Dr. Mike Schäfers from West Pharmaceutical Services, Inc., explains important considerations when sterilizing injectable components.
Injectable drugs have been around for several hundred years, and very likely originated from the use of weapons—such as blowpipes and poison-tipped darts—that brought various substances into the human body by piercing the skin. As early as the 17th century, various persons were given credit for having invented the syringe.
Today, however, injectable drugs have grown and expanded in its use. Injection drugs are favored in many medical settings for its increased (and rapid) effects—as it goes straight into the blood—and its efficiency (since smaller amounts of a drug are needed).
Despite these advantages, there are also disadvantages to this method—the foremost of these being the increased risk of infection.
Dr. Mike Schäfers, Vice President, Global Marketing, Pharmaceutical Packaging Systems, at West Pharmaceutical Services, Inc., explained the risk related to injectables that are not properly sterilized: “Injectables are injected—they are put into the human body directly, while pills go through the gastrointestinal system (which knows how to deal with bacteria). If you have bioburden or endotoxin contamination in injectables, it goes right into your bloodstream and can potentially kill a patient.”
To counter this risk, quality standards have been put in place to ensure any single injectable is properly sterilized through aseptic processing and is safe for use.
Components and containers are essential parts of each injectable. For components used for injectables, steam sterilization has been found to be optimal for West Pharmaceuticals and Daikyo Seiko, Ltd.
“Companies have used gamma irradiation on components in the past for sterilization,” said Schäfers. “But the downside is that gamma irradiation can affect the composition of the rubber, which (in the worst case) leads to leachables coming out of the rubber component and getting into the product.”
With steam sterilization, the effects of the sterilization is much milder, according to Schäfers.
Schäfers also explained the importance of quality. “In today’s environment, it’s extremely important that neither the final drug product nor the components used have any defects,” he said.
West utilizes a camera inspection system, which sorts out aesthetic and functional defects, as well as anything pertaining to contamination. While endotoxins, bioburden contamination, and particles are removed during appropriate and validated washing and steam sterilization processes, PPM-based specifications on functional and cosmetic defects are achieved through automated camera inspection processes.
According to Schäfers, there are four main trends in packaging components:
- The need for higher quality
- Focus on biopharmaceutical and pharmaceutical industry core competencies and the need for companies to outsource
- Total cost of ownership
- Increasing importance of components as part of a combination product
Although some companies are able to sterilize the injectable drug components efficiently and in a cost-effective manner in-house, many companies cannot.
“There are many companies that utilize sterilization as part of their processes, but there are also many that decide not to do component processing and outsource it to manufacturers like West and Daikyo,” said Schäfers. According to Schäfers, there are a lot of capital expenditures related to sterilizing components, such as maintaining cleanrooms, acquiring the proper washing machines, and then assessing the effectiveness of your sterilization through validations. Furthermore, for companies that do not need to sterilize components on a large scale, having their own sterilization equipment might be less cost-efficient than outsourcing.
When asked about biopharmaceutical and pharmaceutical manufacturing trends, Schäfers said, “More and more, pharma and biotech companies look to streamline their processes and outsource.”
West recently launched Daikyo RUV® (ready-to-use/validated components), which is the newest offering from West’s partnership with Daikyo. The components are manufactured at Daikyo facilities in Japan using clean, high-quality elastomer formulations and are then washed, inspected, and sterilized—with the intention of helping pharmaceutical companies reduce their manufacturing footprint while meeting their demand for virtually defect-free, clean, and sterilized components.
This article can also be found in the November/December 2015 edition.