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Drug Product

VirtECS Drug Product has been designed to provide great flexibility in describing the fill/finish process

  • Formulation
    • Thaw
    • Raw Materials
    • Buffer Prep
    • Mixing and Conditioning
  • Filling
    • Rates by container size, dosing
    • Line setup/decon
    • Flexible campaigns (single batch, multi-batch)
  • Parts Prep
    • Supports multi-step prep (wash, autoclave, pre-FIT)
  • Post-Fill Operations
    • Lyophilization
    • Capping
  • Suite or Train constraints
  • Expiry and Max Hold Time Constraints
  • Resource usage
  • Shift Schedules

The VirtECS Drug Product logic optimizes the coordination of shared resources and equipment to handle multiple batches in progress to serve multiple parallel filling lines.

Process Modeling / Capacity Planning / Debottlenecking

The ability of VirtECS Drug Product to represent all of the important process constraints provides a virtual copy of the plant. This allows for a wide variety of potential uses. For example, the effect of a proposed capital investment in a new formulation suite or filling line can be measured quantitatively at no cost by adding the equipment the the virtual plant within VirtECS. This analysis may also bring to attention new scheduling challenges that may occur following the addition of equipment, allowing for greater preparation for any process change.

Some applications of VirtECS include:

Quarterly or Annual Campaign Planning

  • Set Target Batches and let VirtECS optimize to fit as many as possible, while satisfying constraints

Quantify increase of capacity enabled by additional equipment

Study New Product impact

Study Site Shutdown impact

Identify Resource Usage peaks

Finite Scheduling

VirtECS Drug Substance brings several additional features to the challenge of finite scheduling.

Through the flexible modeling schema for Drug Product, VirtECS permits the process activities to be modeled at the level of detail suitable for communication of the schedule for execution.

VirtECS Drug Product can update the schedule based on current activity status. The scheduling logic automatically replans the timing of any affected activities. This includes responding to unplanned equipment downtime.

VirtECS monitors the status of aseptic processing times and batch or equipment hold expiry times and alerts the user when expiry is approaching.

When there is a process upset in a multi-batch filling campaign, VirtECS Drug Product provides a facility to allow the planner to abort the campaign and re-start a new one with the desired allocation of in-progress batches.

Users may manually override the schedule using intuitive controls to alter timing, choice of formulation suite or tank, or other preferences that are not easily represented in data tables. In each case, VirtECS automatically recomputes the schedule so that any affected activities are rescheduled. This allows the user to override the schedule in the simplest way possible without the burden of making every subsequent adjustment manually.

A frozen window may be specified to prevent VirtECS from re-optimizing activities within the desired time horizon.