Turn key capabilities

Developing Complete and Complex Projects

Since 1912 Stilmas has been continuously improving its knowledge and technical capabilities in clean media treatment in order to reach the highest engineering standards, always in compliance with the worldwide pharmacopeias and to be in the position to offer complete Turn Key systems to its Customers.
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Complete engineering on every single project, 3D layout drawings elaboration for each system, manufacturing of generation, storage and distribution equipment, commissioning installation and start-up, are the fundamental elements of customized Turn Key solutions that Stilmas can offer to its Clients.

Pure water turn key

Complete Pure Water Systems

The key point of any pure water system in the pharmaceutical industry is to grant a proper and constant quality of the water at the point of use.

Pure water systems are considered as a unique entity, without the traditional separation between the “generation” and the “distribution” part. The critical point is that water must be produced with a proper quality, and also stored and distributed while maintaining said proper quality.

For this reason more and more Pharmaceutical Customers look for a reliable supplier to be a partner in the making of a complete Pure waters generation, storage and distribution package.

 

Stilmas’ organization is characterized by:

  • Deep and continuously updated knowledge of the latest pharmaceutical regulatory
  • Strong engineering know-how and organization, as well as modern engineering tools and software
  • Purified water, water for injection and pure steam generation equipment construction and testing capability
  • Storage and distribution loop components and piping construction and purchasing
  • On site equipment and loop components & piping installation capability, with internal installation teams and skilled yard managers
  • Experienced start up engineers
  • Capability in terms of Design, Installation & Operation Qualification, as well as a Performance Qualification support

 

Based on all of that, Stilmas is in the position of being a solid and reliable partner for the realization of any complete pure water pharmaceutical system, everywhere in the world.

On request, Stilmas is able to act as a turn-key supplier for the whole process area for sterile and non-sterile liquids production factory, including:

  • Basic and detail engineering for pure water systems, as well as preparation system
  • Purified water, water for injection and pure steam generation equipment construction and testing capability
  • Storage and distribution loop components and piping construction and purchasing
  • Preparation areas, including preparation reactors, mixing, sterile filtration, product distribution
  • On-site equipment and loop components & piping installation
  • Start up and SAT
  • Full Design, Installation & Operation Qualification execution, as well as Performance Qualification support

 

Engineering

Make It Possible

 

Stilmas provides the following services to its customers:

Consulting | Feasibility studies | Preliminary and detailed designs

In addition to regulatory compliance issues, state-of-the-art technology and expertise are critical to our clients. Such technology and knowledge come from a good engineering design made of:

  • Knowledgeable technical department
  • Specific engineering “know-how”
  • Totally updated project, in compliance to cGMP standards
  • Up-to-date engineering tools

Automation

Making the Systems Alive

Stilmas equipment and systems are equipped as standard with PLC controller with Human Machine Interface. A wide range of configurations is available, based on the use of widely applied brands and models of PLC, from Siemens, Allen Bradley, Schneider electric, Mitsubishi, etc. The HMI – operator panel can be selected according to customer specific needs. All the PLC controllers are standardly able to be connected to factory supervisory systems, via the most common interfaces like Ethernet, Profibus, control net, device net.

 

The whole Software development and implementation is performed by Stilmas automation department according with the latest edition of GAMP. The main activities of the Automation Department are:

 

  • Software design
  • Software development
  • Software organization
  • Software documentation
  • Testing
  • Installation
  • Filing

On request, Stilmas can even provide complete SCADA systems for the supervision and control of the Water Systems; SCADA system are developed basing on iFIX, RSView 32, Win CC, etc, and are realized in strict accordance to 21 CFR part 11 requirements.

Site installation

Complete Systems Realized and Installed On-Site

During the years, Stilmas has developed the capability of producing and installing on site full generation, storage and distribution systems.

 

Stilmas’ site installation organization includes:

  • a number of internal fully certified installation teams, including certified welders and site assistants
  • very experienced yard managers, with several years of experience in the Company as site supervisors in important installation everywhere in the world
  • installation tools including welding machines, bending, cutters etc. These tools are packed into dedicated 20’ workshop containers, shipped by Stilmas to the installation site
  • specific procedures, fully integrated in Stilmas Quality Management Plan, to grant the quality of the site installation in full compliance with the latest international regulatory

Thanks to all of that, Stilmas is ready to take full responsibility for the site installation of complex projects in any area of the world, being totally independent and self-sufficient, and without any special assistance from the Customer.

 

Stilmas can offers a wide range of services related to validation through its organization, specialized in functional areas.

cGMP COMPLIANCE & VALIDATION AREA

Stilmas cGMP Compliance & Validation area organizes and develops validation activities with the “Validation Life-Cycle Approach”, which sees Validation as a traceable and documented evidence for all the activities developed during Life-cycle systems, from the user requirements definition up to the validation maintenance during the routine operation of the system.

Stilmas can organize and implement the following activities:

  • Training program of personnel on validation and GMPs related topics
  • Validation master plan preparation
  • User requirements specification preparation (URS)
  • Functional & design specification preparation (FDS)
  • Design qualification (EDR: Enhanced Design Review)
  • Validation protocols preparation, “Site” tests execution & validation reports preparation for:
      • Installation Qualification (IQ);
      • Operational Qualification (OQ);
      • Performance Qualification (PQ);
      • Process Validation (PV).
  • Planning & Execution of instruments calibration at final user site
  • Computerized control system validation as per GAMP and 21CFR part.11 requirements