How to Increase Productivity with Single-Use Fluidic Systems: Fundamentals for Biopharmaceutical Applications

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Hosted by: Eric Nofziger - Global Category Manager - Fluidics  |   Mike Knapp - Global Product Manager - Fluidics

Time: 35 mins presentation, 25 mins Q&A – 1-hour total

Overview

Increased availability of therapies for rare diseases alongside newfound societal demands, like the ageing population, has pushed the global biopharmaceuticals industry to expand at an extraordinary rate. Biopharmaceuticals offer highly effective action against illnesses that were once considered untreatable, with fewer side effects and the potential for an actual cure.

To meet this rising demand from existing and developing markets, a greater diversity of drugs needs to be produced on a global scale, while balancing increased scrutiny from the public and regulatory authorities. Today, biopharma production facilities face unprecedented component supply risk for production.

If you are involved in drugs and therapeutics production, you will recognize both the need for improved efficiency and the challenges presented by regulatory, legal and logistical limitations. However, now that the technology is coming into maturity, there is potential for easier transition to Single-Use Technology (SUT) and an increased scope for its implementation.

Masterflex® and Cole-Parmer® have developed a range of solutions that illustrate the fundamentals of Single-Use Technology and enable participants to make informed decisions when selecting equipment for their next process.

In this webinar you will learn how to:

  • Improve production capabilities, reducing operational costs and enhancing product safety
  • Mitigate risks associated with cleaning procedures
  • Select the appropriate Single-Use Technology for your unique process

Meet the presenters

Eric specializes in pump and transfer tubing Eric Nofziger – Global Category Manager - Fluidics
Eric specializes in pump and transfer tubing for the pharmaceutical, biotech, and microfluidic industries. Eric has spent 15 years with Cole-Parmer expanding the company’s global fluidics portfolio via product development, line extensions, equipment manufacturing, joint venture and acquisitions.

Mike is responsible for the commercial development of single-use instrumentation and equipment Mike Knapp - Global Product Manager – Fluidics
Mike is responsible for the commercial development of single-use instrumentation and equipment. Most recently, Mike was instrumental in expanding the Masterflex® product line with the Masterflex Single-Use Gamma Irradiated Sampling Bottle Assemblies. His prior experience includes 15 years in product management of broadband wireless technology and 7 years in nuclear propulsion operations and power generation.



Webinar Q&A

What is the internal diameter of the free tubing?

A representative will contact you regarding your free box of Masterflex® Puri-Flex™ pump tubing.

In commercial processing, how/by what means are batch failures typically detected—and how quickly?

The means by which a batch failure is detected depends on the type of failure. For example, equipment failure is often more noticeable than cross-contamination as it can result in tube rupture, cease of flow, or other immediately visible indicators. However, batch failure attributed to cross-contamination may not be seen until batch quality analysis has been done in the lab which can take some time. Either case would benefit from some automation such as pump monitoring from MasterflexLive® or prefabricated tube assemblies to ensure fewer points of potential
contamination.

PendoTECH® – Are those in-line sensors?

Yes, all the PendoTECH pressure and temperature sensors are in-line sensors intended for one-time usage. They may be autoclaved one time but the autoclave cleaning procedure would need to be validated.

PendoTECH – Is the flow sensor single use?

The flow sensors presented in this webinar were Masterflex single use which are intended for one-time use, the Levitronix ultrasonic sensors which are also one-time use, and the Masterflex ultrasonic sensor which is noninvasive and reusable without the need to clean it. Although these devices are intended to be disposable, they are accurate and durable for repeated use. For recommendations on repeat sterilizations, speak to our Application Specialists.

PendoTECH – Does this unit have Ethernet connections and do you have an SDK to add code?

No, the PMAT and PMAT-plus monitors do not have Ethernet connections and do not have software development kits to add or modify code.

Ancillary slide – Unit analog inputs; resolution and update times?

The 33502-01 Masterflex Ultrasonic Controller takes a 4-20 mA input from one 33501-XX series Ultrasonic flow sensor and provides a 4-20 mA output to any Masterflex pump. The signal is continuous analog.

What purpose does the flow controller serve if pump can do this?

Manual pump control is achieved be setting an rpm that have been calibrated to a desired flow rate. Over time, tubing and flow path conditions change and therefore pump rpm must be adjusted to maintain a constant flow rate. Normally, this is done by periodically running a calibration with the pump and system to determine the new pump rpm to set to achieve the same flow rate. With the ultrasonic sensor flow controller, the desired flow rate needs to be entered via the controller touch screen just once. The controller will speed up or slow down the pump rpm as needed to maintain the desired flow rate as system conditions change.

What are the considerations for invasive vs noninvasive solutions?

It really depends on your specific needs. Noninvasive solutions typically have higher start-up costs but lower operating costs than invasive, one-time use, solutions. Often the disposable options are less sophisticated and easier to apply to a new application. So each application needs to be evaluated by the long-term anticipated usage.

What is the best way to determine the wetted material?

ColeParmer.com offers one of the most popular chemical compatibility charts on the web and we also have world-class application assistance to customize your solution correctly. Calling our technical team to assist is highly recommended.

Can the ultrasonic sensor be used with opaque tubing?

Yes, its method of measurement is based on sound which is unaffected by tubing opacity. The sensors will work on most tubing types. Things to avoid would be workflows with air pockets or tubing with metallic braiding.

What are the sterility options for the single-use sensors?

Most sensors can be autoclaved at least once, but one should verify that the sensor of choice withstands the autoclave cleaning procedure they use. PVDF is gamma stable while PFA is not.