What will this software do
for me?
All manufacturing data is pulled together, organized, and easily
viewable in a web portal that updates every 60 seconds. So, potential manufacturing problems
are seen before they happen. The software integrates with the industry's major equipment vendors
to give you a detailed view of the entire plant in near real-time.
Building on this, third party multivariate analysis, statistical, and
graphical tools can be plugged into the system based on your needs.
An added benefit is the ability to do instant batch release when the entire
production process has been modeled from a PAT perspective.
You can tell at a glance whether an entire batch is good or bad at the end of the manufacturing process.
How hard is it to implement?
Installation of the software is quick and requires a couple of configuration settings to point it to your data.
To fully utilize the benefits of the software, you will need to identify processes and their critical quality attributes (CQA's).
Once identified, they can be built into the system.
The key element of the PAT toolkit™ is it’s ability to allow you to create a "golden" or ideal model for
each of your processes. Using our Process Modeler interface, you can design customized models using
a language quite similar to Visual Basic. This code will help you define the ideal parameters for the process (CQA's)
and automatically create a report detailing how a production run compared to your "golden" models.
These models can grow and change as you discover more information about
the manufacturing process.
You can also design the models to set the disposition of the run (OK, Problems,
Borderline). The software will automatically notify specific people based
on up to the minute progress to make sure things continues to run smoothly.
How long does it take to PAT into a process?
This depends. An entire process from start to finish can take a year or two. Yet, monitoring, analyzing, and controlling one
particular part of the process can be set up in a few weeks. We have some clients that have over 70 processes tied into the system.
It took them 2 years to get to this point.
Tip: With PAT being a long term approach not all of the upfront costs have to be figured into the yearly budget. This can be broken
down into manageable chunks, making it much easier to get approval.
What do you mean by "plant-wide" PAT?
Many of our clients have used the software to extend beyond their processes to also include their utilities systems. Clean in Place (CIP) and
Steam in Place (SIP) can be integrated and monitored as well. Basically, any sensor or analyzer that produces data can be plugged
into the system and monitored.
What is a Critical Quality Attribute (CQA)?
Critical Quality Attributes or CQA's are the key parameters that are vital to a successful process.
Discovering these data points is typically where most of the hard work is in implementing PAT. If
you understand the sources of variability, you can start to monitor and correct fluctuations.
Examples of a CQA could include: temperature, pH, or pressure.
What do you mean by "golden" model?
This is a framework for defining how every aspect of your manufacturing process should ideally behave.
Using the PAT toolkit™, these "golden" models can be built up and developed to whatever level of complexity
you deem necessary all the way from raw materials to batch release. The nice part is PAT toolkit allows a model
to grow and change as you learn and understand your processes better.
How about chromatography?
Currently, a client of ours is using the PAT toolkit™ to analyze and report on the
data from Affinity, Cat-ion, and Gel Filtration chromatography skids.
The skids use the client's preferred vendor's software to control the
process and store the information in an industry-standard data repository.
From this data, critical quality attributes (CQA's) have been determined as well
as operating and alarm ranges that are analyzed in near-real time and
reported to the user group automatically upon run completion. The users
are able to see the reports (in PDF via the web portal) with the process
information displayed against the pre-defined graphical and statistical
criteria that were derived for the applicable process. Access to process
information and approval of the reports is all 21 CFR Part 11 compliant.
Spectroscopy?
Implementing NIR and Raman spectroscopy into an analytical process is best done by building
this information into the "golden" model. For in-line processes the data can be pulled
from whatever database it resides on and compared to the critical quality attributes (CQA's)
within the "golden" model to determine whether the product is good to go
based on the spectroscopy data.
Is this a historian?
No, the system connects to process historians, SCADA systems, and LIMS
to turn your process data into knowledge.
Do you offer training?
Every purchase of the PAT toolkit™ includes one week of training
for up to 2 people in your company. Training sessions are conducted at
our corporate office in beautiful Bozeman, Montana and are offered one week of every
month. The training will cover how to identify the processes that could most benefit
from PAT and then how to use the software to create a powerful golden model to monitor and report
on your manufacturing process in near real-time.
How long is a Demo?
A very brief overview of PAT and the software typically lasts 15 minutes.
However, we are always happy to do a demo of whatever length a client is
interested in. Register for a 15 Minute Demo.
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