CL3 Laboratories – A Hot Topic For Inspections
As the industry falls under ever closer scrutiny by inspectors, the demands on Lab Managers to provide evidentiary proof of containment is increasing, and not just for annual inspections.
Containment laboratories are inspected for integrity every year, but what happens in between annual inspections? This is the question laboratory managers are increasingly being asked by HSE Inspectors and is a hot topic.
There is a duty for laboratory staff to be able to identify potential leaks in the room fabric whenever these occur. Major leaks may show up as visible dust trails, but what happens if dust trails are not clear? Is there a procedure that will identify if there is a leak path or if any remedial works have been carried out satisfactorily? A CHTS efficacy study will not only enable you to establish a satisfactory SOP, but will also identify areas that require additional training to meet HSE requirements.
Providing a simple smoke pencil kit and certified training in its use will help you meet your statutory duties, provide evidence of planning and competence to the HSE and avoid the need to call in an external provider for every small leak path. A small amount spent on training now could save a large amount in enforced action later.
It is a fundamental requirement that containment level 3 laboratories can be effectively fumigated in the event of an emergency without entering the room. Therefore external inspectors/ auditors are demanding to evidence of fumigation efficacy in order to meet compliance or insurance requirements.
Carrying out an efficacy study will confirm whether your laboratory can be effectively fumigated without the need to wait for results back from the incubation of BIs. Do you have evidence of the fumigation efficacy of your lab? Now is the time to review how effective your fumigation protocols are.