Recent advances in manufacturing technology have encouraged many companies to make the switch from batch to continuous manufacturing. The transition has huge potential in the pharmaceutical industry. How do you know if it is the right decision for you? Here are the advantages and drawbacks of each system to help you decide which one is best for your company.
Batch manufacturing is performed using several discrete steps. After each step, offline quality tests are performed on samples. Batch manufacturing can take up to several months for finished product to be output. Batch manufacturing is often the preferred processing system for small quantity/high quality products such as perfumes and active pharmaceutical ingredients.
- Regulatory: traditional manufacturing methods do not impact speed of product approval.
- Start up cost: if you are new to manufacturing, equipment for batch manufacturing is much lower in cost than for continuous manufacturing and can even be found second hand.
- Waste: batch production reduces the quantity of surplus product that goes to waste if retailers cancel future orders due to a decrease in market demand.
- Time: material may be shipped to different facilities for different steps. Degradation of active ingredients can occur with long storage or holding times.
- Equipment: batch manufacturing requires large scale equipment, increasing the size or number of facilities required. It is also difficult to scale up production within a short time frame when responding to market changes.
Continuous manufacturing involves moving products non-stop through production steps on an assembly line within a single facility. It is a much faster, more efficient process because the hold time between steps is eliminated.
- Automation: automated production, testing, and equipment monitoring eliminates human error/contamination and detects issues with equipment before failure, helping to better predict equipment life expectancy and provide proactive monitoring.
- Scaling: continuous manufacturing can run for longer periods to scale up production and prevent product shortages.
- Tracking/Tracing: product can be defined by time stamp, quantity produced, or raw material input. This allows more specific quantities of defective material to be identified and isolated in case of a failure compared to batch manufacturing.
- Start up cost: there are significant costs associated with retiring old equipment, purchasing new equipment/technology, training staff, and updating infrastructure.
- Regulatory: any new manufacturing technology can cause delays in product approval, even if the process itself is approved by a regulatory agency. However, the potential for improved quality and consistency could soon overcome these obstacles.
Continuous manufacturing technology has the potential to solve the problems of drug shortages and high consumer prices in the pharmaceutical industry. However, other industries such as cosmetics and medical devices can also take advantages of the benefits that continuous manufacturing offers. However, for some companies the high initial start up costs may still outweigh the benefits of this technology.
If you have any questions, please feel free to contact Focal Point Research Inc. We are industry leading OTC Drug, Cosmetic, and Medical Device Regulatory Consultants that you can trust to help guide your company in the right direction.