SK EN ISO 13408-4:2016

Status: Published
Gjuha: English
Faqe: 22
Publikuar: 2016-07-20
Regjistri Kombëtar:
Botim:

Standardet ndërkombëtare që kanë lidhje

This standard is identical to:
EN ISO 13408-4:2011
CEN/TC 204

Çmim: 25 €

Titulli Shqip

Trajtimi i proçesit të përpunimit antimikrobik ndaj produkteve të kujdesit për shëndetin- Pjesa 4: Teknologjitë e vendeve të pastrimit (ISO 13408-4:2005)

Titulli Anglisht

Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

Scope Shqip

Asnjë informacion i shtuar.

Scope Anglisht

ISO 13408-4:2005 specifies the general requirements for clean-in-place (CIP) processes applied to product contact surfaces of equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. ISO 13408-4:2005 is applicable to processes where cleaning agents are delivered to the internal surfaces of equipment designed to be compatible with CIP, which may come in contact with the product. ISO 13408-4:2005 is not applicable to processes where equipment is dismantled and cleaned in a washer. ISO 13408-4:2005 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain to particular national or regional jurisdictions.