Our services
PHARMACEUTICAL ENGINEERING
Specialized and tailored engineering services for the industry: Pharmaceutical, Biotechnological, and Health Products.
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Pharmaceutical Engineering
Discover everything Konexio Biotech can do for your business in all areas related to pharmaceutical engineering.
- Conducting conceptual, basic, and detailed engineering studies.
- Providing support and scientific advisory on facilities and GMP with regulatory agencies: AEMPS (Spanish Agency for Medicines and Health Products), EMA, FDA...
- Conducting technical audits of facilities.
- Developing user requirement specifications.
- Defining production processes.
- Assisting in the selection of equipment and supporting qualification and calibration.
- Coordinating construction permits.
- Developing sustainability plans and obtaining sustainability certifications.
- Architectural design and production of 3D infographics.
Our Working Process
Discover the working process we follow at Konexio Biotech to shape your project in a comprehensive way.
Step-01
Development of the Conceptual Engineering Design
We assess the regulatory framework and the needs of your production process to define the design and layout that best fits your workflow and regulatory requirements.
Step-02
Definition of Production Flows
Based on the Conceptual Design, we implement all flows of People, Materials, and Processes to optimize production and ensure regulatory compliance.
Step-03
Definition of Key GMP Parameters
We define the key GMP parameters of the facility: classification of viable and non-viable particles, pressure scaling, temperature and humidity limits, decontamination criteria, monitoring, and control.
Step-04
Development of the Technical Project
We develop the basic and detailed engineering, defining the requirements for construction systems, facilities, and services; determining costs, execution times, and control points.
Step-05
Support During Construction
We advise and support you during construction, commissioning, and qualification. This includes negotiation and relationships with subcontractors and installers, project follow-up, problem-solving and interference resolution during construction, reviewing final technical documentation, and support during the Commissioning, Qualification, and Validation phases.
Want to discover more about Pharmaceutical Engineering?
Yes, but we don’t just create physical plans, even in 3D. We consider all the critical factors of the design: optimization of spaces, adherence to regulations and technical guidelines, development of all personnel and production flows, adaptation to processes and equipment, and staff ergonomics. We refine these designs as many times as necessary until we achieve the best possible outcome.
Yes. We conduct a technical evaluation of the installation and also a site visit.
Yes. Prior to the construction of any pharmaceutical facility, we follow the regulated consultation procedure with the relevant regulatory bodies to review the project's feasibility.
Yes. As a multidisciplinary team, our pharmaceutical engineering and architecture team works closely with our quality and regulatory teams to ensure pharmaceutical installations comply with applicable regulations according to the regulatory framework.
Yes. For manufacturers, quality control labs, and warehouses.
Yes. We are experts in this type of facility, whether for cell therapy, tissue engineering, gene therapy, or the manufacturing of secretomes and exosomes.
Yes. Especially for advanced therapy medicinal products that require small-scale facilities or biotech companies requiring a high level of biocontainment.
Yes. We pay special attention to the flows of materials and personnel in these types of facilities.
Yes. Especially for complex equipment, such as sequencers.
Yes. We can also implement the maintenance plans.
Yes. We handle all procedures with the National Biosafety Centre and prepare the necessary documentation.
Yes. Ensuring the highest levels of product safety.
Yes. We also design facilities for AUMEs and food supplements with specific health claims.
Yes. For both MDR and IVDR products. We also have experience designing facilities for medical software manufacturers.
Yes. For biotech companies and businesses with highly innovative production processes.
Yes, we always incorporate sustainability and energy-saving criteria in our designs and technical recommendations. However, we do this in a coordinated, logical, and comprehensive way, based on our experience, common sense, and the correct application of specific sustainability regulations and guidelines.
Monday - Friday: 9:00 - 19:00 h.
