Improve Productivity and Operational Efficiency with Single-Use Technology in Bioprocessing - The Science of Real Life

Presented by:
• Rob Martindaleo – Product Manager, EMEA, Masterflex^®

In this webinar you will:

• What SUT is and what it means for a typical production environment
• How SUT reduces the risk of cross-contamination
• Advantages of sourcing SUT from an approved supplier versus permanent process lines and sourcing and assembling your own single-use components

In many manufacturing environments, and especially in the biopharmaceutical market, there is a constant emphasis on making productivity improvements and streamlining everyday processes. To meet this rising demand from existing and developing markets, a greater diversity of drugs need 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 bioprocessing, you may find you are consistently asking yourself how you can gain more efficiency and enhance productivity in your process. It’s the common question asked by many companies that work to meet the daily challenges of this industry. One solution that companies are turning to is the implementation of single-use technology (SUT). It’s been gaining popularity over the years and is becoming the norm in many instances.

In this webinar, we will expand on what’s possible with SUT and then highlight practical ways it can make positive impacts on your workflow and bottom line.

Presenters

Rob Martindaleo – Product Manager, EMEA, Masterflex® 
Rob Martindale is the EMEA product manager for Masterflex, an Antylia Scientific company. Rob’s primary focus is introducing the steady stream of new innovative products into the marketplace. He assists our vast and experienced sales team as they provide customers with application solutions incorporating our Masterflex pumps, pump tubing and single-use technology. Rob has 20 years of experience working within manufacturing of medical devices. He began his career as a mechanical design engineer.

Questions & Answers from the live event

How long would you expect the delivery process to take from initial enquiry to delivery of SUT?

This depends on a few items. The primary delays come from: (1) Initial back and forth on the design and how long it takes to reach a final design, and (2) The components for the assembly and based upon what is stated in the Bill of Materials (BOM). If there is an item with a long lead time, we try to recommend an alternate item that Masterflex® may have on the shelf. Usually, it is a few weeks but can be longer if there are longer lead times on specific items.

Why are manufacturers and suppliers such as Masterflex, amongst others, better positioned to provide SUT than a pharmaceutical manufacturing company?

Overall, Masterflex has a very low threshold for an item to be considered an in-stock item. We have a very robust offering of tubing and fittings in our single-use portfolio, and we are not dependent on using one factory for our components, so we have several alternatives if the availability of a specific item is temporarily constrained.

At which point would you suggest a single-use assembly becomes too big for the manufacturing company to assemble themselves?

To date, we have not come across any assembly that is too large. We have had to break up an assembly to fit into multiple bags due to its size, but we were able to place all into double-bagged configurations for the gamma-irradiation process.

Where do you do the assembly work?

We have different options depending on what is being requested. Currently, we have assembly locations in the US and Europe.

Are your products compatible with other brands to reduce customers supply chain risks?

Yes, we have a large varying portfolio of products. With fittings and tubing, we are not aware of any instances where products are not able to fit together. If there are specific details that trigger this question and you would like to dive deeper, please reach out and we can set up a call.

How do you mitigate supply chain risks for your customers?

We approach the mitigation of risk at multiple levels. At the beginning of the process, we review the BOM and provide recommendations based upon stocking codes and lead times for the single-use components. After that, we can work on blanket orders to ensure the BOM components are in our staging facility to ensure that product will be available for timely delivery of finished assemblies.

What is the recommended maximum length for single-use tubing to dispense fluid between a vessel and filling line?

The depends on the system conditions. To best answer this question, we will need more details around chemical compatibility, flow rate, the ID of the tubing, the viscosity, the temperature of the product and ambient temperature, to name a few things. Please feel free to reach out to our application specialists to go through your specific application.

What is the size range for tubing and fittings?

For pump tubing, we have tubing from 0.13 mm ID to 19 mm ID. For transfer tubing, we have tubing from sub mm ID to multiple centimeters. We also have fittings to match.

What about the environmental impact of single use?

One needs to look at the complete process of what and how the tubing is being used. While single use does require the need for new assemblies to changing from lot to lot, the single- use assembly does not require continual cleaning/flushing of rigid pipes when changing batches. Also, with sterile single-use assemblies, the risk of a contaminated batch due to improperly cleaning the rigid pipe is removed, eliminating the potential of wasted product (time and materials).

What do you pay your assembly technicians?

Pay is dependent on location of the cleanroom location and market rate for experienced technicians in that area.

What solution do you have for the increased trash associated with SUT? Do you have a recycling option?

With single-use products, recycling is not normally possible due to the chemicals being transported through the tubing. Typically, the products are incinerated.

Currently there is so much capacity of SUT going to large COVID drug manufacturers, how does us "smaller fish" contend with these long lead times?

To help those non-vaccine customers, we have been focusing on blanket orders and understanding their needs to minimize the interruption of supply of product coming into their facilities.