Editorial | Open Access | Published 16th July 2024
GUEST EDITORIAL : Is wet the new dry?
Author : Alan G Heavey
Consultant Sterilizing Engineer
Director, Sterilization Solutions Ltd.
Management Committee Member of the Pharmaceutical & Healthcare Sciences Society (PHSS).
During a recent ‘chat’ on wet loads in autoclaves, someone said to me, “Wet is the new dry”!
Think about that; it’s as though the norm is now to expect a wet load, rather than a dry one. It’s like saying, ‘When is a hole not a hole? When it’s a pothole!’ We have so many potholes in our roads now that they have become the ‘new norm’. That’s like wet loads in autoclaves for many, it’s now the new norm…..
When I first entered the world of sterilization and autoclaves back in the late 1970’s, the expectation was for porous/hardware loads to be placed into an autoclave chamber dry and to come out both sterile and dry; simples! A wet load was unusual and indicated a problem that needed fixing.
Nowadays, during my global travels, I meet with many in industry who struggle with this issue; consequently pharmaceutical and biotech companies have adopted a principle of creating overly long autoclave cycles to try and achieve a dry sterile load.
It would be fair to say that some autoclave cycles can be overly long due to ineffective and inefficient air removal stages, but to add excessive ‘drying’ stages, ‘overly long’ becomes ‘incredibly lengthy’! Where a classic UK style porous/hardware load, 121°C overkill cycle, could and should take only 1.5 hours, I have often seen 4.5 hour autoclave cycles in operation. How can that be acceptable? Where is the good business sense in terms of time, energy and cost, as well as reducing the overall capacity of the autoclave? Further, even with lengthy cycles, if a wet load occurs the cycle has in fact failed causing further delays and frustration. Apart from inefficiency, in an age of drug shortages surely this situation should be resolved?
If you read my last ‘story’ about wet loads (https://www.ejpps.online/post/vol25-4-wet-loads-a- phenomenon-or-by-design) you will see that I identified all the possibilities of wet load creation, starting from steam generation through to load configuration and packaging, as well as within the design and operation of the autoclave. As highlighted in that article I recommended the need for a move to bring together those involved in the design and installation of Pure Steam generation and distribution systems, autoclave design and functionality, load equipment, and sterile barrier packaging for the specific purpose of steam sterilization; all of this in order to produce dry sterile products in the most efficient and reproducible way possible.
Isn’t it in all our best interests to shift the norm from wet loads to dry loads?
Are there any pharmaceutical companies out there who want to enhance their production
capability, without the risk of cycle failure, non-sterility, burdensome cycle times and
potentially drug shortages and recalls?
What about autoclave manufacturers; are there any interested in debating this subject?
How about the suppliers of load packaging materials? Surely they have an interest in
ensuring the components placed inside their packaging can be easily autoclaved, resulting in
dry, sterile loads in a timely manner, i.e. without the need for overly long ‘air wave pulsing’
drying stages? Why do we need 4 plus hour cycles if we can reproducibly attain dry and
sterile loads in 1.5 hour ones?
Of course, this is only my view of the current situation in our industry. What are your thoughts?
Is there someone interested in hosting a forum where interested parties could meet and debate the
current situation of wet loads in autoclaves?
As I said at the end of my last article; “Thank you for reading this story – I hope you have found it
interesting and helpful. Maybe it’s time we went on an adventure…..”
Is now the right time?
If you are a company who is currently struggling with wet loads in autoclaves and would like to
discuss this confidentially, to determine how to address your specific issue, please get in touch.
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