Maintaining a validated cleanroom is undoubtedly the best way to ensure the highest standards in your controlled environments. It demonstrates that your facility was designed to meet stringent compliance and that you also regularly test and monitor airborne particulate levels, surface particulate levels, viable microbial particulates, relative humidity, differential pressure, temperature and more.
Validated cleanrooms are certified according to the specific class of cleanliness based on the ISO (International Standards Organisation) scale. While initial cleanroom validation is a lifecycle process comprising five phases, operators must demonstrate continual compliance by abiding by an ISO testing schedule.
Maintaining the ISO standard of your cleanroom requires the enforcement of a rigorous decontamination routine, and, even when routine cleaning protocols are executed faultlessly, a major remedial decontamination exercise could occasionally be required.
Improvements in decontamination techniques and systems are consistently sought. Long gone are the days of manual cleaning alone with mops, buckets and wipes. There are many options open to cleanroom operators now and it is very important to select the right one for your particular needs.
In this article, we’ll take a look at the Minncare® Dry Fog 2 system. This is one of the most versatile options available that carries many advantages. In particular it achieves easily reproducible results that meet international pharma standards.
A closer look at the Minncare® Dry Fog 2 System
The Minncare Dry Fog 2 Cleanroom Bio-decontamination System has been distributed in the UK by Cherwell since 2014, and was officially launched by Mar Cor, a Cantel Medical Company.
The Dry Fog system is designed with three goals in mind: easy portability, cutting-edge sterilisation technology and to be fully customisable.
The Minncare® Dry Fog 2 system consists of:
- A multidirectional, interchangeable sterilant diffuser head that ensures penetration of Minncare into normally inaccessible areas.
- A stainless steel 316L decontaminant tank to hold the Minncare solution
- A sturdy, stainless steel trolley for easy portability
The Minncare system can be fully disassembled, and every part is autoclavable. In addition, the Dry Fog 2 system comes with a range of easy-to-use pre-made spreadsheet templates, which provide a handy guide to the amount of sterilant you’ll need to use for your cleanroom, which makes your decontamination process easy to set up and remember.
Advantages of using the Dry Fog 2 System
8 nozzle positions and vertical or horizontal spray diffusion
Wide area coverage
Portable system that requires no electricity
100% autoclavable design
Dry Fogging System
Stainless steel construction
Validated, compliant procedures
Using Minncare® Dry Fog 2 in your decontamination process
Once you’ve set up your Minncare Dry Fog 2 System, you’ll want to ensure you use it correctly to ensure proper levels of safety and efficiency, especially in order to see it perform as optimally as possible. Here is some valuable advice to bear in mind when using the Minncare Dry Fog 2 system:
Ensure that humidity is at optimal levels
Optimal Sporicidal Activity occurs between 70% and 80% relative humidity. Ensure that the cleanroom relative humidity is maintained below 80% to limit recondensation and to get optimal results from your decontamination.
Factor in the size of the area you plan to decontaminate
You can add or remove nozzles to adjust the Dry Fog 2 system to suit the size of your cleanroom. Before setup, don’t forget to consult the pre-made spreadsheet templates provided with your Minncare Dry Fog 2 system. This will help you to determine the water to Minncare sterilant ratios, based on various factors including the size of the decontamination area.
Prepare your cleanroom area
Remember, your HVAC system should be off for the duration of the fogging, and the area is to be completely clear of personnel until the cleanroom is safe for re-entry.
Allow sufficient time for fog dispersion
The vapours should take between 15 to 120 minutes to disperse, depending on the volume of sterilant used and the size of the room being decontaminated. The entire process, including venting, takes between two and five hours. The Dry Fog Vapour Detection System can be used to determine when vapour residuals are within safe levels (one part per million for Hydrogen Peroxide and ten parts per million for Acetic Acid). However, the maximum possible concentration of Acetic Acid when using Minncare Cold Sterilant under worst-case conditions, is 0.00002ml/cm2, and much lower under actual cleanroom conditions since Acetic Acid is never a solid.
No need for cleaning surfaces after fogging
Once the fogging process is finished, your cleanroom is completely sterile and safe – there is no measurable residue left, so there’s no need to clean or wipe down any surfaces.
The Minncare Dry Fog 2 System keeps decontamination simple and reliable, ensuring your validation and certification lifecycle processes are easily controlled and standards maintained.
If you’d like to know more about how Cherwell can help you, download our free guide to cleanroom decontaminations, in which we take a closer look at the decontamination process.