bioreactors? Together we can find the most suitable method for your production.
The need for new pharmaceuticals and vaccines has increased demand for facilities suitable for the production of biopharmaceuticals. Some pharmaceuticals, such as monoclonal antibodies, vaccines and antibiotics, are still produced on a large scale, but the production of smaller batches in single-use containers is increasing.
The pharmaceuticals of the future will be tailored for specific illnesses and therefore produced in small quantities. We have extensive experience in designing facilities for both the large-scale and small-scale production of biopharmaceuticals.
Biopharmaceutical processes
Medical devices
The production of medical devices complies with its own GMP (Good Manufacturing Practice). We are familiar with this and can help with your challenges.
A medical device can be an inhaler or a new way of dosing a pharmaceutical, an analytical device or a test kit for pharmaceuticals, or a solution used for analyses.
Each product, solution or device registered as a medical device should be manufactured and documented according to the GMP requirements for the area or country in which it will be sold. Numerous standards and guidelines must also be adhered to.
We have experience in implementing these standards, requirements and guidelines. In addition, we can design functional facilities fit for their purpose.
Services for Medical devices
Technology transfer
Technology transfer is needed when a production process or technology is transferred from one location to another. We have the expertise required to carry this out effectively.
In addition to the technical challenges involved in a technology transfer project, document management creates a lot of work. Utilizing the documentation from the existing production and bringing it up to date for the new production often requires manual work and good organization.
Risk assessments, action plans and a thorough follow-up of progress are essential for a successful technology transfer within a short timeframe. Our templates and data warehouse-based solutions provide a transparent way of working and monitoring progress.
Services for Technology transfer
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