Standard

ISPE ISPE Good Practice Guide: Single-Use Technology

Nov 2018 Published

Note: This standard has a new edition: ISPE ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms

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Abstract

It is recognized that innovation and the fast evolution of SUT leads to a continuous expansion of available products. ISPE Good Practice Guide: Single-Use Technology intends to capture the current technology, the components, and how they are designed into processes. The information presented is useful in the following applications: Liquid or semisolid storage and transfer Cell propagation and production of bulk biologics Mixing of powders and liquids Filtration and centrifugation Heat transfer Chromatography Fill/finish

Document information

Standard from ISPE
Published: 1 November 2018
Version: 0
Document type: IS
ISBN:

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Version history History (45)

ISPE ISPE Good Practice Guide: Control Strategy Development for Continuous Manufacturing of Oral Solid Dosage Forms

ISPE ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems

ISPE ISPE Good Practice Guide: Validation 4.0

ISPE ISPE Good Practice Guide: Digital Validation

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ISPE ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Storage and Distribution Systems

ISPE ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC) Second Edition

ISPE ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations

ISPE ISPE Good Practice Guide: Process Gases, Second Edition

ISPE ISPE Good Practice Guide: Containment for Potent Compounds

ISPE ISPE Good Practice Guide: Membrane-Based Water Injection Systems

ISPE ISPE Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms

ISPE ISPE Good Practice Guide: Controlled Temperature Chambers Commissioning and Qualification Mapping and Monitoring

ISPE ISPE Good Practice Guide: Good Engineering Practice, Second Edition

ISPE ISPE Good Practice Guide: Maintenance

ISPE ISPE Good Practice Guide: Equipment Reliability

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ISPE ISPE Good Practice Guide: HVAC and Process Equipment Air Filters

ISPE ISPE Good Practice Guide: Asset Management

ISPE ISPE Good Practice Guide: Process Validation