Step 1: Gather inputs
Every batch is unique. We start by gathering all relevant process characteristics for the batch, including:
- Process flow diagram (PFD)
- Process description
- Facility layout
- Equipment list
- Mass balance
Our team can create flow paths for all Cytiva equipment and assess connectivity to equipment from other vendors.
Step 2: Process inputs
Cytiva’s subject matter experts use specialized design tools to process the inputs provided in the first step:
- The aniPlanner layout tool generates a 3D layout of your facility to visualize equipment installation and determine the parts and configuration required to connect process steps.
- The Batch 360™ configurator creates a consumables flow diagram by matching the equipment list, PFD, and process description with the correct consumables.
Step 3: Batch 360™ workshop
Cytiva’s team meets with you to discuss the output from the design tools. This two- to three-day workshop can be held on-site or virtually, and includes:
- Closure solution(s)
- Processing preferences
- Equipment layout
- Inventory optimization
- Warehouse space requirements
- Regulatory requirements
The team will also provide drawings of single-use assemblies and can start the design of any custom consumables needed.
Step 4: Final deliverables
At the end of the project, you will receive a full package of deliverables including:
- PFD showing all single-use consumables
- Bill of materials
- Volumetric estimate of packages
- Assembly drawings
- Validation guides
- Extractables information