Holland Provides a Broad Range of Single Use Components for the Biopharmaceutical Industry
As a follow up to our last post on plastic vs. stainless fittings, today’s post will focus on the key driver that are causing afundamental shift in the pharmaceutical processing world. By understanding the benefits and alternatives single use provides to stainless, you’ll be better able to identify applications where single use makes sense for you.
To begin, while there are a plethora of micro factors driving that highlight the advantages and disadvantages of specific products, there are a few overarching considerations pushing companies to consider and design for single use. The issues we’ve identified as “macro” factors are as follows:
- Reduced upfront capital costs
- Reduced downtime
- Smaller facility footprint
- Increased flexibility
- Environmental considerations & Reduced utility costs
Let’s take a look at each of these a little more closely:
Reduced Capital Cost
Single use facilities by nature have a lot of plastic and not as much steel. That means no expensive stainless steel tanks and no contractors performing hundreds and hundreds of welds. Plastics bags replace expensive stainless tanks and flexible tubing with connectors replace piping. While there are continuing costs associated with single use, the initial amount of capital required to get a facility making drug is less.
One of the most time consuming tasks performed at a pharmaceutical manufacturing facility is cleaning and validating that cleaning. CIP, SIP, and autoclave cycles all take quite a bit of time and usually need to be performed after each production run. When a system is being cleaned, it is not making drugs, which impacts the total capacity of the facility. By going to pre-sterilized single use assemblies, equipment is discarded after each run and quickly replaced by new manifolds, reducing down time and increasing capacity.
The smaller footprint of single use facilities can be important for two reasons- it can mean that you can buy a smaller (cheaper) building, or it means you can fit more production equipment in your existing facility. Either way, improved titers yielded by modern technology are allowing us to use shrink process equipment and maximize productivity.
As a process engineer, can you imagine a facility where you didn’t have to worry about cross contamination? Closed modular single use systems make this a possibility. No longer do systems need to be tied or looped back to a central utility system. No longer to we have to validate cleaning procedures and have dedicated tanks or systems for each product. Single use systems allow us to run more products from fewer facilities.
Environmental Impact and Reduced Utility Costs
With single use systems, it should be no surprise that there is going to be a lot more trash generated. Doesn’t this have a much more deleterious affect on the environment than stainless systems? Not really- let us explain. Almost all single use components can be recycled or incinerated and used to regenerate heat for a building. Not only that, but plastics tend to be more environmentally friendly that caustic CIP chemicals. In fact, studies show that the most environmentally damaging thing a company does is have its employees drive to work. So if we’re going to be serious about saving the environment, we should focus on ride sharing and public transportation, not the pile of recyclable plastic by the dumpster.
Going along with that, now that we no longer need to CIP, we are able to drastically cut our WIFI consumption. This means we need to less heat to feed our WIFI stills. Most stills consume a tremendous amount of electrical energy and with energy costs in Illinois jumping between 10-20%, reducing energy consumption can be a huge cost savings.
So while there are many micro factors that drive people towards single use systems, it is the macro factors that still dominate managements decision to go one with or the other. The above is not to say that single use does not pose it’s own set of unique challenges, but rather to illustrate the key drivers in the industry today. Contact a Holland Sales Engineer today for more information on this topic.