Quality and Commercial Gains
Quality was the original driver of PAT, as it not only ensures that you are producing a consistently high-quality product, but the regulator can be assured of the same. This, in turn, can result in a reduced burden of regulatory oversight.
If you currently experience a high level of reject or reworked product, improving quality will have immediate, tangible financial benefits for your business.
Reduced Analytical Laboratory Costs
The reduction in analytical laboratory costs is a direct benefit that occurs as the automated quality assurance on your process, as controlled by synTQ, becomes a reality. In theory, analytical testing can be ultimately eliminated, apart from the functions needed at the beginning of a PAT process. However, in reality, some elements of the laboratory are inevitably retained, even if these functions have been reduced to surveillance and cross-checking.
Another area that can be driven by synTQ is automating laboratory functions. If PAT has not been implemented, there may be more and more demands placed on your analytical laboratory. Many of these functions are repetitive and could be automated. Both liquid and solid product handing for analysis can be managed, which further minimizes the cost of analytical testing.
Dramatically Increasing Productivity and Reducing Manufacturing Infrastructure
Experienced synTQ users have demonstrated dramatic increases in productivity and reductions in manufacturing time.
Naturally, this introduces a choice for businesses – you can either produce the existing demands from a dramatically reduced infrastructure; or you can produce dramatically more from the existing infrastructure, possibly removing the need to build more infrastructure to expand.
Reduced Manufacturing Footprint
If you are not changing manufacturing technique (for example, if you plan to continue using batch technology) then by dramatically increasing productivity, your total manufacturing hardware infrastructure requirement is reduced. Huge footprint savings are possible because of this – productivity has been reported to increase three-fold and manufacturing hardware requirement reduced by two-thirds.
In addition, if you use synTQ to change from batch manufacturing to continuous manufacturing then the decrease in manufacturing footprint is even greater.
Reducing or Eliminating Waste
A synTQ-controlled QbD process measures and controls quality, therefore, in theory, waste and rework should be eliminated.
Unfortunately, reality is not always as straightforward as theory. It is fair to say that with a PAT-centric process, waste and rework can be virtually eliminated. There may occasionally be an outlier edge case, but the vast majority of product entering the process results in quality, finished goods.
The effective elimination of waste and rework can bring about huge financial and production time -benefits, facilitating the journey towards just-in-time manufacturing.
Although it is not normally the main driver for the implementation of PAT, some manufacturers find that the automated quality assurance PAT provides is of great interest. Quality assurance with PAT is permanent and unalterable, with full traceability and data integrity. This means that the possibility of operator transcription error is eliminated and the data can be quickly presented to any auditor with confidence.
Reduced Giveaway Through Quality
For some industries, the effect of PAT on improving the consistency of quality – i.e., reducing the variance in quality – means that you can reduce product giveaway.
This leads to a tangible return on investment and often the technology has a very short payback period. This potential commercial benefit can be applied to most industrial sectors.
Reduced Time and Cost of Development and Manufacture
Whether your development programme has embraced QbD and synTQ, or whether you are implementing PAT straight into manufacturing, huge savings are possible. These savings can be optimized if a QbD development approach has been used but, nonetheless, PAT applied directly to manufacturing can invariably deliver significant, tangible benefits with a rapid return on investment.
When considering a single unit operation, PAT via synTQ can accelerate the process and enhance output product quality by measuring the quality in real time. Therefore, the wastage of time and energy can be avoided, while a higher quality product is produced.
Measuring product quality at key points removes the need for manual “in process checks” (IPCs), delivering huge savings in time and cost. Extended unit operation and IPC times can result in some batch processes traditionally taking nominally 30 days to complete. By employing synTQ on that same process, the nominal time shrinks to a mere 30 hours.
If that same process was converted to continuous production – a technique that may not have been possible without synTQ – then the processing time can collapse to 90 minutes. There are proven instances of savings on this scale.
Flexibility of Raw Material Supplier
Generally, a process is designed and a recipe developed with a specific raw material supplier for each ingredient (or, at best, a small number of raw material vendors). For any one material there may be many possible suppliers and supply options change over time. However, whilst all ingredients may have to comply with a standard, there will always be acknowledged variability. Depending on the robustness or sensitivity of your process to certain ingredient attributes, it may not be able to cope with certain attribute variations when the process is traditionally controlled.
With a PAT- and synTQ-based approach, together with process understanding, you can characterize the raw materials and then feed forward to later processing stages, modifying the recipe to suit the measured characteristics. Therefore, you have considerably more freedom in selecting a raw material supplier, which can dramatically reduce the cost of manufacturing and enhance business sustainability.
Further benefits are possible if you transition from batch liquid to continuous liquid processing. Some processes that require certain starter materials to run a batch process are able to change synthesis technique and run with much lower cost starter materials in a continuous (flow chemistry) process. This can result in dramatic financial savings, whilst the quality of the finished product is unchanged, if not improved.
Reducing Energy Consumption
There are several ways in which PAT can reduce energy consumption. Firstly, by manufacturing more from your existing infrastructure, the energy input per unit of product is dramatically reduced.
The use of PAT also prevents unnecessary manufacturing. For example, you can detect when a blend or a drying process is complete, and so instead of using energy to over-blend or over-dry, you can stop, shorten the process, and reduce energy consumption.
Finally, if you use synTQ to convert your process to continuous processing, then, sometimes for dynamic reasons, it becomes possible to run the process in a quicker and less energy intensive way than could previously be achieved with a batch process. An example of this can be found in certain pharmaceutical processes that must use energy-inefficient wet granulation when processed with batch, but can be switched to faster, energy-efficient direct compression when processed continuously.
Patent Life Extension
Many products, including pharmaceuticals, are patented early in their development lifecycle. With the traditional R&D approach, this results in many years of valuable patent life being lost before the product comes to market. In fact, in many cases, more than half of the patent life is lost before the product reaches the market.
By employing a QbD and PAT approach, the R&D timeframe can be reduced – this can be further enhanced if continuous manufacturing is embraced. Armed with data, information, knowledge, instrumentation, calibration models, and process understanding – i.e., a comprehensive and scientifically based documentation set – regulatory approval should be a faster activity, resulting in your product reaching consumers much sooner. Anecdotally, we understand that some producers have released their products to consumers two to four years earlier than would have been possible without synTQ.
Real-Time Release Testing
A holistic implementation of synTQ is achieved by tracing product quality through the process: from the input raw materials through key quality stages to the final product. This method enables a Real-Time Release Testing strategy, meaning that your final products no longer need to be quarantined for post-manufacture testing, they can immediately be packed and released for sale.
This again reduces analytical laboratory testing, speeds up manufacture, reduces work-in-progress and enables just-in-time manufacturing.
Enabling Continuous Manufacturing
The vast majority of manufacturing processes are not currently robust enough to run in a continuous mode without automated quality assurance. A process must have the capability to rapidly and automatically measure the critical quality attributes of raw materials, intermediates, and finished goods, and then control the process using these measurements.
Of course, this is exactly what PAT, and synTQ specifically, can provide! Regardless of whether you are processing liquids, pastes, slurries, or solids, there is a good chance that the process can be converted from batch to continuous. This transition has a huge number of potential benefits – indeed, this approach has the potential to deliver virtually every benefit listed in this section.
Just-in-Time Manufacture and Reduced Work-in-Progress
In some processes, the production process may be unstable, as product is frequently reworked or scrapped, or there is a high dependence on manual IPC checking, the timing of which depends on pressure on the analytical laboratory. In circumstances such as these, the use of PAT can enable faster manufacturing and the elimination of manual testing. The amount of rework and waste can either be eliminated or, at worst, dramatically reduced. This results in the adoption of just-in-time manufacturing, which dramatically slashes the time and cost spent on work-in-progress.
Employing a PAT manufacturing approach will result in a greener manufacturing process. Firstly, as highlighted above, there will be a reduced energy requirement due to the greater productivity per unit produced and shorter processing times. Furthermore, thanks to the reduced or eliminated waste output, the consumption of raw materials per unit produced is lower. This means that the need to landfill or incinerate waste product is greatly reduced and may even be eliminated.