How to Control Fungus in Cleanrooms

Fungal issues are significant in controlled environments. To ensure your cleaning agent will be effective against mold and yeast, follow this series.

Fungal contamination from mold and yeast are concerns for cleanrooms in any industry. Mold issues in particular have surfaced in cold rooms, door kick plates, incubators, and cleanroom startups in addition to the cleanrooms themselves.

One of the major concerns, outside of properly testing for and catching contamination, is finding an effective disinfectant. Not all disinfectants are effective against fungal spores; you might have to use a sporicidal agent to control fungi. Another issue is that fungus will develop a resistance to products, so you need to rotate at least two different ones that are equally effective.

When selecting a disinfectant, you need to take critical steps to ensure you choose an effective agent. Here is the first:

Gather all information and data.

Before you can test products or even choose them, you need all the information necessary to make your decision. Collect all the relevant and available information from the suppliers. The information you want includes:

  • • Technical data sheets
  • • MSDS
  • • Recommended directions for use
  • • Review all available testing on substrate compatibility, stability, and microbial efficacy
  • • Ensure these tests were performed in accordance with accepted standards (AOAC, ASTM, EN)
  • • Check that the product was manufactured according to local, state, and country regulations
  • • Certificate of manufacture/analysis
  • • Audit supplier’s change control policies to ensure you’re notified of any significant changes to the product
  • • Any other information you need to compare products and make the appropriate selection

Selecting a Disinfectant for your Cleanroom

There are numerous types of fungi that can grow in your cleanroom. Selecting the right disinfectant(s) depends on several processes. In part one, we discussed the different types of relevant data you want to collect. Here we will discuss testing disinfectants for efficacy.

Many factors influence the effectiveness of the active ingredients in biocides. Some of them include:

  • • Concentration
  • • Surface type
  • • Contact time
  • • pH
  • • Organic soil
  • • Bioburden
  • • Hardness of the water
  • • Temperature

The actives used against fungal spores will perform differently depending on the factors above. It is therefore necessary to perform in-house testing. For pharmaceutical environments in particular, a series of tests are necessary. Some agents that work against vegetative fungi aren’t effective against fungal spores. Here are three methods to consider.

  1. Suspension Tests:
    These tests work to determine the time necessary to reduce an acceptable amount of organisms. However, they do not address efficacy within various surface types. The microorganism is suspended in the appropriate dilution of the test disinfectant. This should be done at room temperature at selected time intervals. After neutralizing any remaining disinfectant from the sample, viable counts can be performed.
  2. Carrier Tests:
    Here is where you will test efficacy on hard surfaces. You use a carrier made of the type of surface(s) in your cleanroom (e.g. stainless steel) to test disinfection agents. Typical cleanroom surfaces include stainless steel, terrazzo flooring, epoxy, vinyl, lexan, and glass.
  3. Statistical Comparisons:
    This is an ongoing test comparing the frequency of isolation and the number of organisms isolated before and after disinfection. It’s important to carry these tests out throughout the year. You may find seasonal variations that alert you to facility or maintenance issues.

In the end, the disinfectant application process should be validated. If you need cleanroom validation or certification, or if you have questions about these processes, contact Gerbig Cleanrooms at 888-628-0056 or info@gerbig.com.

4 Mistakes that Kill the Strategic Direction of your Cleanroom Facility

Cleanroom managers have a lot on their plates. Initiating a strategic direction will help you reach your goals, but not if you make these mistakes.

Without a clear and accepted strategy for achievement, your organization can struggle to realize its goals. That is why it’s important to develop a directive for planning, resources, and day-to-day decisions. There are four common mistakes leaders make that obliterate strategic direction:

  1. Too focused on the now. We live in a world of instant gratification. We also tend to get caught up in the urgency of what is in front of us. Failure to see beyond the present will lead you to disconnect from your overall goals and objectives. Don’t let the immediacy of the next meeting, goal or report distract you from the big picture. Remain aware of where you want to go.
  2. Lack of sensibility. Your process is going to start with a written vision. On paper, it may look good, but if it isn’t pragmatic, it won’t move people to action. Your vision is important – it describes your intentions. However, you need to polish it off with direction to get people motivated.
  3. Disconnect between the top and the middle. It doesn’t matter how smart or reputable the leaders are in an organization – if you don’t get buy-in from the middle on your plan, it will fail. Part of what can sabotage a union amongst the staff is when leaders do what they like rather than what makes sense for strategic direction. Put your egos aside, and stay focused on the end game.
  4. Lack of review. Strategic direction demands constant review. You need to stay on top of what is working, what isn’t, what has changed, and the unexpected. Remember, you won’t snap your fingers and suddenly have success. This is meant to take some time. It needs shaping as you, your staff, and your company evolve.

You will identify strengths and weaknesses much easier if you keep an ongoing record of your progress. Note everything, even if it seems insignificant. You never know when two seemingly unrelated things will connect.

If it’s time for you to validate or certify your cleanroom, contact the experts at Gerbig Engineering Company. With thirty years of experience, we will help guide you to success. 888-628-0056; info@gerbig.com

Clean Bench Features: A Quick guide

With the variety of clean benches to choose from for cleanroom applications, this quick guide will point you in the right direction.

One piece of equipment many cleanroom managers have to consider is a clean bench. Depending on the purpose of the bench, more than one may be necessary. When it comes to clean benches, the options are numerous.

Clean benches and workstations generally use either HEPA or ULPA filtration systems. They provide workspaces for applications like conducting research or isolating a manufacturing process. They tend to come in tabletop, standup, or sitdown models. They come in a variety of materials, and vertical and horizontal flow combinations. Here are features of some of these benches.

Horizontal Laminar Flow – This is a general-purpose bench used for lab work, testing, inspection, manufacturing, and other operations. HEPA filter provides an ISO 5 working environment.

Vertical Flow – Has a self-contained filter unit that provides Class 100 HEPA filtered air flowing in a vertical laminar pattern. The filters are 99.99% efficient at 0.3 micron or larger.

Wet – Two-process bench comes with sump area with drain, PVC eye shield, rear-side exhaust connection and fume-control slot openings. Features can also include low profile casters, removable deck stations, and adjustable leveling legs.

Swing-Over – A gowning bench with a seating surface and raised platform for easier bootie/shoe cover application. Comes with a protective barrier between the controlled and uncontrolled sides of the gowning area.

Wafer Cleaning – This is a manually-operated acid cleaning tool. Features a partitioned slope, and a sump area separating processes and QDR waste and their drains. Fume-controlled area includes eye shield, updraft exhaust, and fume capture. Recirculation pump is also a waste transfer pump to drain.

Remember, any equipment you use for the purposes of a clean space are part of the validation process. If you have questions about cleanroom validation, construction, or certification, the experts at Gerbig Engineering Company will help. We have thirty years of experience in the field. Contact us at 888-628-0056 or email us at info@gerbig.com.

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