The Ultimate Guide to ISO 23464:2020 Nitrile Cleanroom Gloves

In contamination-sensitive industries like pharmaceuticals, semiconductors, biotechnology, and aerospace, choosing the right cleanroom gloves is essential. Nitrile cleanroom gloves have become the preferred choice due to their superior chemical resistance, durability, and low particle contamination levels.

To ensure these gloves meet strict industry standards, the ISO 23464:2020 standard defines the classification requirements for compliant nitrile cleanroom gloves used in ISO Class 4, ISO Class 5, and ISO Class 6 cleanrooms.

If your business relies on critical environments, understanding ISO 23464:2020 is key to selecting the right nitrile gloves for your cleanroom operations.

What is ISO 23464:2020?

ISO 23464:2020 is the international standard for nitrile cleanroom gloves, outlining strict limits on:

  • Particle contamination
  • Ionic contamination
  • Non-volatile residues (TNVR)
  • Restricted substances

By following these guidelines, manufacturers ensure their nitrile gloves are compliant and suitable for use in highly controlled environments.

ISO 23464:2020 – Key Requirements for Nitrile Cleanroom Gloves

  1. Particle Contamination Limits

Measures the number of particles, larger than 0.5 µm, released by gloves per cm². The maximum allowable particle count per cm² is:

  • ISO Class 4: <600 counts/cm²
  • ISO Class 5: <1,200 counts/cm²
  • ISO Class 6: <3,000 counts/cm²
  • Particle are categorised by size: 0.5 µm – 1.0 µm, 1.0 µm – 2.0 µm, 2.0 µm – 5.0 µm, 5.0 µm – 10.0 µm, 10.0 µm – 20.0 µm, >20.0 µm
  1. Ionic Contamination Control

Ionic contamination can interfere with delicate processes, especially in the semiconductor and biotech industries. ISO 23464:2020 nitrile gloves have limits on the levels of the following ions: Fluoride, Chloride, Bromide, Nitrate, Phosphate, Sulphate, Sodium, Magnesium and Potassium.

  1. Total Non-Volatile Residue (TNVR) Restrictions

ISO 23464:2020 limits the presence of non-volatile residues:

  • ISO Class 4: <2.50 µg/cm²
  • ISO Class 5: <10.0 µg/cm²
  • ISO Class 6: <25.0 µg/cm²
  1. Prohibited Substances for Cleanroom Safety

Nitrile cleanroom gloves must be free from:
🚫 Silicone – Can interfere with adhesives and coatings
🚫 Amide – Can cause chemical contamination in sensitive applications
🚫 Dioctyl Phthalate (DOP) – A common contaminant in certain manufacturing processes

Testing & Compliance for ISO 23464:2020 Nitrile Gloves

To guarantee compliance, nitrile cleanroom gloves undergo rigorous testing:
🔬 Particle count analysis using liquid extraction methods
🔬 Ionic contamination testing via ion chromatography
🔬 TNVR analysis using gravimetric techniques
🔬 Restricted substance detection through FTIR (Fourier Transform Infrared Spectroscopy) analysis.

These strict quality control measures ensure that nitrile gloves meet ISO 23464:2020 standards before reaching the end user.

Proper Processing & Packaging for Nitrile Cleanroom Gloves

Manufacturing nitrile cleanroom gloves requires controlled environments and strict handling procedures to prevent contamination:
✔ Processing in controlled cleanroom environments to maintain ISO standards
✔ Laundering with ultra-pure RO-DI water (resistivity of 13-18 MΩ) to remove contaminants
✔ Low-particulate packaging materials to prevent contamination during storage and transport

Proper packaging ensures ISO 23464:2020 compliant nitrile gloves remain clean and ready for use in sensitive applications.

Why Choose ISO 23464:2020 Compliant Nitrile Gloves?

For businesses in pharmaceuticals, electronics, aerospace, and biotechnology, using compliant nitrile gloves is critical to:
✔ Minimise contamination risks in cleanroom environments
✔ Meet regulatory and compliance requirements
✔ Ensure product integrity and quality assurance

Nitrile gloves can offer better chemical resistance, enhanced durability, and lower contamination levels than latex, making them the preferred choice for cleanroom applications.

Final Thoughts: Choosing the Right ISO 23464:2020 Nitrile Gloves

Understanding the ISO 23464:2020 standard helps businesses select the best ISO-compliant nitrile gloves for their cleanroom operations. Whether your industry requires ultra-low particle counts, strict ionic contamination control, or residue-free gloves, choosing the right nitrile cleanroom gloves ensures compliance, reliability, and safety.

Need high-quality ISO 23464:2020 compliant nitrile gloves? Contact us to make the right choice today and protect your cleanroom processes from contamination risks.