What is Pharmaceutical Engineering?
Often, when thinking about drugs, the focus is on their development, since the process is immensely slow and expensive. But once we have that drug, once we know how it works in the patient, in what dose it is necessary or how it should be administered, it is time to produce it on a large scale.
Given the criticality of its products, the pharmaceutical sector is highly regulated. The production conditions of any pharmaceutical product are subject to the cGMP (current Good Manufacturing Practices). These ensure that the manufacturing conditions will always be the same and minimize the risk of product contamination. The main premise of GMPs is the safety of the drug for the patient. Making the design of a factory and the process system that can produce under GMP conditions and with the necessary quality standards is not trivial, that is why pharmaceutical engineering was born.
Pharmaceutical engineering is responsible for the feasibility study, design (conceptual, basic engineering and detailed engineering), optimization, tendering, project management and qualification / validation of the plant.
- Design: the design phase is usually broken down into 3 stages:
- Conceptual engineering: based on the customer’s initial requirements (products to be manufactured, pharmaceutical form, toxicology, sales forecasts, necessary areas, etc.), the available facilities and taking into account the applicable regulations, the distribution of spaces and equipment is proposed. At the end of this phase, the investment budget planned to achieve the desired production can also be identified. Therefore, this phase also helps companies to make the decision to continue developing the project or to look for other investment alternatives.
- Basic engineering: from the bases established in the conceptual phase, all the main and auxiliary equipment for production, their location, and the necessary services that they require are defined.
- Detailed engineering: based on everything worked in the 2 previous phases, the facility is completely defined (up to the maximum point of detail), with the aim of generating sufficient documentation for the installers to present their offers and execute the design.
- Tender: once the detailed engineering is completed, all the tender documentation is issued in order to be able to compare technically and economically the different offers received by the installers. Different tender packages are usually generated. The final objective of the tender is to award the execution of each package to the installer that best suits the client’s needs (quality, resources, costs and project execution time).
- Optimization: it is common for processes and their elements to become obsolete over time. Optimizing them to reduce costs and manufacturing times is key to the profitability of the company. This stage is increasingly important, as the advances in automation and digitization of pharmaceutical processes grow.
- Qualification/validation: after installation and commissioning there is a set of verifications and tests that serve to ensure that an installation/equipment/process works as expected, without negatively affecting quality of the final product and complying with the regulations.
One of the most exciting things about pharmaceutical engineering is that each plant is different, and with each new project come new challenges. This is because the products, capacities, the pharmaceutical form and the degree of automation change in each case. Each of these parameters has specific regulatory requirements that make the design different (for example: a generic oral solids plant is very different from a biotechnology plant where monoclonal antibodies are produced). In addition, a plant usually produces several different drugs, so it will be necessary to combine the different process elements to have an optimal and versatile production, eliminating any possibility of cross contamination, while complying with the established standard.
Among the most frequent pharmaceutical forms we find:
- Patches and ODF (Oral Dissolvable Films)
- Sterile injectable
- OSDF (Oral Solid Dosage Forms)
- Aerosol sprays
- Syrups and solutions
- Sterile non-injectable
Pharmaceutical engineering requires continuous training. Mainly, by two factors. On the one hand, innovation in equipment and techniques is constant, so we have to be prepared to always offer the best solutions for our clients. On the other hand, regulatory changes are also common, especially now that biological medicines have established themselves on the market, offering a new world of possibilities.
Why should I hire a pharmaceutical engineering company to carry out my projects?
Some pharmaceutical laboratories undertake and execute engineering projects on their own without having a pharmaceutical engineering specialist. Surely, the project will end up being carried out and the product will end up being manufactured, but it is highly probable that along the way there have been significant delays and, especially, design errors that imply changes in the facilities (equipment that does not fit in the rooms, incorrect dimensions of pipes or non-drainable low points, poorly optimized conduit and pipe routing, etc.). Inevitably, this will translate into very significant cost overruns, which will be much higher than the costs derived from hiring the services of a specialized engineering company.
How do we add value in Klinea Pharmaceutical Engineering?
At Klinea, satisfying the needs of our clients is a priority. That is why we accompany them in all phases of the project (be it the construction of an entire plant or just a change in a part of the factory). In addition, we support decision-making so that our clients have the best solutions to the most critical problems. These are the factors that differentiate us:
- Experts in the process:
In our team we have engineers, pharmacists and biotechnologists with extensive experience in the sector. We analyse the production process and identify the needs and critical points for the subsequent development of a tailor-made solution based on knowledge and technical rigor under the required quality standards (GMP, FDA or others).
- Digital transformation:
We go further and design a project aligned with the latest applicable technological advances. We provide the infrastructure with a possible immediate or adaptive automation according to future needs.
- Quality driven:
From the beginning of the engineering project we have the support of our quality department. They are in charge of defining the quality strategy together with the client and ensuring compliance with standards and good manufacturing practices throughout the design.
- We are not an installer company
Unlike an installer, the services we offer do not depend on which equipment is used. At Klinea, as an independent engineering company, we make sure that the equipment to be purchased is the most suitable for our client’s production. And we direct the installers to meet the agreed deadlines and objectives.
- Project management:
We take care of the comprehensive management of the project ensuring compliance with the schedule, quality and costs from conceptual engineering to commissioning and qualification.
- Construction management
Among our services, we have construction management. Our experience in the pharmaceutical industry and in construction management, allow us to supervise the work with the necessary knowledge so that the execution of the design meets all pharmaceutical requirements.
Hiring a pharmaceutical engineering company for your projects is synonymous with preventing problems. It means ensuring that avoidable unforeseen events will not arise in the development of projects, which would end up causing delays and increased resources allocated. At Klinea we have an enormous experience in the pharmaceutical industry, which, together with the satisfaction of our customers, guarantees our ability to provide excellent service.
If you are interested in knowing us more and how we can help you, contact us: email@example.com