How Do your Cleanroom Habits Compare to Others?

Controlled Environments recently surveyed over 140 readers to uncover trends in the cleanroom business. Some of their findings might surprise you. Here is a snapshot of what they found:

What kind of facility?

Almost a quarter of respondents work in pharmaceuticals, and other popular industries included medical devices, aerospace, manufacturing, biotechnology, validation, and research.

Retrofitted facilities: 53%

New/custom-built facilities: 37%

Turnkey facility: 10%

Costs

When looking at the big picture, any facility manager is going to base decisions on cost at some point. When is cost most likely to be the biggest concern, and when is it not?

Purchasing items for the cleanroom: 46% say longevity and quality is most important, whereas 35% prioritize cost, and 8% want the newest models available.

Supplier/distributor for equipment supplies: 35% consider cost most important; 26% are most concerned with vendor reputation/reviews, and 11% choose the same company every year.

Along the line of costs, what day-to-day items and services are most participants spending money on?

74% – cleanroom consumables (wipers, swabs, etc.)

69% – cleanroom attire (the majority uses single-use, disposable attire.)

66% – monitoring/instrumentation systems

46% – cleanroom services

Cleaning

Speaking of cleaning services, who is in charge of this important task? There are many articles that recommend using staff separate from those working in the cleanroom all day. Does this reflect real life?

It doesn’t for 42% of the responders. They all have their staff stay and complete cleaning duties. 33% use an in-house staff that is solely dedicated to cleaning. 24% use an outside cleaning company.

Inspections

How often does an outside firm inspect these facilities? For 35%, it happens more than once a year. 22% host an inspection every 2-5 years; 9% host every 5-10.

It’s always interesting to see how one’s own facility compares to the trends of the industry. For the full article, click here. For cleanroom validation, certification, and construction, contact Gerbig Engineering Company. We will help keep you compliant and profitable. Call 888-628-0056 or email info@gerbig.com.

How Cleanroom Contamination Risks Differ by Industry

What is the difference in cleanroom contamination concerns amongst the industries, and what is the best way to ensure compliance?

Contamination to the product in any cleanroom is very costly. Contaminated products can’t be sold, so the investment in raw materials and labor is completely lost, and starting over means duplicate costs.

The two sources of contamination are particulate and microbial. Most commonly, humans are the vehicle for contaminates. In any case, sources and entry paths don’t vary significantly by industry.  What is different amongst the industries is tolerable versus intolerable levels of contamination.

A high-tech manufacturer makes microscopic products that can’t accept any particulate contamination at all. The tiniest speck of dust would look enormous on a microchip. However, the focus for these products is the sterility of the chip. Mold, fungus, and other forms of contamination are of no concern. A high-tech device only has to pass the company’s own internal checks. If a laptop of television works, it ships.

On the other hand, the pharmaceutical industry has to adhere to strict FDA and Good Manufacturing Practice (GMP) regulations. Pharmaceutical manufacturers don’t just need products to be microbial-free; they also have to verify their paper trail for everything. They can’t check their product by plugging it in and turning it on. That’s why it’s so important for these organizations to have, use, and document cleanroom procedures.

It is a wise idea to hire professional and experienced outside help to clean a cleanroom at the end of the day. The last thing that internal staff wants to do at the end of a long shift is painstakingly clean all of the equipment in their lab. With the right experts and equipment, your environment should exceed the highest regulations for contamination control, maintenance, cleanroom control, and safety.

If you need your cleanroom certified or validated, trust the experts at Gerbig Engineering Company. We have been working with cleanrooms since 1985. Call 888-628-0056 or email info@gerbig.com.

8 Steps to Successful Cleaning and Cleanroom Disinfection

Cleaning and disinfection are two separate but equal processes in cleanroom compliance. Know these 8 steps.

Our last two posts addressed some common concerns and issues in choosing cleanroom disinfectants. Achieving the appropriate microbiological cleanliness levels for a class of cleanroom is paramount to industries like medical device assembly and pharmaceutical manufacturing.  Disinfectants and applicators are only two pieces of the puzzle. Here are 8 steps to keep in mind when ensuring your cleanroom is kept clean.

 

  1. Know the difference between cleaning and disinfection. Cleaning surfaces is basically removing soil, like dirt, dust, and grease. Detergents are typically used in this process, and it must be completed before disinfection. Chemical germicides used to disinfect eliminate vegetative microorganisms. Both steps are important, and they must be done in the right order.
  2. Choose the right agents. Between class, purpose, and equipment, cleanrooms differ in the kind of cleaning and disinfectant agents that are most appropriate for compliance and validation. We wrote this article about considerations for disinfectants. For your cleaning detergent, make sure:
    • It is neutral and non-ionic
    • It does not foam
    • It’s compatible with the disinfectant
  3. Understand the difference among disinfectants. Specifically, you need to know how the agent acts against parts of the microbial cell. You need to know how to choose between non-sporicidal and sporicidal disinfectants, or non-oxidizing and oxidizing chemicals.
  4. Validate your disinfectants. This is especially important for pharmaceutical facilities. You need to challenge the disinfectant solution as well as different surface materials and ranges of microorganisms. The manufacturer can perform some testing, but some should be performed in-house.
  5. Know the factors affecting disinfection efficacy. There are a number of things that will challenge efficacy:
    • Concentration
    • Time
    • Number and type of microorganisms
    • Temperature and pH
  6. Cleaning materials. We discussed applicators in this post.
  7. Cleaning techniques. Whether it is the direction you sweep/mop, method of application, allowing product to dry, or any other protocol, be certain that you clean/apply exactly as is specified.
  8. Monitoring efficiency. As with any protocol for a cleanroom, test and monitor your method with microbiological sampling of surfaces.

If you need validation or certification, or if you have questions about these processes, consult Gerbig Engineering Company. Our 30 years of experience makes us experts at cleanroom construction, certification, and validation. Contact us at 888-628-0056 or info@gerbig.com.

The Most Overlooked Step in Cleanroom Disinfectant Programs

Disinfectant programs for cleanrooms rely on more than the solvents themselves. Don’t overlook this important piece of the puzzle.

In our last article, we covered a six-step checklist for choosing disinfectants for your cleanrooms. When it comes to controlled environments, however, it’s necessary to create a disinfectant program.  While the solvents and solutions themselves are key, they will not do their jobs properly if you overlook another important element: the applicator.

One of the most overlooked steps in developing a disinfectant program is careful consideration of the proper tools used to apply the solution(s). This is a grave mistake. Using the wrong applicator can compromise the integrity of the active ingredients.

Even the smallest variables can cause improper disinfection surfaces. They can range from the fibers of the applicator to protocol for applying solutions. Of course, how facility workers interpret and implement protocols affect a disinfectant’s effectiveness, too.

Least Effective Materials

Studies support the conclusion that natural fibers generally make poor applicators for disinfectants. This is truer with certain solutions, like ready-to-use hypochlorite (bleach) and quaternary ammonium (quats). The active ingredients in these solutions will bind to natural fiber wipes and mops. This causes the solution to lose strength, rendering it ineffective in achieving the kill claims of the manufacturer.

Another down side to using natural fibers is that they are difficult to dry. If dried incorrectly, natural fibers can grow bacteria. This obviously compromises the efficacy of disinfection. If you must use natural fibers, choose single-use mops and wipes.

A Better Choice

On the other hand, synthetic products do not pose these problems. Materials like polyester and polypropylene don’t exhibit the binding phenomenon, so solvent strength is unaffected. Synthetic materials also do not pose the same opportunity for bacterial growth that natural fibers do.

Choosing the proper solution and the right applicator will help ensure you meet certification and validation. Questions about cleanroom validation, certification, or construction? Contact the experts at Gerbig Engineering Company. We’ve provided cleanroom services for 30 years. Call 888-960-0056 or email info@gerbig.com today.

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