CHEMICAL AND PHARMACEUTICAL ENGINEERING
Feasibility studies, in a technologically advanced environment and with strict regulatory requirements, are key to investment decision-making.
A study identifying the investment and operating costs with a reasonable degree of uncertainty in order to define the return on an investment (ROI), is one of the first documents to be handled when embarking on an investment.
TRESCA Ingeniería has a team of professionals with over 20 years of experience in the preparation of Feasibility Studies with the capacity to identify the construction, assembly and equipment supply costs (CAPEX) and operating costs (OPEX) of a facility, apart from establishing the relevant maps of permits and risks associated to the investment.
DESIGN AND PROCESS REVIEW
DESIGN AND PROCESS REVIEW
Engineering review and approval services are performed in accordance with applicable national and international standards and codes, those used in the process or area concerned (FDA, EMA) and the usual ones (ASME, API, NEC, NFPA, ASTM, etc.), and may include as-built drawings and the use of specialised software.
This involves independent design review combined with Factory and/or Site Inspection Services.
Design and process review services are necessary when performing a process scale-up optimisation and integration into an industrial plan.
TRESCA Ingeniería from its technical department, provides a comprehensive service to prepare a technical-economic document on which a decision can be based.
COMPARATIVE TECHNICAL STUDIES
COMPARATIVE TECHNICAL STUDIES
A comparative study of part of the process or of the needs of specific equipment can make the difference in the final design of a plant.
TRESCA Ingeniería, has a team of professionals with a deep knowledge of market options capable of analysing different technologies and their implementation in the process and in balance of the plant.
Conceptual Engineering is necessary to identify the technical and economic feasibility of the project and sets out the guidelines for basic and detailed engineering development.
It is based on a previous study (feasibility study) and the definition of the project requirements.
It is the first phase or stage of a pharmaceutical engineering project, being the phase for establishing the objectives desired by the user, the type of technologies to be applied, the framework of technical standards that will regulate the designs, and the criteria for economic assessment and for profitability calculation.
Once defined, the bases or standard criteria from the financial or credit institutions are reconciled with those established by the client in order to develop various design options (called cases) and the project profitability assessments or rate of return for each case.
The purpose is to choose the option for developing the next phase or for resolving to cancel the project due to low profitability.
Basic engineering plays an essential role in developing a project in order to establish and clarify the basic guidelines to be developed in the detail engineering..
Basic engineering will finally reflect all the user’s requirements, basic specifications, the execution schedule and the economic valuation.
TRESCA Ingeniería carries out all the tasks that are part of this phase:
- Defining and fitting the setting process of the basic criteria for each installation:
- Voice and data
- Preliminary routing of pipes, cables and other devices.
- Revisions (equipment drawings, flow diagrams of main processes…)
- Preparation of diagrams (flow diagrams of main processes, piping and instrumentation processes, etc.) and single-line circuit diagrams.
- Preliminary studies and calculations (of hydraulic, electrical, structural systems…, operating conditions, weight and dimensions of equipment).
- Lists and specifications of equipment such as valves, piping, etc.
- Budget estimates.
Detail Engineering or Detail Design is the phase in which each and every subsystem, component or part that make up the project is defined.
It aims to define the execution of the project with such precision that documents developing such project must be sufficient to put it into practice, either under the direction of the design engineers themselves or by a different engineering team.
Once we have the basic data for the project, this is subjected to a refining stage, aimed at working on those details that may be a weak point for the execution of the project.
The objectives for this phase are:
- To check and confirm and, if necessary, modify the scenarios and solutions of the basic design.
- To provide all technical, economic and legal information to the promoter.
- To provide technical data, construction details and conditions under which the project is to be undertaken (or built).
- To serve as a management document in those cases where the preliminary or basic design is insufficient or does not exist. For instance, the documents to be submitted for the company registration with Industry or for the activity licence application.
A technically defined project needs to fit into previously agreed deadlines and costs. Therefore, it is necessary to strictly plan every task to be undertaken and ensure that, from engineering, it is well defined and structured.
All project information must be available to those who need it when needed it and all the information generated must be made available to other actors following a strict protocol.
TRESCA Ingeniería has a set of procedures adapted to the project management in the demanding environment of Biotechnology, Pharmacy or Chemistry.
These procedures are updated and revised in each experience becoming a never-ending source of lessons learned, which helps improve the final result in price, deadline and quality.
Procurement Management seeks to acquire the necessary goods and services for a project, ensuring the supply of required quantities in terms of time, quality and price. Procurement Management has two main functions:
This first function refers to the acquisition by the project of raw materials; indirect materials; spare parts; machinery, equipment,
tools, furniture, etc.; office supplies; services (e.g. transport of goods) and others necessary for the project construction.
Operations support function
This function in changes to the project scope involves acting on price and time limits through
the acquisition and control of the supply sources necessary for the maintenance of the operations process.
TRESCA Ingeniería has a Procurement Management team made up of buyers specialised in the particular features of biotechnological, chemical and pharmaceutical environment, where deadlines and operating conditions and supplies have a very different characteristic from the rest of the industry.
PROJECT AND SITE MANAGEMENT
PROJECT AND SITE MANAGEMENT
The Project and Site Management is carried out by a technician or group of competent technicians appointed by the promoter, responsible for the compliant interpretation of drawings, data and technical documentation of the project, the review of the work, and the completion and issuance of certificates relevant to the progress of
execution and even the final adjustment thereof.
TRESCA Ingeniería has a number of procedures that, interpreted by the specialised technicians on this matter, are part of the framework on which the work phase of the project, its planning and budget control are based, in order to meet the price, deadline and quality goals.
The uniqueness of materials, equipment and technical requirements of the demanding environment of biotechnology, chemistry and pharmacy makes it
necessary to have specialists in this type of work who bring together the required expertise for such a complex environment.
TECHNICAL VERIFICATION TESTS
TECHNICAL QUALITY ASSURANCE TESTS
Good Manufacturing Practices ( GMP ),require pharmaceutical manufacturers to document the control of critical aspects of their equipment, systems, premises and processes in order to ensure the quality of the manufactured product, that the product will not cause any harm to the patient, and the integrity of critical process data.
TRESCA has a team of specialised professionals who determine the qualification or validation scope through a risk assessment, which identifies the critical aspects of equipment, installation or computerised system and defines the qualification and/or validation tests necessary to ensure compliance with both the client’s requirements (URS) and regulatory requirements.
Subsequently, qualification and/or validation protocols are drawn up, as well as the testing execution included in such protocols and previously determined in the risk assessment. A report is issued detailing the qualification/validation tests carried out, as well as the result obtained in each test.