4 Types of Modular Cleanrooms Part 2

Further discussion on the options one has for modular cleanrooms as opposed to other controlled environments.

Modular cleanrooms are a popular alternative to other kinds of controlled environments because they are convenient and reliable. In part one, we discussed two of the four types of systems. Here we will cover the remaining two.

Structural post and panel

Most modular manufacturers have a core product that acts as an “all-purpose” system. These products can be utilized for numerous applications, from particular ISO classes to GMP rooms. The versatility that these systems provide make them appropriate to outfit existing facilities or build freestanding structures to envelop separate, compartmentalized processes.

A post-panel design provides even more flexibility to these systems. A variety of wall panels and cores can be integrated to meet various needs and applications. These include: polystyrene, aluminum honeycomb, fiberglass reinforced plastic, and stainless steel.

Quality control enclosures, inspection rooms, medical device packaging areas, machinery enclosures, and USP 797 compounding labs are all examples of applications that benefit from these all-purpose cleanroom systems.

Framing and partitioning systems

These are typically the ideal solutions for applications demanding a lot of precision, like microelectronics and nanotechnology. They require systems that integrate well with the equipment used to run the operations. Framing systems feature both vertical and horizontal members that connect easily, therefore simplifying bulkheading as well as creating airtight seals around equipment. The walls can easily be removed without removing adjacent panels, ceiling grids, or framing studs.

Something to be aware of in the microelectronics industry is that cleanrooms usually require anti-static wall panels hat are non-shedding and non-outgassing. Honeycomb aluminum panels have proven to perform well, but they are expensive. More cost-effective designs are often available if you compare your needs with what manufacturers have to offer. With a little research, you could reduce the cost of your cleanroom without sacrificing functionality or performance.

Depending on your application and needs, either a softwall, aseptic, structural post-panel, or framing system will meet your modular needs. Gerbig Engineering company’s AireCell line is especially cost-effective. The aluminum and PVC extrusions are quickly installed and offer design flexibility. Contact us to discuss the AireCell systems: 888-628-0056; info@gerbig.com.

4 Types of Modular Cleanrooms Part 1

Modular cleanrooms are a popular alternative to controlled environments. The appropriate one for you depends on your specific needs.

Modular cleanrooms offer a variety of benefits to those who need a controlled environment. They’re quick and clean to install, consistent in quality, and offer some green benefits as well. In an evolving market, new systems become available, giving consumers more to choose from.

Modular cleanrooms are categorized in four styles: softwall, aseptic, structural post and panel, and specialty systems (they include framing or partitioning.) Let’s take a look at the first two kinds of modular systems.

Softwall Cleanrooms:

If you require light environmental control, these systems are a very economical option. They can be erected quickly and consist of metal framing, flexible vinyl curtain walls, and numerous fan filter modules to control particulate and air flow. These are probably the most mobile systems available.

Other advantages to softwall cleanrooms make them easy to incorporate into a variety of applications and other cleanroom systems. Mounting methods, closure, and fastening systems allow them to be used as partitions within larger environments or to create cleaner interior zones. They even come in several finishes, like transparent, tinted, and opaque to widen their applications.

Overall, these are very common to use for basic environmental control to inspection rooms, manufacturing areas, GMP rooms, and machinery enclosures.

Aseptic systems:

While softwalls are designed for lighter environments, aseptic systems are designed to meet the requirements of life science, biomedical, pharmaceutical, and medical device markets.

These systems have a completely seamless interior as well as durable, non-shedding wall panels designed to withstand repeated cleaning and sanitizing. The design eliminates the potential buildup of contaminants within the environment. All of the advantages of these systems serve to meet the unique requirements of the specific industries mentioned above.

One of the most reliable and advanced modular cleanroom systems is the AireCell line created by Gerbig Engineering Company. This specialized line of aluminum and PVC extrusions are quickly installed and cost-effective. Contact Gerbig to discuss whether the AireCell system is right for your application: 888-628-0056; info@gerbig.com.

ESD Flooring Options for your Cleanroom

If you are controlling ESD in your cleanroom, you need to choose the right protection for your floor. Here is a comparison of basic options.

Electrostatic discharge (ESD) can cause damage to electrically sensitive equipment and analytic processes as well as cause a fire or explosion near flammable materials. Using ESD flooring helps ground personnel in an effective and economical manner.

Your ESD flooring selection process should begin with an evaluation of both your intended use and possible future uses. Your intended use includes:

  • Evaluating devices or processes most sensitive to ESD events
  • Chemical resistance
  • Aesthetic requirements

Every type of material used for ESD flooring will have advantages and disadvantages in each specific environment and application, so consider the following options with that in mind.

  1. Resilient ESD tile and sheet goods. If there is neither danger of liquid spillage nor presence of heavy point loads, these products offer good general service. They’re fairly economical and come in a variety of colors and finishes.
  2. ESD carpet. Carpet offers ergonomic value and sound reduction, but non-ESD carpet is a major source of electrostatic discharge. With conductive fiber and backing, this option provides effective grounding of potentially damaging charges. ESD carpet finishes are typically reserved for administrative areas.
  3. Two-component ESD epoxy floor paints. These are water-based products applied in thin films. This makes it inappropriate for applications under heavy physical use, but it’s an economical option for flexible spaces or large areas with light to moderate levels of use.
  4. Polymer ESD coatings. These provide a seamless surface resistant to liquid spills. Variations are available for chemical resistance and/or slip resistance. As the options get more advanced, they provide better protection under heavy loads .

There are also temporary solutions best used as a stop-gap measure, like ESD waxes and other topical treatments. Again, your evaluation of current and future uses will determine which option is right for you.

When you need cleanroom validation, certification, or expansion, contact Gerbig Engineering Company. We provide expert solutions and thirty years of experience. Call 888-628-0056 or email info@gerbig.com today.

Properly Selecting and Using a Cleanroom Vacuum

What you need to know about one of the most important pieces of equipment in your cleanroom.

We recently posted a comparison to help you choose between a central and portable vacuum system for your cleanroom. Once you decide which system is right for you, there are a few more things to know about picking out your vacuum.

Crucial Elements of the Equipment

The absolute first thing you must ensure is that your vacuum cleaner is HEPA-filtered. This is the only way to know that 99.97% of particles down to and including 0.3 microns are collected and retained.

Another critical piece of the filtration system is when the HEPA filter goes in. It should be installed after the motor to filter the exhaust stream. The commutator and carbon brushes in the motor generate dust; if the exhaust stream isn’t filtered, that dust will be released into the room.

You will also need a multi-stage, graduated filtration system. This uses a series of finer filters to trap and retain particles moving through the system. It will also protect the HEPA filters from blockage and excessive wear and tear.

The filters should be oversized to slow airflow and optimize the air-to-cloth ratio. The vacuum will be able to collect large volumes of debris over long periods of time with minimal maintenance this way.

The unit itself should be constructed of non-particle-generating materials. Stainless steel vacuums, for example, should have smooth hoses and attachments so personnel may quickly wipe down and decontaminate equipment.

Another important component of your selection process is the manufacturer. Select one that offers a complete line of vacuums that are specifically designed for cleanroom applications. These manufacturers will offer other essentials: FDA-approved hoses, cleanroom-packaged vacuums, explosion-proof vacuums, and wet/dry vacuums.

Keeping it Clean

Once you have the right unit(s) for your controlled environment, there are things you can do to maintain optimal cleanliness:

  • Educate your staff on proper use of the equipment as well as protocol for hygiene
  • Maintain your equipment with regular cleaning and checkups on all the parts
  • Develop a schedule and enforce it to ensure comprehensive vacuuming of the entire facility after each shift

Vacuums are a key piece of keeping a cleanroom clean and compliant. When it’s time for validation, certification, or expansion of your cleanroom, choose Gerbig Engineering Company. We have a solid reputation and understanding of the industry. Call us at 888-628-0056 or email info@gerbig.com.

Important Considerations for Cleanroom Vacuums

There are advantages to both portable and central vacuum systems for a cleanroom. Weigh your options with these comparisons.

When looking at everything needed to clean a cleanroom, the initial removal of dust and particles comes before sanitation. In critical cleaning situations, vacuuming tends to be a more efficient method than swabs and cloths. Measurements taken in a cleanroom setting show that dusting systems using disposable cloths polluted the space twice as much as a HEPA filtered vacuum cleaner.  Vacuums both retain particles inside the machine and eliminate fiber particles left behind by various wipers.

The first question you need to consider when choosing a cleanroom vacuum is: central system, portable, or both? While experts will argue for each option, the best choice for you depends on your application. Here are the pros and cons of the two systems:

Portable

  • PRO: Personnel can effectively and easily clean their areas at the end of each shift. These vacuums are best for areas where human contamination is prevalent.
  • PRO: These vacuums can be designed for both wet and dry applications, whereas the central systems can only pick up dry materials.
  • PRO: These systems can reach places the central ones can’t, like overhead or remote areas.
  • CON: These units do occupy precious cleanroom space. Compact models are a popular choice for this reason.

Central

  • PRO: The greatest benefit of these systems is that personnel are able to dispose of collected dirt outside of the cleanroom. This then poses no threat to the manufacturing process.
  • PRO: They free up floor space as they’re located outside of the cleanroom.
  • CON: If you expand your operation, the central system may not have the capabilities to support your new area.
  • CON: If a contaminant enters it, the entire system may be contaminated. This requires a costly sanitation process to fix it.

Many cleanrooms do need a vacuum to have both wet and dry capabilities, so if you’re leaning towards a central system, you’re probably truly looking at having both systems. Once you know which system you want, you can focus on what to look for in a vacuum. We will cover that in our next article.

If you need cleanroom validation, certification, or manufacturing, choose a company you trust. Our experts bring 30 years of experience to our superior service. Call us at 888-628-0056 or email info@gerbig.com.

How to Swab Cleanroom Surfaces in a Reproducible Manner

Validation relies on meticulous and accurate testing. When swabbing for residue samples, follow this advice for reproducible results.

If you consider cleaning validation a three-step process, it will involve 1) cleaning/rinsing of necessary surfaces, 2) sampling any residues left behind after step 1, and 3) analyzing your samples. The greatest challenge in this 3-step process is ensuring that step two is carried out in a highly reproducible manner. If it isn’t, the analysis won’t truly represent the condition of the sampled surface.

To accomplish reproducibility, you want to focus on four things:

  • Thorough completion of step one
  • Use the proper swab
  • Wet the swab correctly
  • Swipe the area consistently

The first step above is rather obvious. If you can actually see particles on any surface, you need to clean it. The residues you’re testing are invisible to the naked eye. Moving on to the second area of focus, the best swab for sampling will be made from laundered polyester knit fabric. This material releases the fewest particles, has the highest recovery, and provides the lowest background when TOC measurements are employed.

With the right swab in hand, in order to sample, the swab needs to be moistened. If you merely saturate the swab head with high-quality water, excess liquid will spread residue over the surface rather than collect on the material. The swab should be damp but not saturated. After immersing the head into a container of high-quality water, simply press both sides of it against the inside of the container to release trapped air. Draw both swab head sides across the rim of the container to expel excess liquid.

Once properly moistened, you want to use a consistent swabbing pattern. The area you’re sampling will usually be 5cm by 5 cm. Then use the following pattern:

  • Swipe the first side of the swab horizontally ten times over the sampling area.
  • Flip the swab and swipe the other side ten times vertically over the area.
  • Deposit the swab into a collection vial.
  • Use the first side of a second swab to swipe the same area diagonally upwards ten times.
  • Flip the swab over and swipe diagonally downwards ten times.
  • Deposit the second swab into the same collection vial.

The figure below shows the swiping pattern. It is taken from the cemag.us.com article “How To Succeed In The Search For Nothing: Effective Swabbing Techniques For Cleaning Validation” by Wendy Hollands, Howard Siegerman, Ph.D., Michael Strauss.

swabdiagram

Proper swabbing techniques will ensure that you get accurate results. For other questions about validation or cleanroom certification, contact Gerbig Engineering Company. We have 30 years of experience delivering expert cleanroom services. Call 888-628-0056 or email info@gerbig.com today.

3 Tips on Testing for Fungal Control in Cleanrooms

There is a lot to consider when taking action to control fungus in a controlled environment. Make sure you know these three tips.

Recently, we posted about controlling fungus in cleanrooms.  This is a tricky subject because it depends on the form of fungus, the surface type, and environment specific to your controlled environment. We ended the series with suggestions on the kinds of test you should perform. Here is some additional information to help with that process.

Suspension tests:

It is worth noting that there are many published methods to determine fungal activity in suspension or carrier tests. You can find general test procedures to use for fungicidal activity testing in the BS EN methods (1650 and 13697) established by the European Committee for Standardization and the AOAC. However, these methods are specifically used by disinfectant manufacturers to register a product for sale. Therefore certain methods won’t be applicable or necessary to cleanroom disinfectants. Know that you can make reasonable modifications so long as they are scientifically sound.

Which fungus to test:

Wondering which fungus to use as a test microbe, like yeast or mold? Generally, you want to use fungal spore suspensions of both reference cultures and environmental isolates. Consider this example:

The AOAC fungicidal test uses Trichophyton mentagrophytes as a reference organism. This doesn’t present as great a challenge to the disinfectants as does A. niger, so it is rather misleading. It is also not as common in pharmaceutical, biotech, and medical device cleanrooms. Consequently, the procedure should include A. niger and C. albicans as reference cultures.

Your disinfectant effectiveness testing should also include the specific environmental isolates most frequently found in the facility.

A couple extra notes about preparing suspension tests:

Prepare yeast suspensions from yeast propagated on media that results in rapid growth and smooth colonies. Remember that mature mold cultures are more resistant to fungicides than are yeast cultures. Prepare molds for validation testing as conidia suspensions with hyphal fragments removed. The conidia presents the greatest disinfection challenges.

Ensure that your tests are carried out thoroughly and carefully. Document everything and make sure you are current on validation and certification. If you need your cleanroom validated or certified, contact Gerbig Engineering Company at 888-628-0056 or info@gerbig.com. Our 30 years of experience make us experts who care about your business.

How to Control Fungus in Cleanrooms Part 2

Selecting a cleaning agent that is effective against fungal contamination in cleanrooms is a full process. This series identifies your steps.

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 type 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 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 Engineering Company at 888-628-0056 or info@gerbig.com.

How to Control Fungus in Cleanrooms Part 1

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 making 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

The next step in the process is to test the products. We will explain testing and methods in part 2. If you need cleanroom certification, validation, or manufacturing, or if you have questions about these processes, contact Gerbig Engineering Company. Our trusted experts have 30 years of experience. Call 888-628-0056 or email 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