Pharmaceutical engineering specialised in high activity plants, sterile products, biotechnology, dry, liquid and topical forms.
Engineering projects specialised in: high power, parenterals, biotechnology, R&D, microbiology and quality control, general form plants.
Our engineering focuses on the design of all the specialities: civil engineering, structures, clean rooms, air systems, auxiliary installations, fluids, dust collection, electricity, access control, fire fighting, sizing of pharmaceutical process technology installations, packaging, and legalization.
We offer a complete service: EPC, EPCM, construction management, audits and consultancy, executions, after sales, training and maintenance contracts.
The conceptual engineering project phase serves to identify the technical and economic feasibility of the project, and how we can set the course for the development of basic and detailed engineering. Our long experience in the pharmaceutical industry, and consolidated knowledge in GMP / FDA allows us to conduct a preliminary study (feasibility study) and a definition of the requirements of the conceptual engineering project, always focused on the needs of the customer.
This includes the engineering documents that define the global and conceptual scope of the engineering project, including the type of technology and equipment specifications to be used.
The Documentation of the conceptual engineering project:
Overall project definition
Engineering project – Building + installations
Process and production machinery project
Product types – Annual production
Basic and/or detailed project appraisal
Basic and/or detailed project planning
Offer of other services
Indicative time frame with activities, resources, times and milestones
The basic engineering design phase is generally associated with an economic and financial feasibility study: for one or two solutions that emerge as the most suitable in the previous phase, details of the design are given including field studies, especially of a topographical, geological, geotechnical, hydrological and hydraulic nature. In the engineering project, details are provided of the unit costs of the materials and of the different construction phases. This process serves to provide a project cost estimate closer to reality.
The Documentation for preparing a basic engineering project:
Design bases and criteria (validation and verification of the Conceptual Engineering).
Definition of the definitive functional requirements.
Flow Diagrams of Principal and Auxiliary Processes (personnel and materials).
Definitive designs including calculations (of all the specialties involved in the project).
Description of the process and philosophy of the definitive Operation and Control.
Definitive Requirements for Complementary Goods and Services.
Definitive major equipment specifications (As-Built documentation and engineering plans for each system).
Piping and instrumentation diagrams.
Specifications of scope of construction by discipline.
Specification sheets for instruments, equipment and inputs.
Control system specifications.
Control system architecture.
Cost assessment for whole project +15%.
A detailed engineering project is the set of documents generated from the Basic Engineering. These include all the construction details by discipline (Civil, Mechanical, Process, Electric, Telecommunications, Instrumentation and Control, Computer Systems) which must be approved for construction. This process serves to provide a closed project cost estimate. The objective of STE ENGOPHARM is to offer an engineering project result without deviations in time and cost.
The documentation of the detailed engineering project:
Confirm the feasibility of working in terms of normative and functional constraints.
During this study phase, we usually define the distribution of space, personnel flows, raw materials and packaging materials, finished products and waste. There is also defined the utilities needed in the development of project design such as HVAC classification, air handling ..
We ensure the viability of the project..
Considering all productive basic facets, spaces and equipment needs and description of major facilities.
In this phase, the spaces are adjusted to every need, flows of personnel and equipment are confirmed, classifications and air systems (HVAC) and other facilities needs are envisaged such as purified water (EP WFI), steam air, electricity and other fluids.
Detailed development of all sub-projects.
At this stage, we develop the details of each system in terms of quality, time and cost, adjusting the real needs of pharmaceutical production processes. The result leads directly to the execution of estimates and proposals without needing subsequent studies. From the quality of the project working depends successful installation.
Service: SUPPORT FOR SUPERVISORY AUTHORITIES
We perform the execution of the project through the development of an implementation project and adjusted quantitative slip to the reality of each installation and sub project. Plans and documentary record of the installations as executed are delivered to customer
Qualification and Calibration DQ IQ OQ
Our team of technicians is specialized in qualification of critical facilities (HVAC, compressed air, treated water, production facilities, climatic chambers and laminar flows).
Calibration Measuring elements (T, P, RH).
Validation of computerized systems in accordance with 21 CFR Part 1.
Editorial approvable execution protocols by the customer in all languages.
Delivery of report of qualification services performed
Commissioning and start up
Our team of expertized technicians provides start-up services and technical training according to the needs of our customers.
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2. Content of the web and links.
STE ENGIPHARM, S.L. cannot be held responsible for the misuse which may be made of the contents of the company web page, this being the exclusive responsibility of the person accessing these contents or using them. Neither can the company accept any responsibility for the information contained in the web pages of third parties which may be accessed through links or searches from the web page www.steengipharm.com
3. Exchange or diffusion of information.
STE ENGIPHARM, S.L. declines all responsibility which may arise from the interchange of information among users through its web page. In particular, the company cannot be responsible for the use that persons under age may make of it in the case that the contents to which they may have access could damage their sensitivity.
4. Updating and amendment of the web page.
STE ENGIPHARM, S.L. reserves the right to update, amend and eliminate the information contained in its website and the configuration and presentation of it at any time, without previous notice, and without assuming any responsibility as a result.
5. Recommendations over technical aspects.
STE ENGIPHARM, S.L. accepts no responsibility which could arise from technical problems or failures of computer equipment not imputable to the company, which may occur during connection to the Internet network, as well as damage which could be caused to third parties through illegitimate intromissions outside the control of STE ENGIPHARM, S.L.
The company is also freed from all responsibility for possible loss and damages which the user could suffer as a consequence of errors, defects and omissions in the information delivered when this is derived from outside sources.
6. Treatment of the users data.
In compliance with the provision in the Constitutional Act 15/1999, of 13 December, of the Protection of Data of a Personal Nature, STE ENGIPHARM, S.L. advises its clients that any personal data supplied to it will be included in an automated file of personal data, created and maintained under the responsibility of STE ENGIPHARM, S.L. The purpose of this file is to send trading offers in the future over the products and services which may be of interest to the companies clients.
STE ENGIPHARM, S.L. guarantees the security and confidentiality of the data delivered. In this way it undertakes compliance with its obligation of secrecy of data of a personal nature and its duty to keep such data and adopt all means necessary to avoid their alteration, loss, treatment or unauthorized use. Therefore, all information regarding the companies clients will not be used for trading proposals or given to third parties.
The clients of STE ENGIPHARM, S.L. may at all times exercise the right of access, rectification, cancellation and opposition, through a communication in writing to the e-mail address: firstname.lastname@example.org
7. Legislation and jurisdiction applicable.
As a general matter, relations with the companies clients which arise from the supply of the services contained in this web are subject to Spanish legislation and jurisdiction.
The users of the companies web are aware of all the above and willingly accept it.
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