The revision of Annex 1 is requiring a major effort from the life sciences industry; from ‘setting up new processes, to training staff, to managing non-compliance, the industry needs to adapt particularly to new requirements regarding contamination control strategy and the essential elements needed to develop a robust sterility assurance system. AM Instruments with Tim Sandle, a microbiologist, author and science journalist, known as one of the leading experts in the field:
‘The most significant change is in relation to equipment sterilisation when used for aseptic processing. The 2017 draft stated that critical surfaces with direct impact need to be sterilized (such as a filling manifold or stopper bowl); however, with the 2020 revision this now requires direct and indirect contact parts to be sterilized. This could present challenges to facilities with both isolators and RABS devices.
The Annex also specifies that each item sterilized needs be inspected for damage, packaging material integrity and moisture on removal from the autoclave. Any item found not to be fit for purpose, either damaged or where there is evidence of a ‘wet load’, should be removed from the manufacturing area and an investigation performed. On the subject of wet loads, this is the most worrying factor. When steam enters the autoclave chamber and contacts with the product, it is important that the steam collapses (condenses) on the product. This is in order for the heat to be released to the load. However, the formation of water must be discharged through condensate management or re-vaporized in order to prevent contamination of the product. Removal of the excess water is important to prevent insulation of the load from the steam’.