Engineering

ZETA Engineering

ZETA develops engineering solutions for liquid and aseptic processes. The spectrum of our services in this field reaches from support in the development of the production process to drafting of manufacturing drawings for construction of production systems. Our know-how covers everything from the media that are needed for manufacturing active ingredients, the entire upstream and downstream process, batch preparation systems, their cleaning systems and wastewater inactivation. As well as full-size production equipment, we also develop and supply laboratory and pilot-scale apparatus. And of course we provide a maintenance service for all of the equipment we make.

What ZETA Does

Engineering at the highest level is ensured by the ZETA experts’ years of practical know-how and includes the following services:

  • Customised solutions in challenging markets
  • In-house know-how laboratory testing/workshops/mechanistic understanding of processes
  • Flexibility (scope of design phase)/dynamic design process as a shared development path
  • Combination of pilot and product tests, plant with multiple products at different volumes

Customer Benefits

  • Deep/mechanistic understanding of processes
  • In-house know-how for laboratory testing
  • Successful project execution based on extensive experience with many production plant projects
  • Experienced in product development and manufacturing of active ingredients

ZETA Solution Path

ZETA Solution Path is an overall approach along the product development process – from the preclinical phase to phase 4 - to reveal innovation potential of customized solutions, coming up with inspiring strategies for potential savings, risk minimization and optimizing service performance to raise customer satisfaction.

Concept Design

At ZETA we support our customers from the earliest stages of process and plant design. We analyse the project goals, the requirements of the process and the needs of the operator, and experienced project engineers convert these into specific solutions and specifications, which in turn form the basis for the further design phases and project planning. The concept design phase already sets out the roadmap for and efficient configuration of the processing technology and for the practical execution of the project. In all of this design work, the ZETA specialists never lose sight of the two key dimensions of feasibility and profitability.

In dialogue with the customer, and investing their experience, their competence, their creativity and enthusiasm, ZETA engineers then prepare the following documents:

  • Project quality plan (PQP)
  • Process flow diagram (PFD)
  • User requirements specification (URS)
  • Risk analysis (GMP, EHS, HAZOP)
  • Layout with building dimensions, processing systems, GMP zones, Ex zones, personnel movements and material flows
  • Room schedule
  • Cleaning concept
  • Main equipment specifications
  • Automation concept
  • Qualification strategy and concept
  • Mass and energy balance sheets
  • Media consumption list including cleaning (CIP) and pressure drop calculations
  • Process simulation
  • Analysis of variants
  • Feasibility study with cost estimates and execution plan
  • Concept design report with presentation

Basic Engineering

In the basic engineering phase, the results of the concept design phase are developed further into a design of a specific project, laying the foundation for an efficient and successful project. All requirements for the processing system and its ancillary systems (the building and its technical installations, and utilities) are refined in the basic engineering phase and are designed in accordance with regulations, standards, process requirements, usability and ease of maintenance. At every stage, the ZETA specialists bear in mind the feasibility of every feature of the design. The design is also done in compliance with the regulations of the FDA and EMA and the principles of GMP and QbD.

In close consultation with the customer, and investing their experience, their competence, their creativity and enthusiasm, ZETA engineers then prepare the following documents:

  • Project quality plan (PQP) (continuation)
  • Process flow diagram (PFD) (update)
  • Process descriptions
  • Pipework and instrumentation diagram (P&ID)
  • User requirements specification (detailed) (URS)
  • Layout with building dimensions, processing systems, GMP zones, Ex zones, personnel movements and material flows (continuation)
  • Design of pipework routes
    • Room schedule (update and greater detail)
    • Cleaning concept (continuation)
    • Main equipment: specifications for every single equipment
    • Equipment list
    • Sensor specification, for each individual sensor/instrument
    • Sensor list
    • Specification of fittings, for each type of fitting
    • List of fittings
    • List of pipes
    • Automation concept (continuation)
    • Automation configuration
    • Risk analysis (continuation)
    • Qualification strategy and concept (continuation)
    • Test and documentation matrix
    • Test sheets
    • Mass and energy balance sheets
    • Media consumption list including cleaning (CIP) and pressure drop calculations
    • Process simulation (greater detail)
    • Cost estimates and execution plan
    • Tender documents
    • Basic engineering report with presentation

Detail Engineering

In the detail engineering phase, the results of the basic engineering phase are further refined and specified. The design of the whole system and of all its individual components is worked out in detail in close consultation with the customer. This customer-oriented design work is what ensures that the customer's requirements are fulfilled exactly. The products of this phase are all the documents needed for the construction and installation of the system, such as manufacturing drawings for racks or platforms, and isometric drawings with lists of parts. Perfect coordination of construction and installation improves the project workflow and reduces the time to completion of the project.

In close consultation with the customer, and investing their experience, their competence, their creativity and enthusiasm, ZETA engineers then prepare the following documents:

  • Project quality plan (PQP) (continuation)
  • Process flow diagram (PFD) (update)
  • Process descriptions (continuation)
  • Pipework and instrumentation diagram (P&ID) (continuation)
  • Functional specifications
  • User manual
  • Layout with building dimensions, processing systems, GMP zones, Ex zones, personnel movements and material flows (continuation)
  • Planning of pipework routes (continuation)
  • Room schedule (continuation)
  • 3D model including bill of materials and reviews with customer
  • Fabrication drawings for the whole system (isometric drawings with parts lists, racks, platforms, special parts)
  • Assembly instructions
  • Equipment list (continuation)
  • List of sensors (continuation)
  • List of fittings (continuation)
  • List of pipes (continuation)
  • Software design specification (SDS)
  • Hardware design specification (HDS)
  • Risk analysis (continuation)
  • Mass and energy balance sheets (continuation)
  • Media consumption list including cleaning (CIP) and pressure drop calculations (continuation)
  • Cost estimates and execution plan
  • Detail engineering report with presentation
 
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