GB/T 13339-1991
Abolished
T/SHPPA 009-2021
Active
Group standards
T/SHPPA 009-2021 Technical specifications for disposable systems in bioprocessing manufacturing
T/SHPPA 009-2021 Technical specifications for disposable systems in bioprocessing manufacturing
Price:
$ 20.00
Basic Information
Standard Code:
T/SHPPA 009-2021
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medicine, health, and labor protection
ICS Name:
Quality management and quality assurance
Publish Date:
2021-01-06
Implement Date:
2021-02-08
Scope
Scope: This document applies to the production and quality control of single-use systems in biotechnology processes; Main technical content: Single-use systems in biotechnology processes, also known as Single Use Technologies (SUT), are a process consumables solution, typically assembled from polymer material components to form a system or unit operation, used for a single or phased biotechnology process or pharmaceutical production activities. This document specifies the production and technical requirements of single-use systems in biotechnology processes, including storage systems, single-use aseptic sampling systems, and single-use filling systems, etc.
Development Information
Related Standards
GB/T 13340-1991
Abolished
GB/T 13340-1991 Methods for determination and calculation of quality grading rate of products
GB/T 13341-1991
Abolished
GB/T 13341-1991 Methods for determination and accounting of quality failure rate
GB/T 19004.3-1994
Abolished
GB/T 19004.3-1994 Quality management and quality system elements—Part 3:Guidelines for processed materials
GB/T 19004.2-1994
Abolished
GB/T 19004.2-1994 Quality management and quality system element—Part 2:Guidelines for services
GB/T 19000.4-1995
Abolished