Language:
    • Available Formats
    • Options
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $128.00
    • Add to Cart
    • Printed Edition + PDF
    • Immediate download
    • $183.00
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

ISO 13408-6:2005 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of isolator systems used for aseptic processing of health care products. ISO 13408-6:2005 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials. ISO 13408-6:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.
 

Document History

  1. ISO 13408-6:2021


    Aseptic processing of health care products - Part 6: Isolator systems

    • Most Recent
  2. ISO 13408-6:2005

    👀currently
    viewing


    Aseptic processing of health care products - Part 6: Isolator systems

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. ISO 13408-6:2005/Amd1:2013


    - Amendment 1