The ABCs of Cleanroom Standards and Cleaning Protocols
Cleanrooms are the backbone of industries where the smallest contaminants can wreak havoc. These include the pharmaceutical, technological, and scientific research fields.
However, maintaining the strict conditions within these cleanrooms isn’t a walk in the park. It requires forethought and effective cleanroom supplies and consumables. Plus, there’s a need for robust standards and thorough cleaning procedures.
This comprehensive guide will delve deep into cleanroom standards and effective cleaning routines.
Cleanroom Overview: The Basics
Cleanrooms are controlled environments where pollutants like dust, airborne microbes, aerosol particles, and chemical vapors are kept at minimal levels. These standards are maintained by implementing complex systems that control airflow, pressure, and temperature. The level of cleanliness in a cleanroom is typically denoted by the number of particles per cubic meter at a specified particle size. For instance, the cleanest cleanrooms may have just 1000 particles of specific sizes per cubic meter.
Understanding Cleanroom Standards: ISO 14644 vs. U.S. Federal Standard 209E
To ensure consistency across the industry, cleanroom standards have been developed. The two most commonly referenced are ISO 14644 and U.S. Federal Standard 209E, which was replaced by ISO 14644 in 2001. ISO 14644 outlines specific limits for particles of varying sizes, starting at 0.1 microns, whereas Federal Standard 209E uses a standard particle diameter of 0.5 microns. The ISO standard offers a more detailed classification system, providing a clearer picture of cleanliness.
Importance of Particle Counts
The impact of particular particles on a production process is determined by their volume and size. Smaller components and more sensitive devices require cleaner environments and, thus, stricter particle thresholds. Consequently, methods for detecting and differentiating aerosol (airborne) particles have improved significantly.
Resources for Cleanroom Information
Several resources are available for individuals or companies seeking comprehensive information on cleanrooms and controlled environments. These resources provide cleanroom news, discussion forums, cleaning recommendations, and cleanroom terminology.
Disclaimer: Use Information Responsibly
While these resources are valuable, it’s crucial to note that the information they provide is contributed by various websites. Although every effort is made to keep the information up-to-date and correct, no guarantee is given about the information’s completeness, accuracy, reliability, or suitability.
Environmental Monitoring: Verifying Cleanliness
Your environmental monitoring (EM) program is critical to your cleaning routine. It determines whether your cleaning processes are effective. EM focuses on viable (living microorganisms) and non-viable (non-living) particles. Monitoring for both types of particles is crucial in determining the cleanliness of your critical environment. Here are some ways to monitor cleanliness:
- Active and passive air sampling
- Surface sampling with sterile swabs or contact plates
- Monitoring staff with contact plates
Monitoring Staff: The Human Factor
People are the primary source of contamination in a cleanroom. Therefore, your Standard Operating Procedure (SOP) should include strict cleanroom apparel procedures to prevent the introduction of viable and non-viable particles. Contact plates placed near your staff can help evaluate the effectiveness of your PPE and donning procedures.
Testing Cleanroom Surfaces
Monitoring surfaces like floors, walls, furniture, and equipment is essential, as these areas must be regularly cleaned and monitored for viable particle counts. Environmental surface testing can detect biological contamination and cross-contamination from previous production.
Sampling Air: The Invisible Threat
Air sampling is a crucial part of environmental monitoring. Your HVAC control systems should continuously monitor pressure, temperature, and humidity. In addition, routine monitoring for both viable and non-viable particle counts is necessary.
Maintaining cleanroom standards and implementing effective cleaning protocols is complex but necessary.
By following these guidelines, you can keep your cleanroom in tip-top condition. Remember: a clean cleanroom equals a successful operation!