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The supply of sterile pharmaceutical closures into a filling line is an essential element of the production of parenteral drug products. In addition to sterilizable bags, West offers closures in aseptic transfer bags – referred to as “port bags” or “ported bags.” Port bags contain a “beta” port that is attached to the actual bag (Figure 1).
Courtesy of Sartorius AG
Figure 1: SSB Biosafe® bag for steam sterilization with rubber closures inside;
the beta port is the round part.
The beta port connects to an alpha port – the matching component on the filling line (Figure 2).
Courtesy of Sartorius AG
Figure 2: SSB Biosafe® portbag approaching SSB alpha port (stainless steel).
The principle of the alpha/beta port system is a “double-door” that is formed when the alpha and the beta parts are connected. This ensures that sterile closures are not exposed to any potentially contaminated areas, thus enabling the aseptic transfer (Figure 3). The theoretical risk of the "ring of concern" is eliminated by "chute/tube" features.
Courtesy of Sartorius AG
Figure 3: SSB Biosafe® portbag attached to the alpha port; the "double door" is opened and the closures are transferred with sterility.
West employs the two main portbag systems on the market: Biosafe® bags from Sartorius Stedim Biotech (SSB) (110 mm beta port diameter) and DPTE® BetaBags from GETINGE (GLC) (105 mm and 190 mm beta port diameter). Filled bags are offered in both ready-to-sterilize (RS) quality, and ready-to-use (RU) quality. RU sterilization is by either steam or gamma processing. For RU products, West has developed/validated packaging that ensures sterility of articles in port bags – so they can be used directly at a customer’s site without the need to develop a validated sterilization cycle. West’s focus is always on patient safety. Offering closures in formats that are safe and easy to use is well in line with that focus.
For further technical details please contact West's Technical Customer Service team.
Biosafe® is a registered trademark of Sartorius Stedim Aseptics S.A.
DPTE-BetaBag is a registered trademark of Getinge Group, its subsidiaries or affiliates.
The future is now for parenteral pharmaceutical and biopharmaceutical sterile production. Traditional high-volume automated aseptic filling suites are maintained by contract filling services. But what’s emerging? Parenteral pharmaceutical and biopharmaceutical industries have transitioned to fully enclosed, isolator/restricted access barrier (RAB) systems. These small, efficient systems offer cost savings and can reduce the potential for particulate and microbial ingress during aseptic fill/finish manufacturing by eliminating direct human contact in the filling environment.
Ensuring the sterility of sterile medicinal products has always been one of the key concerns of drug manufacturers, due to the dire health implications it could have on the patients, as well as the potential for costly product recalls. The importance of control strategies to ensure sterile drug products has also been reiterated by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and The European Medicines Agency (EMA) in their respective guidelines: <br /><ul><li>FDA – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice</li><li>EU GMP Annex 1 Manufacture of Sterile Medicinal Products</li></ul>
Sterilization processes are fundamental and critical in the manufacturing of sterile pharmaceutical products. According to the US Code of Federal Regulations, “Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use."<sup>1</sup> When considering elastomeric components, common methods for sterilizing include steam and gamma. This is where the sterilized components with Westar™ Ready to use (RU) and Westar™ Select RU quality levels come in. Westar™ RU and Westar™ Select RU quality level products are supplied ready to be used and help simplify and speed up the drug manufacturing process while maintaining high standards of quality and safety.
With the May 21, 2019 meeting to review the FDA draft guidance governing 503B compounding pharmacies, it has become evident that sterility of drugs produced at such facilities is a major focus of the U.S. Food and Drug Administration (FDA).<sup>1</sup> The meeting discussed the importance of qualifying container closure systems and was aimed at providing more context on what compounding pharmacies need to do.
Pharmaceutical closures used in aseptic environments must be introduced in a sterile state. The most common methods to sterilize rubber closures (e.g., stoppers) are autoclaving (saturated steam) and gamma irradiation. Both methods can influence chemical (e.g., extractables profile) and physical/functional properties (e.g., break-loose and extrusion forces). Therefore, it is important to choose the right method.
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