To test a clean zone, there are several issues like smoke reflux, dead spots, and numerous smoke deviations to look for. It is important not to separate the media filter from the wall since the farther it is from the wall, the more reflux can be found.
Alternative technologies are available for the rapid detection of microorganisms.
To ensure efficient and reproducible cleaning, it is essential to match the cleaning agent to the plant technology. That is why so many different cleaning systems are available.
The ever-increasing demand for reliability, continuing miniaturization, and the growing number of faults in electronic components manufactured in no-clean processes all combine to put the focus back on cleaning in electronics manufacturing. The industry offers a variety of solutions to finding the optimal cleaning process.
Compendial microbiological methods have been in existence for many years, with only minor changes being incorporated. Recently, more rapid technologies have emerged and, in some cases, have received regulatory approval as alternatives to the traditional compendial tests.
When cleanrooms are used in manufacturing or scientific research, the doors and framing materials must have proper gaskets and seals to not allow contaminated air in or out of the area, and the door hardware must close and reseal after each personnel passage. However, additional door devices—such as card access systems, electric locks, station controls, and traffic lights—may be necessary to limit access to authorized persons.
As a Registered Cleanroom Certification Professional, I have seen an increase in the use of "clean zones" inside of cleanrooms in pharmacies. There are numerous types of unidirectional-flow devices that have been used in the past; however, when using a unidirectional-flow device in the compounding processes, the suppliers, customers, and certifiers need to keep in mind the meaning of the direct compounding area, first air, and critical site.
The HVAC system in any controlled environment is the kingpin of clean. When it comes to cleanroom HVAC, it's all about contaminants and environment control.
Manufacturers often ask how to achieve a clean space without using a cleanroom. There are many reasons to do this, including achieving a reasonable process flow and assuring economic competitiveness. A clean space involves basic design and structure. Achieving a clean space involves coordinating engineering planning and production activities with the facilities group, the customer, and with safety/environmental professionals.
Letter from the Editor - June 2013
You will want to consult with several cleanroom design/build construction companies to get their proposals for building an aseptic cleanroom to your specifications as well as the ISO 14644 and IEST industry standards.
Water is the most abundant cleaning chemical. With appropriate additives, water-based cleaning has proven successful.
Portable industrial vacuums are effective tools for cleanroom applications that require personnel to safely remove contaminants from controlled environments.
The problems with cumbersome insulation designs become very pronounced in the manufacturing cleanroom environment.