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:
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 … Read More »
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 … Read More »
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 … Read More »
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 … Read More »
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 … Read More »