May 2008 Supplement

Guide to Irradiation and Sterilization Validation of Single-Use Bioprocess Systems

Single-use bioprocess manufacturing systems increasingly are being implemented by the biopharmaceutical industry based on safety, time, and cost-reduction benefits. These disposable systems are used to process or contain fluids ranging from culture media, additives, and buffers, to bulk intermediates and final formulations. In many cases microbial control or sterility is required to ensure product purity and safety. Radiation sterilization is a common means of microbial control and sterilization applied to single-use systems. The standard methods for validating radiation sterilization are…

Integration of Disposable Technology

The use of single-use components in the biopharmaceutical industry is not new. For more than a decade, a range of disposables have been available and commonly used — plastic film bioprocessing containers, microbial sampling bags, encapsulated filters, sterile connection devices, tubing, flasks, roller bottles and hollow-fiber membrane systems, to name a few. What began as a handful of individual components is now evolving into a category of preassembled, sterilized, and validated integrated disposable systems. The latest innovations to hit the…

It’s Not Whether but Rather What and How to Implement

When considering integration of single-use technologies (SUTs or disposables) into a manufacturing process and facility, a number of criteria should be satisfied. These criteria govern both selection and implementation. Each criterion should be established by due diligence in which end-user requirements and the operation setting are considered carefully. Depending on a facility’s infrastructure and even a company’s business model, end users will define their criteria differently. Companies are driven to single-use technologies because of the simplicity and flexibility they impart…

Recommendations for Extractables and Leachables Testing

Figure 1: SARTORIUS STEDIM BIOTECH (WWW.SARTORIUS-STEDIM.COM) Determination of extractables and leachables for disposable manufacturing systems must be addressed as part of process validation when single-use technology is used. The idea that compounds leach into pharmaceutical formulations or process fluids (e.g., buffer solutions and bulk storage) from processing and storage materials is not new or even unique to plastics. All materials have extractables and potential leachables. When properly evaluated, these are easily addressed and rarely lead to disqualification of a disposable…

Complete BPSA Component Quality Test Matrices

LUIS CARLOS TORRES (WWW.ISTOCKPHOTO.COM) As one of its first initiatives, the BPSA Technology Committee conducted an initial review of referenced quality test methods and specifications currently applied to common components of single-use systems: filter capsules, films and containers, tubing, and connectors and fittings. Recognition of consensus quality test methods, referenced to established industry standards and regulatory bodies, can help guide users when making their selections and can facilitate qualification, validation, and use of single-use products. Ultimately they can serve to…

Guide to Disposal of Single-Use Bioprocess Systems

Single-use bioprocess systems can provide a range of environmental benefits beyond those of stainless steel systems. Although single-use systems may generate additional solid waste, benefits include reduction in the amount of water, chemicals, and energy required for cleaning and sanitizing as well as avoiding the labor-intensive cleaning processes required with stainless steel systems (1, 2). One of BPSA’s core activities is to educate users and develop guides on issues pertaining to single-use systems. The organization’s disposals subcommittee was chartered to…