Non-Sterile Cleanrooms and Microbial Monitoring Programs

certification_testing_mainThere are several reasons one would establish a microbial monitoring program for a non-sterile cleanroom. Among them are evaluating sanitization and disinfection efficacy, monitoring cleanroom production and lab environments, monitoring and qualifying personnel, and validating the cleaning process in and of the cleanroom.

One should always consult industry references for guidance, but we will outline three parts to establishing your program. (A few references: IEST-RP-CC023.3, Microorganisms in Cleanrooms (IEST will publish in 2014); ISO 14698 – 1 & 2, Biocontamination Control in Cleanrooms and Associated Controlled Environments; USP <1115> Bioburden Control of Non-sterile Drug Substances and Products)

Step 1. Analyze your Risk

The first thing you want to do is identify risks to the product and process for potential contamination. Jan Eudy of cemag.us suggests six questions to ask:

  • Is the product and/or process sensitive to changes or extremes in temperature and/or relative humidity?
  • What is the risk of microbial contamination to the product and/or process?
  • What are the customer’s specifications?
  • Are there any safety concerns?
  • Have there been any changes in the existing cleanroom facility?
  • What are the regulatory requirements?

 

Use the answers to these questions to establish your procedure, metrics, and corrective action. Important things to remember:

  • Routinely check HVAC system compliance, as it helps control microorganisms.
  • Ensure proper gowning and adherence to cleanroom personnel practices. People are responsible for most contamination.
  • Ensure that you have an effective cleaning program developed. Your sanitizers and disinfectants should be determined, validated, and then implemented into your cleaning program. The monitoring program tests the efficacy of these products.

 

Step 2. Sample

For sampling, you want to determine the number and location of sampling sites as well as the frequency of sampling. Typical sampling sites include: areas near open and/or filled containers (or filling line), room air by work areas, floors/walls/door handles/curtains, and personnel.

You do have to determine and proceduralize your method of sampling air and surfaces microbials. Your procedures need: purpose, scope, references, specifications (including action/alert levels), methods, map of sampling locations, and corrective action.

Your method for sampling air microorganisms will likely use one or more of the following:

  • Impactors
    • Slit
    • Sieve
    • Centrifugal
    • Cyclone
  • Liquid impingers
  • Filter collection
  • Sedimentation

 

For surfaces, you’ll use a contact plate for flat surfaces and swabs for irregular surfaces.

Step 3. Monitor

Finally, you will perform ongoing monitoring and analysis of date. The constant, consistent evaluation of data is critical to the success of your microbial monitoring program.

When corrective action is necessary, your failure analysis should include: a description of non-conformance, possible causes of the problem, identification of person responsible for creating/implementing corrective action, description of corrective action/schedule for implementation, and an evaluation of effectiveness of the corrective action.

Remember when performing corrective action, take a “do no harm” approach. With a proper microbial monitoring program established and carried out, you will maintain a useful status of your cleanroom’s past and present.

For questions about validation, certification, or other cleanroom topics, contact Gerbig Engineering Company. 888-628-0056; info@gerbig.com.

*For a thorough description of the above steps, see http://www.cemag.us/articles/2014/06/microbial-monitoring-programs-non-sterile-operations

 

Considerations for Going Green with your Cleanroom

South Coater Glass WallsBuilding or retrofitting an operation to be environmentally friendly is not a new idea, but it is an increasingly popular one. On top of numerous benefits, executives feel it is both the “right thing” and expected by clients. However, with cleanrooms, there are many people who decide not to go green. Here we will outline some things to consider for your own facility.

Leadership in Energy and Environmental Design (LEED)

Leadership in Energy and Environmental Design (LEED) is the most widely used green building certification program in the world. It is a voluntary program providing third-party certification of green buildings through the US Green Building Council (USGBC). It’s a certification process for materials, methods of construction, operation, and also maintenance.

There are, however, alternatives. Green Globes touts its program as “interactive, flexible, and affordable, and providing market recognition of a building’s environmental attributes through third-party verification.” ENERGY STAR is a U.S. government initiative. If you are building or remodeling outside of the U.S., you have other options to research as well.

Benefits of a Green Cleanroom

The benefits of going green – whether building from scratch or retrofitting – are many. Among the most significant are:

  • Improvements to the bottom line
  • Reduced operating costs
  • Reduced energy costs
  • Reduced water consumption

McGraw-Hill Construction (MHC)’s 2013 Dodge Construction Green Outlook reported that new green building projects saved a median of 8% over one year and 15% over five years. Building values increased by 7%. Green retrofits experienced higher savings in operating costs, decreasing 9% over one year and 13% over five years. Asset valuations increased more modestly, however, at about 5%.

Payback on green efforts is expected within eight years for new projects and seven years for renovations. However, a case study in the MHC report took only two years.

Downsides of a Green Cleanroom

There are a number of reasons that companies do not seek green certification. Among them are:

  • Cost of the certification process
  • Staff time required
  • Time required for the process
  • Overall (perceived) difficulty of the process

Ultimately, the decision will be different for each company. Looking at all the certification options, one may be more appealing than the others. For example, if energy efficiency is a priority, the ENERGY STAR certification may be the most relevant option to weigh.

Key Questions:

Richard Bilodeau, PE in his Controlled Environments article, “To LEED or not to LEED?” offered ten key questions to answer when making this decision:

    • • What’s the expected cost? The expected timeline?
    • • Do you have the staff to manage and see the certification process through?
    • • Do you anticipate disposing of the property or the business in the near future? As part of an acquisition or outright sale? Or do you anticipate retaining the asset? Is there a value to the certification in any of these scenarios?
    • • How important to your company is the “brand value” of a third-party certification?
    • • How much value would a third party certification hold for your clients or customers? For your investors? For your employees?
    • • Are you a publicly traded company with significant expectations for your Corporate Social Responsibility (CSR) program?
    • • Will the certification process assist in guiding the choices you must make during a building design and construction program?
    • • How does the “C-suite” weigh in? How does your Investor Relations department feel? Legal? Corporate Communications? Human Resources?
    • • If you pursue and obtain certification, what’s your plan to maximize its value to your business post-award?

With these points in mind, you will be able to make a more informed, competent decision about going green.

Gerbig Cleanrooms is your resource for cleanroom certification and validation. For questions regarding the cleanroom industry, contact us at 888-628-0056 or info@gerbig.com.

How to Support the Integrity of your Cleanroom through Conversation

certification_testing_mainCleanrooms depend on people in a number of ways. Staff is needed to carry out tasks, but they are also responsible for completing tasks correctly. In a cleanroom, there is a very clear, “correct” way to perform duties. Furthermore, people are most responsible for producing contaminates. Any failure in a cleanroom is most likely the result of a person who didn’t follow protocol.

Why does this happen? Good people and good workers are still prone to mistakes, but that isn’t entirely what is wrong. People who are not engaged, improperly trained, or not invested in the company’s mission are less likely to give it their “all” when at work. So how does a manager help staff be all they can be?

It turns out that simply talking to employees will help dissolve issues that cause apathy, carelessness, or unproductiveness. According to Controlled Environments’ “Mind Reading for Managers” by Kim Seeling Smith, there are 5 conversations to regularly have with employees.

  1. Feedback. This is a two-way street. Listen to the feedback from your employees. People who feel that they make a difference for their company are happier. Also, give feedback to employees, especially praise. People need to hear when they’re doing a good job as much as – if not more than – when they need to improve.
  2. Expectations. Be sure that you and employees share the same understanding of expectations and objectives. Also, provide a clear explanation of how success and/or performance is measured. You’d be surprised how differently people can perceive identical information.
  3. Employee development. If an employee thinks he or she does not have a future at your company, that person will feel like he or she is going nowhere with that job. Help develop your employees, identify career paths for them, and support their growth. They’ll work harder in their current roles and shine in future ones.
  4. Underlying motivators. Find out what else besides money drives your employees to go the extra mile.
  5. Strengths. Thanks to the strengths-finder test, many of us are familiar with the benefit of knowing our strengths. Rather than laser-focusing on what needs improvement, employees identify what areas they naturally excel at. This doesn’t mean a person shouldn’t improve on areas of struggle, especially when succeeding in that area is necessary for the job. It means that people will be a better fit for their jobs, experience less stress, and naturally flourish in roles that support their strengths. You don’t need to administer the strengths-finder test to accomplish this. Spend a little time each week identifying your employees’ strengths and helping them do their jobs according to what they are best at.

 

Employees who feel like they matter are happier. Employees who feel cared about care more about their jobs. Employees who feel supported by their managers will work harder. You need people to show up to work every day with focus and purpose. It’s as simple as a conversation, and you can start today.

If you have questions or needs pertaining to cleanroom verification, certification, or construction, contact Gerbig Cleanrooms. We are experts who care about you. 888-628-0056; info@gerbig.com.

Lighting Your Cleanroom

Installing lighting systems in a cleanroom can be a challenge because of the air filtration systems. Depending on the class of cleanroom, the ceiling may be covered with filters, leaving little room for light fixtures. Yet finding a lighting system that works effectively with the HVAC system is only one piece of the puzzle. You still need fixtures that maintain the integrity of the workspace, require little maintenance, and of course, provide appropriate light.

Cleanroom Lighting Fixture Styles

When choosing your lighting system, the first thing you’ll look at is the fixture style. There are three common ones, and choices depend largely on cleanroom class.

ISO 8 to ISO 5: Recessed troffers are most ideal in these environments. There is enough space in the ceiling and plenum in all cases. Your typical ISO 8 – 5 cleanrooms are pharmaceutical, semiconductor, chemical lab, and electronic assembly.

ISO 5 and ISO 4: These are moderately demanding classifications. For an open-area design, surface-mount teardrops are suitable light fixtures. They are mounted to a 2-in.-wide ceiling grid individually or in a continuous row. The aerodynamic shape of these fixtures minimizes disturbances in the laminar airflow.

ISO 3 and ISO 4: With the high air filtration requirement here, there is not enough room for recessed troffers. Surface mounts are installed below the ceiling plane and are therefore very efficient.

 

Additional Cleanroom Lighting Considerations

Once you’ve selected the appropriate fixture style, you need to focus on the exact fixture. To do so, you want to know what affects the quality of light. Most cleanroom facilities produce or handle small objects, so proper illumination is vital. There are three basic areas to become familiar with:

  • • Light Levels. Your illumination requirements will vary depending on the different process areas. In each, you want the fewest number of fixtures to obtain the desired amount of lighting. Your lighting manufacturer may be able to help you determine this by reviewing the layout of your facility. Remember that you also need to minimize glare. Fluorescent lighting is the most common. In the future, LED will be more available for a controlled environment.
  • • Housings. Certain materials best resist contamination and withstand rigorous cleaning procedures. These materials are usually aluminum, stainless steel, or carbon steel. Your fixtures should be welded or sealed shut. If your cleanroom needs to be hosed down periodically, you’ll need to wet-list your fixtures.
  • • Lenses. For easy cleaning and minimal dust/dirt accumulation, lenses should have a smooth outer surface. Acrylic lenses are the most durable, making them the most popular. There are many lenses and diffusers available for each classification level. Lenses can also be constructed with radio filters to not compromise any electronics in a semiconductor manufacturing facility.

 

Remember, your ISO class is your first concern when choosing your fixtures. Illumination, contamination, and maintenance considerations follow closely behind. With thorough research and understanding, you will find the lighting that is best suited for your cleanroom facility. For questions about cleanroom validation, certification, or manufacturing, contact Gerbig Cleanrooms at 888-628-0056 or info@gerbig.com.

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