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Single-Unit Drug Technology's Impact on Contamination and Traceability

Posted by: Steve Rau on 10/14/20 9:32 AM

In a summer 2020 article published on pharmamanufacturing.com, Senior Editor Meagan Parrish offers an analysis of single use technologies in pharma, providing rationale for their popularity in the market and offering a projection of continued success. 

According to the article, “pharma is turning to one-and-done equipment to reduce manufacturing risk, time and costs, while boosting needed flexibility for the production of next generation therapeutics. In response, vendors have continued to innovate SUT [single-use technology] solutions that improve productivity throughout all areas of manufacturing — from sample testing to tracing products after they've been shipped out the door." 

As a CDMO specializing in single-use drug delivery technologies, it’s great to see the market trending toward our specialty areas. The article, “Product Focus: The surge of single use,” outlines several key drivers for the current and projected success of single-use technologies. They include reducing the risk of contamination and aiding in track and trace efforts. 

Single-use drug delivery demonstration

Single-Use Drug Delivery Technologies Reduce Contamination Risk

While Parrish’s article references the frequent in-process sampling for cell and gene therapy production, making single-unit technologies an attractive option for reducing risk of contamination and reducing volume loss overall, this is just the tip of the contamination risk reduction iceberg. 

From the ground up, the design of single-unit drug delivery systems supports reduced contamination. From the individual packaging, where the drug is only exposed to the environment at the point of application, to the near-endless opportunities to build advanced materials into the design, lowered contamination risk is practically a natural byproduct of single-use drug delivery systems. 

Single-Use Drug Delivery Technologies Aid Track and Trace Efforts

In the article, Parrish explains, “Single-use technologies can also be leveraged to overcome challenges related to track and trace, which continues to be a major focus for pharma.” 

Here at Tapemark, our track and trace capabilities meet compliance requirements and provide our clients with insights into the supply chain. 

What is Track and Trace? 

Track and trace is a government law that was enacted in 2013 and was implemented across the US in November 2018. It’s a system that allows industry to electronically track a specific package of pharmaceutical product all the way from its manufacturer through its packaging and its distribution, even down to the pharmacy where the prescription is filled. 

At Tapemark, we've acquired the systems, equipment, expert partners, and put into place the processes for this level of track and trace and serialization in pharmaceutical products. Industry as a whole has been slow to get started on track and trace, but our investment ensures we can provide complete track and trace services to our clients and places Tapemark on the forefront of CDMOs in this space. 

To learn about the importance of track and trace, watch this video featuring a Process Engineer at Tapemark: 

A you saw in the video, if you’re producing individual doses, you can put a unique serial number on each dose. This, combined with a unique serial number on each carton that holds the drug, all the way up to the shipping case and pallet, makes it possible to track the entirety of a shipment on a dose by dose basis. 

What is a Unit-Dose System? 

Unit-dose systems are drug delivery systems that contain a single dose. They are packaged, distributed, and administered in single dose units. Each unit contains a predetermined amount of drug(s) that constitute a single dose. 

Single-unit or unit-dose drug delivery technologies provide a whole host of benefits, to the patient, provider, and pharmaceutical company. If you’re interested in developing a drug for single-unit delivery, get in touch with the experts at Tapemark.

Looking to discuss your project with someone well-versed in your specific  focus area? Talk to an Expert

Topics: Serialization, Unit Dose Semi Solid, Equipment & Facilities

Steve Rau

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