The engineering department of STE Tecpharm is organized by areas of work, consisting of the following categories:
• MECHANICAL DESIGN
• PNEUMATIC DESIGN
• ELECTRICAL AUTOMATION
• SOFTWARE ENGINEERING AND PROGRAMMING
Our engineers work together with a pharmaceutical team that specializes in the development of solid products and is highly-knowledgeable about the processes of solid and semi-solid products.
Teamwork is designed for everyday improvement and advancement of our technology: GRANULATORS, WRAPPING, FLUID BEDS, MIXERS, CALIBRATORS AND HANDLING.
All engineers follow the STE design code, based on international standards EN 12445: 2015, EN 13445, EHEDG hygienic designs as recommended by GMP and FDA.
Each project is as unique as each client is, the teams start with a standard design that is customized according to the client’s case study. We use 3D technology to develop each process equipment. Our methodology allows us to have absolute control of the equipment from its inception to its start-up.
ASSISTANCE DEPARTMENT – AFTER SALES
Spare parts supply service for all our equipment.
Commissioning of all of the equipment, previously tested in our facilities.
Our goal is for the after-sales service to provide the customer with added value. We have a team of highly qualified technicians to provide support, both remotely and at the customer’s facilities.
The commissioning of the equipment is carried out on site at the customer’s facilities. Our operators always accompany the customer so that he can handle the equipment himself, and provide support during the production of the first batches.
Our technicians provide training at the customer’s premises and at our own facilities in Barcelona. The training is aimed at operators and maintenance and engineering personnel.
The STE Tecpharm assembly team has great experience in the assembly of process equipment: they work in conjunction with the engineering department, with the electrical automation team and the software department in the processes of purchasing and quality control.
Solid processing equipment requires extensive knowledge, not only in the design of the equipment, but also in installation and positioning, so that the result meets optimum expectations. Our technical team has experience in the assembly of production equipment for large batches and laboratory scale equipment.
QUALITY AND DOCUMENTATION DEPARTMENT DQ, IQ, OQ y PQ
The quality department of STE Tecpharm attends each delivery of machines. We considered that the FAT is one of the most important step in the process.
STE – Customer: Quality Deppartment approves the compliance of the equipment and that it matches the requirements specified by the customer (URS).
Documentation: is delivered in digital format in a tablet in different languages, Spanish, English, German, Russian and French.
FAT | FACTORY ACCEPTANCE TEST
SRS | STE REMOTE SERVICE
Technical Assistance – Remote Service
SRS helps to improve complex process of technical requirements, maintenance and process operations. It will help you to decrease time and as a consequence, to save money.
HOW DOES IT WORK?
STE TECPHARM offers “turnkey” facilities. We have significant experience in the integration of processes alongside our engineering company. We provide real “turnkey” solutions at the customer’s premises.
The installation of process machinery can be difficult, due to the specific requirements of each installation, the location of the AHUs and other peripherals in the technical area. A customised solution is always required so that the equipment adapts to the customer’s facilities, thus ensuring the perfect functioning of the implemented solution.
|Basic project installation + Process technology to be installed||↦||Study and location of process equipment and services||↦||
Construction, installation & start-up
CERTIFICATE OF PRESSURE EQUIPMENT
CERTIFICATE OF THE ELEVATION ELEMENTS
For them, we have set up means to ensure the quality of our products with:
Quality in terms of design and internal control
Quality certified by means of external Accredited Entities
At STE Tecpharm, we design, build and assemble all the equipment enforcing with a maximum of rigor the following current European regulations:
- 2006/42/CE: CE Directive about machinery.
- 2006/95/CE: Directive regulating electrical material.
- 2004/108/CE: Directive regulating electromagnetic compatibility.
- UNE-EN-ISO 12100:2012: General principles for design. Evaluation and risk reduction.
- UNE-EN-ISO 13850:2008: Equipment of emergency stop.
- UNE-EN 60204-1:2007+A1: 2009: Electrical equipment of machines.