Compressed Air Lines in Cleanrooms Need Routine Testing

Compressed air is used in various applications in cleanrooms for a number of manufacturers. The applications can include injection molding, operation of conveyor belts, and the aseptic cleaning process.

Compressed air can be used because of the controlled environment a component is manufactured within, but what facility managers don’t always realize is that the compressed air system itself can harbor microorganisms. This can compromise sterility or other attributes of the products. Therefore, it’s important to implement a standard procedure for routine testing of the lines.

The air lines endure contraction, oxidation, sedimentation, and condensation when stagnant for a period of time, just like other dynamic systems. This makes it important to conduct testing more frequently during:

  • Seasonal changes
  • Replacement of parts (e.g. hardware, filters/dryers
  • An increase or reduction in production schedules
  • Inactivity of the system
  • Equipment modifications and changes

The simplest way to test the lines is to impact air onto a growth media. Equipment like a Slit Sampler forces Partial Flow of compressed air over a Petri plate. Whatever organisms are present become impinged onto the agar, which is incubated. The Slit Sampler method meets ISO 8573 standards.

Other microbial detection systems that may or may not meet the standards to which you’re held include these methods of capture:

  • Impaction
  • Centrifugal impaction
  • Multi-stage impaction

Whatever method works best for you will help ensure that your product is protected from environmental contaminants. Don’t neglect to test this potential threat to your product’s sterility.

Cleanroom certification and validation are also vital parts of maintaining compliance. It’s important to use a trusted company with enough experience to understand the process and the current standards. Gerbig Engineering Company has been testing cleanrooms for thirty years. We understand your needs, and we’re equipped to provide thorough, efficient service. Contact us at 888-628-0056 or info@gerbig.com.

Why More Cleanroom Managers are Outsourcing Cleaning

Who cleans your cleanroom? If you’re in the majority, your cleanroom workers are also taking on detailed cleaning responsibilities. Controlled Environments recently published the latest “Cleanroom Trends and Salary Survey,” and the cleaning trends have changed since last year. While the trend to use cleanroom workers as the primary cleaning staff rose slightly, from 42% to 46.3%, the other two categories saw significant change. People using an in-house cleaning staff dropped from 33% to 20.7%. Responders who say they outsource cleaning rose from 24% to 32.9%.

What’s causing fewer people to employ an in-house cleaning staff and more people to hire an outside cleaning company?

The most obvious reason a cleanroom facility wouldn’t hire an outside cleaning company is the expense. So if outsourcing is becoming more popular, the value of this service is probably becoming more evident. Let’s look at some of the costs a professional cleaning company helps cleanroom managers avoid.

  • Equipment and cleaning products. Any cleanroom facility needs cleaning tools regardless of who cleans it, but routine cleaning and less-frequent major cleaning jobs require more specific instruments that can be quite an investment. They also pose additional maintenance, disposal, and replacement costs.
  • Training and compliance. Cleanroom cleaning is so specific that there are protocols right down to the direction in which you can wipe a surface. Training for this job is extremely detailed, and it’s paramount that staff follows SOPs exactly or the room may not remain compliant. This, of course, would lead to even bigger problems.
  • Labor. The bigger cleaning jobs require extra staff, and arranging additional, qualified labor can be a drain on resources. Also, back-up cleaners are necessary to fill in when a primary staff member is ill or unavailable.
  • Quality of work. A cleanroom employee’s strengths and passions will lie in the actual work he or she performs in the cleanroom, not the cleaning tasks. Doubling up on duties can potentially hurt the quality of work performed during a shift and the cleaning itself.

Realistically, some cleaning jobs are going to be best handled in-house while others will make better sense to outsource. Anyone considering a change in how cleaning is handled should analyze the specific cleaning needs against the workflow to determine when and where a designated cleaning staff would most benefit the company.

When it’s time for the important cleanroom certification and/or validation, contact Gerbig Engineering Company. Cleanrooms have been our specialty for thirty years: 888-628-0056; info@gerbig.com.

Benefits of High Containment Glove Boxes for Pharmaceuticals

If you’re using or considering a standard Class III Bio Safety Cabinet, you may find it more beneficial to use a High Containment Glove box.

The pharmaceutical industry deals with a lot of different chemicals and compounds. Personnel protection is of great concern for Class III biological applications. That’s why the Class III Biological Safety Cabinets (BSCs) are designed with the highest containment capabilities – keeping people, products, and the environment safe.  Typical glove boxes are Class II cabinets, and not appropriate for this industry. However, High Containment Glove boxes (HCGs) are akin to Class III BSCs, but with added benefits.

Used in the pharm industry for years, HCGs are totally enclosed, HEPA filtered boxes with glove ports. They have been known to provide better environmental attributes than standard BSCs. Here are a few of the benefits by comparison:

  • Nothing in the glove box is re-contaminated. There is a once-through airflow requirement, so air doesn’t circulate.
  • The relative humidity is controlled. A nitrogen or argon purged environment provides less than 1% humidity at atmosphere or a slight negative pressure.
  • Bacterium is better controlled. The purged environment creates less then 2-3% oxygen, which critical to controlling some bacterium.
  • These glove boxes have a cross flow rather than a downward/upward flow like BSC cabinets. This creates less turbulence, making finite weighing activities possible.
  • The surfaces of these glove boxes have better cleaning attributes because of passivation of the main chamber.
  • Decontamination can be accomplished with UV lighting.

Overall, the robust design of the HCG offers better control than BSCs for any bio hazardous application, and they typically cost less. They are a safe and efficient alternative to consider.

Gerbig Engineering Company provides cleanroom validation and certification services as well as modular cleanroom construction. Our founder has been designing, constructing, and certifying cleanrooms since 1967. We offer quality service you can depend on. Let us know what you need for your cleanroom: 888-628-0056; info@gerbig.com

Options for Airflow Monitoring in Pharmaceutical Cleanrooms

How can pharmaceutical cleanrooms ensure compliance between certification visits if they don’t have centralized airflow monitoring?

Some existing pharmaceutical cleanrooms were designed without centralized monitoring systems. For these facility managers, certification is their primary means of ensuring compliance. It would be ideal, however, to know when intervention may be necessary during daily operations. The big question is: how do you accomplish this without adding considerable cost or disrupting the facility?

In the absence of airflow monitoring, what makes the most sense is to monitor the differential pressure maintained between the controlled environments and surrounding space. When changes occur in differential pressure, it often means that there are filter blockages or FFU failures. This is enough information to investigate the source of a problem.

The simplest way to accomplish this is with stand-alone censors. You can mount them inside the cleanroom so that staff can manually check the values. They would have to determine if the changes are significant and keep a through record of the data.

A more sophisticated process uses wireless censors that transmit data to a central computer where it is analyzed and recorded. These kits can come with various sorts of alarms and notifications to alert you when changes need your attention.

If you’re constructing a new facility, your options become more intricate. Network-capable FFU units supply centralized monitoring and airflow control, and they can be programmed to adjust and optimize air exchange based on the data it receives. Facility managers have a lot of options with this kind of technology; prices fluctuate with the capabilities, of course.

Real-time monitoring will supplement compliance between certifier visits. Those with existing facilities do have non-invasive, cost-efficient options that work well. If it’s time for cleanroom certification, contact Gerbig Engineering Company. Our experts have thirty years of experience. We also do validation and construction: 888-628-0056; info@gerbig.com

Environmental Concerns When Designing your Cleanroom: External

Environmental factors can create unexpected problems with your air intake system. Don’t be susceptible to these surprises. Know how to prepare.

When you complete construction on a cleanroom, the last thing you want to find is that you overlooked a major source of contamination. One of the most missed pieces in the design phase is the environment surrounding the facility. There are numerous ways the external environment can hinder your efforts to maintain proper indoor air quality. Missing one can cause a lot of agony for you later on.

In the last article on indoor environmental concerns, we focused largely on humidity. This is one of the most obvious detrimental influences in the environment, both outside and in. If the climate you’re in gets humid, you do need to factor that in when designing your cleanroom.

It doesn’t stop at humidity, however. Weather is the least controllable aspect of your environment, and you need to account for everything you could get hit with in your region. For example, if it snows where you live, your air intake systems need to be engineered to account for very fine snow that can fall during extreme cold. Cover all the weather possibilities when discussing your air intake system with your engineer.

Beyond weather are other influences that can overwhelm your system. Process exhaust of nearby operations can be of concern. Street level contaminates can be present, too, like those generated from loading docks or running vehicles. Survey the area for these kinds of toxins and choose your air intake system location accordingly. Furthermore, assess your environment regularly to catch any possible influx or unexpected factor that could overwhelm your system.

Once you have accounted for all environmental concerns, your cleanroom design will be better equipped to remain compliant throughout operations. When you need cleanroom validation or certification, call Gerbig Engineering Company. We offer full expert services and can answer any questions you have about the processes. Tell us how we can help you: 888-628-0056; info@gerbig.com.

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