New Draft Recommendation on 
“Isolators used for aseptic processing 
and sterility testing“

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This was soon followed at the end of 1999 by a new draft "Revised draft submitted to Committee PE 004-1" but which was withdrawn again in February 2000 owing to considerable objections by the industry.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.

1. Document history
2. Introduction
3. Purpose
4. Scope
5. Definitions / Glossary
6. Principles related to the selection and use of gassed isolators
7. Detailed points to be considered for the implementation of the principles for gassed isolators
8. Revision history

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:

• Principles related to the selection and use of gassed isolators
• Training
• Materials
• Sporicidal treatment (very detailed)
• The prevention of recontamination (very detailed)

As an example the chapter on sporicidal treatment is to be shown with some of its own headlines in somewhat greater detail.

Requirements

• The substance for the gas sterilization is to be sporicidal
• The correct identity and composition of the substance used for gaseous sterilization is to be ensured
• It is not to be assumed that all gas generators are the same
• Staff should understand how the gas generators work
• Critical parameters are to be identified and recorded throughout the entire process
• Measuring instruments are to be calibrated
• It is to be ensured that all critical parameters achieve the specifications defined during validation
• All inlet and outlet filters are to come into contact with the gas during gassing. Air for rinsing the gas should be sterile filtered
• The isolator is to be cleaned before gassing
• The cooling zone of the integrated sterilization tunnel is to be sterilizable
• Before the isolator is released for production it is to be checked that the gassing cycle is adhered to
• Process parameters should be recorded
• The design, the development and the validation of the gassing process should include all relevant aspects, e.g. methods of gas distribution, lethality rates, calibration, protocols, etc.
• The requirements for the requalification and the interpretation of the results are to be defined prospectively

The draft can be downloaded at http://www.picscheme.org/pubs/PICSIsolatortechnologyPE004-1.pdf

Author: Dr. Andreas Mangel, CONCEPT HEIDELBERG