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 elevate and maintain the level of excellence across the single-use industry.
Component Quality Test Matrices
For each single-use system subcomponent class — whether filter capsules, films and containers, tubing, and connectors and fittings — BPSA member manufacturers identified consensus quality tests. The matrices describe test methods in common language and list consensus reference documents along with testing frequenc...
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 (
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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 establish a guide to address the issue of disposing of single-use bioprocess components and systems. The purpose of this introductory guide is to address the following questions:
This guide provides information to help concerned professionals and companies better understand the issue of single-use bioprocess component and system disposal.
Options for Disposal
When disposing of a large-scale system, a company may be dealing with an assembly of ...
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 not widely understood in the pharmaceutical industry, which has historically relied on moist heat (steam) for sterilization of stainless steel bioprocess systems.
Under the auspices of The Society of the Plastics Industry, Inc. (SPI), the BPSA Technology Committee established a subcommittee to develop this guide to irradiation and sterilization of single-use bioprocess components and systems.
Scope, Purpose, and Backgrou...
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 market are 500-L to 2,000-L disposable bioreactors and cryogenic storage bags, further expanding the design space for single-use applications in biopharmaceutical manufacturing processes.
Over time, the biopharmaceutical industry’s level of comfort with single-use options has grown. Sales of disposable bags, containers, and tubing are increasing annually by 10–20%, according to a recent worldwide report surveying 187 biopharmaceutical manufacturers and contract manu...
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 to processes. But those are relative terms and depend on end-user requirements for proper interpretation. Simplicity is not an inherent characteristic of SUTs alone. At a contract manufacturer providing parenteral fill–finish services, end users (e.g., process engineers charged with technology transfer) must acknowledge that typically no appreciable amount of time will be allowed to design and subsequently optimize or develop a p...
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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 component. Ideally, processing methods and equipment are chosen early in the development lifecycle of a pharmaceutical product. The choice should be made by a dedicated team of scientists, quality assurance and/or regulatory affairs (QA/RA) representatives, and validation specialists working in partnership with component and system suppliers.
It is important first to understand the distinction between extractables and leachabl...
