GMP News Nr. 131
12 September 2001
Draft Recommendation on
On June 12, 2001 PIC published a new draft on isolator technology. Like all PIC documents dealing with this subject, this document is also not binding for the industry but addresses inspectors belonging to the supervisory authority. However, the industry can see from these documents what areas the supervisory authorities will concentrate on in future inspections of isolator systems.
Historical background: A first attempt to define requirements for isolator technology was made by PIC in 1997 with the publication of the document PS/W 3/97 "Inspection of Isolator Technology". This was soon followed at the end of 1999 by a new draft "Revised draft submitted to Committee PE 004-1" but which was withdrawn again in February 2000 owing to considerable objections by the industry.
In April 2001 PIC embarked on a new attempt, which was published in June 2001as PE 004-1 Draft 3 for commenting by the industry. The deadline for comments expires at the end of September 2001.
Fundamental differences between the various versions:
While the 1999 draft described many aspects of isolator technology in great detail the structure of the new draft was considerably simplified. On only 6 pages (in the 1999 draft 20 pages) the fundamental requirements were briefly described.
Details on Item 7, particularly on decontamination and the prevention of recontamination are specified in an approximately 13-page appendix dealing especially with the following points:
As an example the chapter on sporicidal treatment is to be shown with some of its own headlines in somewhat greater detail.
The draft can be downloaded at http://www.picscheme.org/pubs/PICSIsolatortechnologyPE004-1.pdf
Author: Dr. Andreas Mangel, CONCEPT HEIDELBERG