Cleanrooms have been part of Life Science manufacturing for a long time, for example a device, pharmaceutical or a pharmacy clean room all have specific design requirements to make sure that they add value. As cleanrooms have evolved in parallel with the manufacturing processes and techniques themselves, it is difficult to evaluate in isolation, just how effective they are.
Would there be any net benefit if we could take an existing, developed process that is rigorously monitored, where environmental control is vital and take that process out of a lab and into a cleanroom?
Recently I worked on the design and construction of a cleanroom for an internationally recognized IVF facility. Typically these facilities operate out of standard laboratories. The fertilization is conducted in a Biosafety Cabinet or Laminar Flow Hood and the embryo developed in special temperature controlled incubators. The transfer of the embryo is performed in a standard day-procedure room.
As you can imagine, a human embryo is a fragile object. It has no protection against any type of contaminant and has evolved to exist in an almost perfectly controlled environment. It makes sense that if an embryo is developed outside this environment, that you control the artificial environment as tightly as you can. What better environment than a well-designed cleanroom!
The new facility was designed to have the fertilization and growth of the embryo in an ISO 7 environment and the actual implantation of the embryo in an ISO 8 environment.
Did the cleanroom have any real effect?
The reputation of an IVF facility hangs on their pregnancy success rates. Did the switch to a cleanroom see their pregnancy success rates skyrocket? Of course not. There are a million reasons why an embryo will be created, survive the implantation, or result in a live birth (the defining factor for a pregnancy rate), or not. Add to this that couples utilize IVF usually because there is an underlying problem and the problem is not always solvable by IVF.
Initially the rates were much the same as they were at their old facility. As time passed they started to see a slight upward trend, but more importantly they noted that the variability of the pregnancy success rates over time had reduced significantly.
As the staff got used to working in a cleanroom environment and adapted to the new work practices, the upward trend continued. Although significantly reduced, there still was a degree of variability but this variability now started to display trends and patterns.
By controlling the environment the background noise was removed and other critical factors became apparent and could now be properly monitored and evaluated:
- Room and equipment cleanliness and maintenance;
- Consumable quality, and;
- Operator technique.
This meant that the facility staff could be more responsive to issues as they arose and the perfection of their technique became more imperative.
The success of this facility is a reminder of why controlling your environment is important.
Taking a process that relies heavily on environmental control and exposing it to modern cleanroom technology enables us to see it in an entirely different light.