How single-use systems became standardized.
Significant headway has been made in standardizing offerings and processes of single-use technologies—particularly since the early days of bioprocessing companies utilizing large-scale, food bag manufacturing lines in their pharmaceutical facilities.
The term ‘savings’ has also become inextricably linked with ‘single-use,’ leaving many companies with the notion that this technology has the lowest price tag in all circumstances. But that isn’t always the case.
“Although you do have this increase in operating costs due to the plastic disposables, there were huge savings in energy requirements and water,” said Jerry Martin, Pharmaceutical and Life Sciences Consultant to PMMI and Chairman Emeritus of the Bio-Process Systems Alliance, when describing the economics of single-use technologies. Comparatively, traditional stainless steel facilities have to endure costs related to cleaning and sterilizing their equipment.
Even in terms of an existing plant, companies utilizing single-use technologies are reducing:
- Energy requirements
- Carbon footprint
- Chemical agents (used to clean systems that later had to be disposed of)
“It [single-use systems] eliminated a lot of the downtime—the equipment that you’d have to break down, clean, and re-sterilize. That’s all time that you’re not making product. Whereas, with single-use, you can use it, take it out of the equipment, put another one in, and start working right away,” said Martin.
As a result, the driver for single-use slowly became economics (in addition to cleanliness and convenience).
Single-Use Implementation: New Facilities & Expansions vs. Existing Facilities
Some pharmaceutical professionals have expressed economic concerns with single-use technologies and their necessary machinery—specifically when installing new machinery at an existing facility (as compared to purchasing single-use technologies for a new facility).
“It’s rare,” Martin said in response. “There have been cases where people actually have taken out their stainless steel [machines] and replaced it with single-use. The best example of that is a company called Catalent. They built a contract manufacturing facility in Wisconsin, and they had a large stainless steel bioreactor and they actually decommissioned it and replaced it with a single-use bioreactor.
“In most cases, people are not—as of yet—taking out existing facilities.”
There is some discussion of taking out stainless steel machinery from existing facilities, as the machinery starts to age and (at some point) needs to be replaced. However, according to Martin, most of the applications of single-use have been at new facilities and expansions.
“There’s a huge savings for new facilities because the cost of the equipment is much less than stainless steel with all the piping and engineering,” said Martin. “Plus, because the single-use systems can be pre-assembled and pre-sterilized, you need less clean room space, and clean room space is very expensive to be put in. If you can cut the size of your clean room by three-quarters, for building a new factory, it’s much cheaper.”
Cleaning & Sterilizing Single-Use Technologies
In the past, one of the complaints of single-use technologies was the inconvenience to sterilize them. Some of the suppliers did not ship the single-use technologies pre-sterilized, which was a significant burden on the pharmaceutical companies receiving them—as many had reduced their clean room capacities.
“Some years ago that was true,” Martin said, “but not so much anymore.”
According to Martin, most single-use suppliers now supply single-use technologies pre-sterilized. In addition, with some encouragement from the FDA—who now seems to prefer single-use operations to traditional stainless steel—the market is swiftly changing.
“In stainless steel, the sterilization is being done by the individual pharmaceutical manufacturer. Each manufacturer has to validate their procedures to ensure they are effectively sterilizing the fluid path. That is something that the FDA has to look at very closely for every drug company.”
On the other hand, all of the single-use suppliers send their systems out to contract gamma irradiation facilities.
“There’s only a limited number of contract gamma irradiation facilities in the country, and they’re already registered with the FDA because most medical devices today are sterilized by gamma irradiation. . . . The FDA has much more confidence in the reliability of a gamma sterilization process, especially since there’s fewer facilities and they can oversee those facilities much more readily than having to check every single pharmaceutical plant. That’s where single-use is seen by the FDA as a more reliable, robust process.”
If companies are supplying the end user, most will send single-use systems out to gamma irradiation facilities.
“The only exception is if you, as a user, want to cherry pick your components, then you might also use a contract assembler that is just doing assembly. Then you are responsible to have that assembly go the sterilizer,” said Martin.
Most companies, according to Martin, are not doing it this way—as the industry seems to be turning to having all materials pre-sterilized from one of the major suppliers.
“Today, the concept of single-use has become well-accepted,” said Martin. “Where a lot of the attention is being placed now is to understand the supply chain and to establish a closer relationship with the supply chain itself.”
PMMI, The Association for Packaging and Processing Technologies, represents the voice of more than 700 North American manufacturers of equipment, components, and materials for processing and packaging.PMMI co-produces Pharma EXPO – Nov. 6-9, 2016 – with the International Society for Pharmaceutical Engineering (ISPE).