By Adriana G. Lopes, Andrew Bown

Single-use expertise (SUT) is now on hand for all processing operations in the biopharmaceutical undefined. It has the capability to lessen capital expenses, increase plant throughput and decrease the danger of cross-contamination. even though, there aren't any transparent instructions to help the end-user on implementation of those applied sciences right into a tested, solid production perform (GMP) atmosphere. This guide is the 1st entire ebook of sensible concerns for every degree of the implementation means of SUT, and covers the choice, specification, layout and qualification of structures to fulfill end-user requirements.


Serving as an advent and sensible connection with this turning out to be sector of software in the biopharmaceutical undefined, this instruction manual presents:

  • An process for SUT implementation inside an end-users facility with examples for bioreactors, tangential-flow filtration and fill-finish systems;
  • SUT in the context of regulatory advice, comparable to ICH Q8, Q9, Q10 and GMP;
  • Strategy for standardisation of single-use bag structures and evaluation of extractables and leachables;
  • Specifications of person requisites and layout of particular SUT along procedure descriptions and stream diagrams;
  • Strategies and instruments to guage possibility with examples of probability tests acceptable to layout, processing and product caliber; and
  • Qualification procedure for various SUT types.


With the knowledge awarded during this e-book, engineers, researchers and pros curious about biopharmaceuticals may be higher ready to devise and make powerful judgements to layout and enforce SUT.

Show description

Read or Download Practical Guide to Single-Use Technology: Design and Implementation PDF

Best Manufacturing books

Making in America: From Innovation to Market (MIT Press)

The US is the area chief in innovation, yet the various cutting edge principles which are hatched in American start-ups, labs, and corporations turn out going overseas to arrive advertisement scale. Apple, the celebrity of innovation, locates its construction in China (yet nonetheless reaps so much of its gains within the United States).

Logistics Operations and Management: Concepts and Models

This ebook presents a complete evaluate of the way to strategically deal with the stream and garage of goods or fabrics from any aspect within the production method to patron success. themes coated contain vital instruments for strategic determination making, shipping, packaging, warehousing, retailing, purchaser prone and destiny tendencies.

Manufacturing for Export in the Developing World: Problems and Possibilities

Lately, a lot has been made up of the luck of constructing international locations, relatively in East Asia, that have completed monetary development by way of production items that are then exported to constructed economies. Case reviews of 5 nations discover severe power problems in holding the velocity of producing for export within the constructing nations, and indicates that there's no easy courting among import liberalization and production for export.

Instrumentation Reference Book, Fourth Edition

The self-discipline of instrumentation has grown substantially lately due to advances in sensor expertise and within the interconnectivity of sensors, desktops and keep watch over structures. This 4e of the Instrumentation Reference publication embraces the gear and platforms used to discover, song and shop information relating to actual, chemical, electric, thermal and mechanical homes of fabrics, structures and operations.

Extra info for Practical Guide to Single-Use Technology: Design and Implementation

Show sample text content

Rated 4.50 of 5 – based on 15 votes