Disposables COP E-Letters

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E-Letters

E-Letters are topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (COPs). The content for E-Letters is submitted by professionals working in the pharmaceutical industry and is a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems.

*COPs are now an ISPE Member-only benefit, therefore some E-Letter content can be accessed only if you are an ISPE Member. Join ISPE today to continue accessing all E-Letter content and other valuable resources that will assist you in being more effective at your job. 

January 2013

ISPE to Develop Guide on Single Use Technologies
The ISPE Disposables COP is planning on developing a Disposables Single Use Good Practice Guide that will cover all aspects of using disposable equipment and help standardize the use of disposables technologies between vendors and their clients. More. ( 139 KB)

Conference to Feature Discussions on Disposables
The use of disposables has been promoted a lot recently, but do they deliver what they propose? The Aseptic education track at the ISPE Aseptic Conference, to be held 4 – 5 March 2013 in Baltimore, Maryland, USA, will look at opportunities, limitations, and trends in disposable technologies. More.

Environmental and Financial Benefits of Single Use Technology
A Knowledge Brief highlights the options available when considering single use products and what financial advantages can result. Overall use of the products is covered, with a focus on handling of the products after use. More.

Standardization of Single Use Components’ Extractable Studies for Industry
Authors of an article in the May/June 2012 issue of Pharmaceutical Engineering recommends the formation of a standard(s) for extractables studies conducted on single use systems. More.

October 2011

Disposables in Bioprocessing
An article by the ISPE Disposables Community of Practice (COP) provides highlights from the discussion on disposables in the draft ISPE Guide: Biopharmaceutical Process Development and Manufacturing, currently under development. More. ( 76 KB)

Disposables Focus of ISPE 2011 Annual Meeting Education Sessions
The Disposables COP will be presenting the following education sessions at the ISPE 2011 Annual Meeting in Grapevine, TX, USA:

  • Current Trends in Disposables Applications
    (Tuesday, 8 November)
  • Disposables – Early Phase/Clinical Manufacturing Approach Utilization Disposable Application
    (Wednesday, 9 November)
    In these circumstances, disposable technologies may have a greater application for high throughput and low cost clinical screening of potential drug candidates. There are a number of issues that need to be resolved for Phase 0/1 production. This seminar will address compatibility issues, component interchangeability, supply chain risk, integrity of disposable systems and environmental monitoring challenges; advances in technologies for downstream processing; and development of a combined roadmap for successful implementation from phase one to commercial manufacturing.

Disposables Community Seeks Volunteers
The Disposables COP is seeking Subcommittee Members for the Member Relations Subcommittee, which will focus on the dissemination of information about the Disposables COP both internally to ISPE members, as well as to other organizations. Please visit the Disposables COP site for more information.


January 2009

Developing Best Practices for Disposables: Current Industry Status
The current lack of best practices for the implementation of single use manufacturing technologies in pharmaceutical and biopharmaceutical manufacturing is a recognized challenge within the industry. The ISPE Disposables Community of Practice (COP) recently set up three interest groups to work toward guidelines and best practices addressing multitude supply chain and validation concerns. Read more ( 16 KB) .

Disposable Powder Transfer Systems vs. Containment
Companies offer disposable powder transfer bags to be used to transfer powders (like potent API’s) to, e.g., disposable mixing bags. These mixing bags can be used, e.g., in the preparation of aqueous liquid drug product solution in a Class C area in a clinical production facility for sterile product manufacturing of parenterals. Can such disposable powder transfer systems be used in a C-area used for production of parenterals? Has anyone evaluated a similar situation? How contained are these transfer systems? These and other questions have generated a popular discussion thread on the Disposables COP site. Read more.

Tampa Conference Seminar to Focus on Assessing the Impact of Disposables
The ISPE Tampa Conference (2-5 March 2009) will feature the seminar, “Assessing the Impact of Disposables: Achieving Operational Excellence, Minimizing Waste.” It examines how to assess the impact of disposables for operational effectiveness by applying lean manufacturing concepts and applying cost modeling and process simulation. Based on end-user case studies the seminar also will examine effective procurement strategies for disposables, linking decision-making to engineering, validation, and best practices for waste management of disposables.


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