What can we offer you?
OUR SERVICES
We offer our customers personalized services, accompanied at all times by the best engineers specialized in design, distribution and technology.
- PROJECT ENGINEERING
- EXECUTION PROJECT
- ADDITIONAL SERVICES
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.
CONCEPTUAL ENGINEERING
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
- Global project
- Engineering project – Building + installations
- Process and production machinery project
- Product types – Annual production
- Production processes
- Basic and/or detailed project appraisal
- Basic and/or detailed project planning
- Offer of other services
- Technical Feasibility
- Economic Feasibility
- Risk Analysis
BASIC ENGINEERING
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.
- Implementation Layout.
- Specifications of scope of construction by discipline.
- Specification sheets for instruments, equipment and inputs.
- Detailed layouts.
- Control system specifications.
DETAILED ENGINEERING
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:
- Civil Engineering
- Enclosures
- Air Conditioning
- Electricity
- Compressed Air, Steam, Hot and Cold Water
- Purified Water
- Extraction
- Waste Treatment
- Special Gases
- Fire Protection Systems
- Safety
ENGINEERING OF EXECUTION PROJECTS WHICH MANAGES AND CARRIES OUT THE EXECUTIVE DESIGN, SUPPLY, ASSEMBLY, SUPERVISION AND CONSULTANCY. PERSONALISED MANAGEMENT FOCUSSED ON TIME AND BUDGET.
EXECUTION PROJECTS SPECIALISED IN:
TURNKEY PROJECTS, GLOBAL SERVICE OF THE PROJECT IN HIGH QUALITY, RESISTANT AND HYGIENIC ENCLOSURES, HVAC AIR SYSTEMS, EXPERTS IN THE CALCULATION AND OPTIMISATION OF INSTALLATIONS.
Specialists in auxiliary installations both in assembly and start-up, electricity and SIP CIPcleaning systems. We incorporate and install pharmaceutical process and packaging technology. More than 40 years of experience providing services.
Our engineering activity focuses on turnkey execution projects: preparing the documentation for obtaining licences and permits, the implementation of plants, installation of production equipment, start-up and qualification, legalisation of installations. Engineering which offers a complete service: EPC, EPCM, construction management, audits and consultancy, executions, after sales, training and maintenance contracts.
FLEXIBLE AND ACHIEVABLE FOR EXECUTION PROJECTS:
Pharmaceutical installations require very strict standards. At STE Engipharm we design these installations so that they are flexible and achievable solutions. We carry out turnkey projects, covering all stages of the value chain of an execution project of the production plant. We analyse the technical needs of the installations, applying the best technological solutions in HVAC, production equipment, compressed air design, dust collection, waste water treatment, sanitary water, electricity, purified water (PW), BMS. We deliver the As-Built Documentation which includes any modifications to the Detailed Engineering carried out during the project execution, construction and installation. The As-Built Documents are presented as a further review of the Detailed Engineering, and include the set of documents containing modifications to the previously specified design.
The contract management within the execution project includes:
- Preparation of documentation to be delivered
- Supplier monitoring and consultancy
- Preparation of Tables of Comparison
- Assessed presentation to the Owner
- Collaboration in the drafting of Orders
- Delivery of schedules to be met
Project management within the implementation project includes:
- Coordination of Installers
- Monitoring-Update of Planning
- Weekly Meeting – Issue of Minutes
- Coordination with Owner
- Economic Control
- Certifications
- Control of Changes Approval
- Collection of Installation Tests
- Final Documentation – As-Built plans
- Collaboration with Local Engineering
- Safety Coordinator
- Installer Safety Plans Approval
- Sub-Contractors Book
- Incidents Book
- Material Quality Control
- Collection of Installation Legalisation
PROVIDE AUXILIARY SERVICES IN MORE THAN 15 COUNTRIES ALL OVER THE WORLD WITH BROAD KNOWLEDGE OF ADDED VALUE PLANTS, DESIGN, CRITICAL INSTALLATIONS, PROCESS AND PACKAGING TECHNOLOGY, COMPLIANCE SERVICE, GMP / FDA REGULATIONS.
STE ENGIPHARM’S GLOBAL VISION OF THE AUXILIARY SERVICES MAKES IT POSSIBLE FOR US TO HAVE A VISION OF THE CUSTOMER FROM ALL ANGLES.
We offer our customers additional personalised services, accompanied at all times by the best engineers specialised in design, distribution, technology and calculations for successfully developing the design and implementation of an industrial plant.
At the project engineering level we offer:
- Contract management
- Project management
- Support to health authorities
- Audits and consultancies
At project implementation level we offer:
- Complete epc/epcm service
- Training
- After sales
- As-Built documentation
- Corrective and preventive maintenance projects
- Compliance service: qualification, risk analysis, master plan
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RECRUITMENT MANAGEMENT | Tender of different industrial partners involved in the bidding process. Comparison of results. |
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CONSTRUCTION MANAGEMENT | Coordination of industrial partners, planning compliance, economic control, overhaul of works and follow-up meetings. |
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ACCOMPANYING HEALTH AUTHORITIES | Availability of STE technical staff who is knowledgeable of the project to accompany the health authorities, with the aim of supporting the explanation and defence of the project for approval. |
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AUDITS AND CONSULTANCY
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HVAC installations, flows of staff and materials, compliance with regulations, production systems, risk analysis, energy efficiency. |
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TRAINING
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Training courses for technical staff guaranteeing the knowledge of systems and facilities. Our goal is achieving an optimal operation. |
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DOCUMENTATION | Preparing the final work documentation in the customer’s language – As built, qualification protocols, technical manuals, certifications, health and safety documentation. |
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MAINTENANCE CONTRACTS | Permanent contact service with the client, with the aim of continuing the good maintenance of facilities and equipment: Timely and periodic reviews, list of recommended spare parts. |
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AFTER-SALES | Proximity Technical Support to respond within 48 hours: SAT, accessories and spare parts, skilled technicians and 24 hour remote control support. |
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PRODUCTION SUPPORT | In the start-up process of the facilities and equipment, we offer the customer our best qualified technicians in critical facilities to ensure production. |
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FULL SERVICE: EPC / EPCM | We offer our customers a comprehensive solution in the realisation of a project: Engineering, Procurement, Construction and Management. |
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