Recommended PPE for Sterile & Non-Sterile Compounding According to USP-800

ISO 4 (Class 10) Cleanroom Wipes

ISO 4 Class 10 cleanroom wipes are used for a variety of wiping and cleaning applications in the most critical cleanrooms around

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ISO 4 Cleanroom Wipes

ISO 4 (formally class 10) controlled environments are among the cleanest of them all. This exceptionally critical environment requires a wiping substrate that is lint-free and low in pollutants. Wipes need to be manufactured and packaged in a cleanroom.

They should also be double-bagged to provide additional protection from outside contaminants. According the ISO 14644 Cleanroom Standards, an ISO level 4 environment can only have a maximum concentration limit (particles/m3 of air) of 10,000 equal to and larger than 0.1 micron.

ISO 4 Equivalents

Common Attributes of ISO 4 (Class 10) Wipes:

  • Lint-free material
  • Heat-sealed edges
  • Lowest in non-volatile residue and ionic levels
  • Close-knit construction
  • Cleanroom laundered, individually inspected, and double packaged in cleanroom bags
  • Fibers are continuous with no loose ends
  • Common substrates: Polyester, Poly-Cellulose, Polypropylene

ISO 3-4 Class 1-10 cleanroom wipes come in various types, each tailored to specific needs within the cleanroom environment. These wipes are engineered to handle the most critical cleaning tasks, ensuring minimal particulate and microbial contamination. The primary types include:

Dry Wipes: These wipes are ideal for dry cleaning applications and are typically made from nonwoven materials or laundered polyester. They are excellent for picking up dry particulates without introducing additional contaminants.

Pre-Saturated Wipes: Pre-saturated with cleaning solutions, these wipes offer the convenience of ready-to-use application. They are often used for cleaning surfaces and equipment, reducing the risk of cross-contamination.

Sterile Wipes: Used in environments where sterility is paramount, these wipes are gamma-irradiated and individually packaged to maintain sterility until use. They are essential for cleaning surfaces in pharmaceutical and biotech cleanrooms.

Microfiber Wipes: Known for their superior absorbency and particle entrapment, microfiber wipes are highly effective in removing both particulates and residues. They are ideal for final wipe-down procedures.

The role of ISO 3-4 Class 1-10 cleanroom wipes in contamination control cannot be overstated. These wipes are designed to eliminate contaminants that can compromise the integrity of cleanroom environments. Here’s how they contribute to maintaining cleanliness standards:

Particle Removal: ISO 3-4 cleanroom wipes are highly effective in capturing and removing particles from surfaces. Their low-linting properties ensure that they do not shed fibers, which could introduce new contaminants.

Surface Cleaning: These wipes are used to clean work surfaces, equipment, and tools, ensuring that any potential contaminants are removed before they can affect cleanroom operations. This is especially important in ISO 3-4 environments where even the smallest particles can cause significant issues.

Consistent Performance: The materials used in these wipes are selected for their consistency and reliability. This ensures that each wipe performs to the same high standard, providing confidence in the cleaning process.

When selecting ISO 3-4 Class 1-10 cleanroom wipes, certain qualities are essential to ensure they meet the stringent requirements of these environments:

Low Linting: The wipes must be low-linting to prevent the shedding of fibers, which could introduce new contaminants into the cleanroom.

High Absorbency: Effective cleanroom wipes should have high absorbency to efficiently capture and hold contaminants, ensuring thorough cleaning.

Chemical Compatibility: These wipes must be compatible with the cleaning solutions used in cleanrooms, maintaining their integrity and effectiveness.

Sterility Assurance: For sterile environments, the wipes must be sterilized and packaged in a way that maintains sterility until use. This is crucial for preventing microbial contamination.

Durability: Cleanroom wipes should be durable enough to withstand rigorous cleaning processes without tearing or disintegrating.

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  1. Comprehensive Product Range: End-to-end solutions, including facility consumables & equipment, wipers, PPE, disinfectants, and more.
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  4. Consistent Quality & Reduced Risk: You’ll get consistent quality. We understand the critical nature of cleanroom environments and ensure all products are appropriately packaged and handled to prevent contamination.
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  6. An industry leader for over 20 years, backed by a century-old parent organization known for its innovative vision and strategically located distribution footprint.

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