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Failing to Monitor Macroparticles?
Failing to Monitor Macroparticles?
Cleanrooms are classified by cleanliness levels, determined by the number and size of particulates in a cubic meter of air, as per ISO 14644-1 standards. These standards measure particle sizes of ≥0.1 µm, ≥0.2 µm, ≥0.3 µm, ≥0.5 µm, ≥1 µm, and ≥5 µm, primarily focusing on smaller microparticles.
It's also crucial to monitor macroparticles larger than 5 µm, as they can behave differently and impact cleanroom operations if not included in environmental monitoring.
This piece from Valutek's Cleanroom Catastrophes Case Study Series highlights the real-world consequences of failing to monitor macroparticles and common practice mistakes.
Standard Operating Procedures for Controlled Environments
The FDA Code of Federal Regulations (CFR) mandates written SOPs and document controls for all life science operations. Written SOPs demonstrate compliance with quality, cleanroom, industry standards, health, safety, environmental, and manufacturing regulations.
This technical series covers following chapters:
- Introduction to Writing Internal SOPs for Controlled Environments,
- Optimizing Cleanroom Operations: SOPs for Gowning Protocols,
- SOPs for Cleanroom Operator Requirements and Training,
- SOPs for Facility Maintenance,
- Cleaning, and Sanitization, SOPs for Critical Cleaning
Titanium Dioxide Free Cleanroom Glove
Engineered For Semiconductor & Advanced Microelectronics Applications
Constructed from synthetic nitrile polymer containing no Titanium Dioxide (TiO2) pigment.
In order to develop an additive-free nitrile material, Valutek has removed all color pigment — the source of a known contaminant, Titanium Dioxide — from this specific formulation.
The result is a cleaner, translucent glove with enhanced performance and operator comfort.
Recommended for use in a cleanroom Class 1-10 (ISO 3-4) critical environment.
Product Categories
Cleanliness Classification
Selecting the right products to use in your critical environment can be challenging.
Valutek has simplified the process and developed three product families: NanoTek, MicroTek, and MacroTek.
These product families are designed to guarantee the consistent and stable operation of your cleanroom processes.