ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 5: STERILIZATION IN PLACE (ISO 13408-5:2006, IDT)
This Malaysian Standard specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control.
This Malaysian Standard applies to processes where sterilizing agents are delivered to the internal surfaces of equipment that can come in contact with the product.
This standard does not apply to processes where equipment is dismantled and delivered to a
sterilizer.
This standard does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular national or regional jurisdictions.
This standard does not specify requirements for development, validation and routine control of a
process for inactivating the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform e
Published
• (none) / (none) / (none)
PDF
26/01/2021
23
NSC 18 - Medical Devices and Facilities for Healthcare
