Genesis’ process engineers approach every project with the appreciation that one size doesn’t fit all, especially when it comes to drug manufacturing. Understanding your processes and needs, we provide right-sized design solutions whether starting with a greenfield site, working within the constraints of a retrofit, or simply troubleshooting performance issues.
Our process modeling informs key business decisions and creates core process deliverables that capture the design basis and refine the project scope. We are creative and flexible to meet your goals ranging from short duration/low cost to fully redundant depending on the project goals and constraints. Adapting to your specific needs, our robust designs will help you operate in a consistent and compliant manner while never sacrificing on quality.
Key Areas of Expertise
Advanced Therapy Medicinal Products (ATMPs)
Single Use Equipment
Aseptic Processing
Oral Solid Dosage
Active Pharmaceutical Ingredients (API) Synthesis
Process Scale-Up
Core Process Deliverables
Block Flow/Process Flow Diagrams
Process Equipment List
Process P&IDs
Material and Energy Balances
Utility Usage and Diversification
Process Equipment Specification and Submittal Review
Additional Services
Process Modeling
Simulation of Processes and Utility Systems (Monte Carlo)
Facility and Process Equipment URS Development
CIP/SIP Flow Paths
Utility Connectivity Strategies
PharmaWater Pro™ – It is a unique and proprietary water system design platform for energy analysis, utility system upgrades, facility and infrastructure projects.
Risk Assessments – traditional Process Hazards Analysis (PHA) for flammable chemicals and dust explosion hazards as well as typical process operations, GMP risk assessments, Contamination Control Strategy (CCS) development, and FMEA methodologies. We facilitate, scribe, report and provide SME participation and review.
Process and Manufacturing Models
WFI Distribution Loops
Chemical Distribution Systems
Manufacturing Capacity
Time-and-Motion Study
Production Simulation – proprietary simulation tool by Genesis
Faster than software tools that require licenses
Simulate an entire plant’s manufacturing throughput (units/time)
Process Timeline (batch simulation)
Equipment histograms, forecasting and utilization
Utility and buffer/media requirements
Staffing requirements
Utilization of drums/bins/SUMS
Wastewater Inactivation and Neutralization
Process Consultancy
We have many instances of helping clients with unique problems. See below for representative examples:
Alcohol recovery: our solution involved perfusion coupled with distillation to recover IPA from two waste streams
Odor control: we assessed an existing odor control system that client was unable to operate successfully after two years of trying, and within a short turnaround time, our team solved the challenge, offering not just one solution but six recommendations to choose from
Foaming issues: we pinpointed root causes for excessive foaming in the shampoo plant drainage system with recommendations that could be retrofitted in that plant and rolled out for implementation in new builds throughout their global network
Tank mixing: we designed a jet mixer to ensure uniform ozone distribution in a PW storage tank
Dry Heat Oven cooling: we created hydraulic and heat transfer model to size flow orifices at the cooling water coils to ensure that the water would not reach boiling within the DHO
