Continuous Manufacturing: Benefits and Implementation
BioPharma Engineering are now the leaders in the market when it comes to delivering continuous manufacturing methods. We delivered one of the first wet and dry continuous manufacturing projects in Ireland in 2008 along with another small volume continuous processing project for our client Eli Lilly in 2016. This one proved to be very high profile. Not alone was it among the world’s first FDA approvals for this technology, it also won a 2019 FOYA Award
The return on investment for the lean delivery model is substantial when you look at reduced cleaning cycles, reduced down time, increased automation, increased quality and output as well as efficiency in overall process. Although the benefits seem obvious and significant, large scale deployment is still in its infancy. Many companies are still in the exploratory or wait-and-see stages for adoption.
BENEFITS
Improved Speed
- Automated DOE’s
- Eliminate Units Ops
- Streamline Tech Transfer
- Rapid Prototyping
Lower Cost
- Better Synthetic Routes
- New Capabilities
- Added Capacity
- Deferred Capital Investment
- Increased Throughput
Improved Quality
- Real Time Analytical
- Steady State
- Equipment is Engineered to Process
- Less Material at Risk
Improved HSE
- Reduced Waste
- Containment
- Smaller Volumes
- Lower Reagent Amounts
- Neat Reactions
ACCORDING TO RECENT ISPE PUBLICATIONS –RECOMMENDED FIRST STEPS INCLUDE:
STEP 1:
Select the strategy for assurance of each critical quality attribute (CQA)
STEP 2:
Build first principals dynamic models and control systems for each unit operation
STEP 3:
Place unit operation models and controls into a plant-wide simulation
STEP 4:
Design plant wide control strategy based on plant wide simulation
cGMP FOR CONTINUOUS MANUFACTURING
- An effective pharma quality system
- Appropriately validated facilities and software
- Determining a state of control
- Dealing with deviations in real time
- Managing segregation of “potential non-forming materials”
To discuss your continuous manufacturing needs please contact Aisling Crowley, Client Relationship Manager on +353857441155 or fill out our contact form here
