Service 16 / 27 · Pharmaceutical Process Engineering
Engineering Around the Manufacturing Process.
Process engineering starts from how the product is manufactured and lets that sequence shape the equipment, rooms and utilities. Batch flow, capacity, transfer methods and cleaning requirements are defined with the client process and quality teams. The facility is then arranged for efficient operation, maintenance access and future expansion.
Engineering phases
Where this service fits
03 / 09 phases in scope
- 01Feasibilitynot in scope
- 02ConceptIn scope
- 03Basic EngineeringIn scope
- 04Detailed EngineeringIn scope
- 05Procurementnot in scope
- 06Constructionnot in scope
- 07Commissioningnot in scope
- 08Validationnot in scope
- 09Operationnot in scope
Scope
What the service covers
- 01Manufacturing process review and batch flow
- 02Equipment arrangement and capacity
- 03Process sequence and transfer methods
- 04Equipment interfaces and process utility connections
- 05Cleaning, maintenance access and future expansion
Method
From inputs to deliverables
INInputs
05 items- I01Product portfolio and dosage forms
- I02Process description or master batch information provided by the client
- I03Batch sizes and capacity target
- I04Existing or preferred equipment
- I05Cleaning and changeover expectations
WORKActivities
05 items- W01Process mapping and sequence definition
- W02Batch flow and capacity analysis
- W03Equipment arrangement studies
- W04Transfer method and interface definition
- W05Cleaning and maintenance access review
OUTDeliverables
05 items- D-16.01Process description and batch flow diagrams
- D-16.02PFDs and preliminary P&IDs
- D-16.03Equipment list and arrangement drawings
- D-16.04Capacity and utility consumption summary
- D-16.05Process interface and utility connection schedule
Technical detail
Process engineering topics
Contents · 08
01 / 08
Manufacturing process understanding
The process is documented step by step before any room or equipment is fixed.
- Process description review
- Unit operations
- Critical process steps identified with the client
- Product and material characteristics relevant to design
02 / 08
Batch flow
Batch movement is mapped to minimize waiting, crossing and unnecessary handling.
- Batch sequence
- Campaign and changeover patterns
- Holding points
- Flow separation
03 / 08
Equipment arrangement & capacity
Equipment is sized and arranged so that the target output is achievable with realistic utilization.
- Equipment sizing
- Utilization assumptions
- Equipment arrangement
- Bottleneck review
04 / 08
Process sequence & transfer methods
Transfer between steps is defined early because it drives room adjacencies and levels.
- Step-to-step sequence
- Manual or mechanical transfer
- Gravity or closed transfer where applicable
- Container and intermediate handling
05 / 08
Equipment interfaces & process utility connections
Each item of equipment is connected to its utilities, controls and the building through a defined interface.
- Utility connection schedules
- Process utility demands
- Control and signal interfaces
- Building and structural interfaces
06 / 08
Cleaning requirements & CIP/SIP considerations
Cleaning approach is considered in equipment selection and arrangement, where applicable to the process.
- Cleaning approach
- CIP/SIP considerations where applicable
- Wash areas and equipment cleaning flows
- Cleaning utility demands
07 / 08
Maintenance access
Service access is planned so that maintenance can be carried out with minimal impact on clean areas.
- Service zones and technical areas
- Equipment removal routes
- Access from technical corridors where applicable
08 / 08
Future expansion
Space, utility capacity and routing are reserved so that future lines can be added with limited disruption.
- Reserved space
- Spare utility capacity
- Expansion interfaces
- Phasing options
Process flow
Generic manufacturing flow
An educational, generic sequence; the actual steps depend on the product, dosage form and process defined by the client.
01 / 07RAW MATERIAL
Raw material
Receipt, sampling and quarantine.
Select a step to read what it involves.
RAW MATERIAL
Raw material
Receipt, sampling and quarantine.
DISPENSING
Dispensing
Weighing materials for each batch.
PROCESSING
Processing
The unit operations that form the product.
INTERMEDIATE HOLDING
Intermediate holding
Controlled holding between process steps.
FILLING
Filling
Primary filling or packing of the product.
PACKAGING
Packaging
Secondary packaging and labeling.
FINISHED GOODS
Finished goods
Storage pending release and dispatch.
Deliverables
Typical documents and outputs
- D-16.01Process description and batch flow diagrams
- D-16.02PFDs and preliminary P&IDs
- D-16.03Equipment list and arrangement drawings
- D-16.04Capacity and utility consumption summary
- D-16.05Process interface and utility connection schedule
Services
Related services
- 03
Facility & Architectural Design
Pharmaceutical architecture shaped by the process, the people and the flows between them.
- 13
Pharmaceutical Water & Clean Utility Systems
Pretreatment, generation, storage and distribution engineered as one coordinated water system.
Next step
Planning a pharmaceutical project?
Share the product type, the current stage and the main constraints. We will respond with a proposed scope and next steps.
+20 101 171 1700