Device-Focus: Connecting Big Pharma’s Scientific Lab Instruments For the First Time
A Q&A with Phizzle's Chief Innovation Officer, Michael Patrick.
Mike, you are Phizzle’s go-to lab instrument expert. What exactly does that mean?
I’ve been working in the device space for 30+ years. Prior to my position at Phizzle, I worked as a consultant designing hardware and software for customers ranging from garage inventors to NASA contractors. Most of the projects that I worked on involved sensor-based data processing ranging from a simple temperature probe to an infrared sensor in the nose of an anti-ballistic missile.
Can you explain what a scientific lab instrument is for those outside of the pharmaceutical industry?
This is any device that a technician uses to measure a particular characteristic of a given sample. The devices that we work with have some kind of electrical interface that allows a computer to read the results of the measurement and/or control the operation of the device.
How do these instruments work and what do they measure?
There are numerous devices, the ones we have been working with are:
Particle Counter : Measures the number of particles floating in a sample of air. This is done by pumping a specific amount of air through a chamber where reflected laser light is used to count the particles into ranges. Typical sizes are 0.3, 0.5, 1.0, 3.0, 5.0, and 10.0 µm.
pH Meter : Measures how acidic or basic a liquid sample is. This is accomplished by a technician inserting a probe directly into a sample.
Conductivity Meter : Similar to the pH Meter but measures how well a liquid conducts electricity. The device electronics are the same as the pH Meter however there is a different probe that the technician uses to perform the measurement.
Balance : Measures compounds as well as animals.
As one example — what is a particle counter flush and why is it important to the overall drug quality assurance process?
The flush is necessary to purge the airway inside the particle counter of any stray particles that may have accumulated since the last time the device was used. This is necessary to make certain that only the particles that are present in the immediate area are counted when the sample is run. Note that in our system when a flush is run we provide the number of particles that were counted in the same manner as we would in a regular sample.
Why is Phizzle’s solution the first to focus specifically on disparate devices?
Our goal is to provide a user experience that is as standard as possible regardless of the device that is being used. In Pharma, technicians deal with disparate devices every single day to meet FDA data requirements. No solution would be complete unless it harmonized disparate device data.
What should technology companies looking to enter the pharmaceutical manufacturing space understand about these instruments? Why are they so unique?
In the case of particle counters —the main instruments we have been working with — they essentially do the same thing and give a similar report. The challenge is to get them to behave exactly the same in a repeatable way through normal operation and more importantly through edge case and edge of edge cases.
For example: suppose a sample is started remotely on a particle counter and in the middle of the sample, the ethernet cable that connects the particle counter to our edge device is removed. Then, after the sample finishes, the device is reconnected. We must be able to determine if the sample that we started finished or was aborted. Furthermore, it could have been stopped and restarted which also must be detected on re-connection. Other edge cases involve swapping instruments from one device to another, isolating our edge device from the network, etc…
Each of these particle counters have different remote control capabilities and oftentimes we need to work multiple interfaces to get the data we need. As another example, one manufacturer does not provide the current time on the Modbus interface (which is our standard interface for particle counters) however it is available via a Telnet interface.
Where do you see drug production processes that rely on these devices in 5-10 years?
The next generation of devices will expose more of their internal control, monitoring and reporting to external automation systems. With these enhancements the control systems will be able to better monitor the processes and environment resulting in higher quality, higher yield, and lower production costs.
Mike answered a key question for the IoT industry: what does it take to succeed as a 3rd-party technology provider with Fortune 100 Pharma? Watch his talk here.