Aligning Consumables to Your Specific Cleanroom Needs

Cleanroom consumables vary by type and grade. Always choose consumables that match your environment’s cleanliness needs. Using items not designed for stringent spaces can compromise contamination controls. Below are examples of how to select the right quality for your requirements:

Wipers – Material & Cleanliness Class: Wipes are made from various materials, ranging from inexpensive nonwoven blends to ultra-clean polyester knits. Generally, the lower the ISO cleanroom class (indicating a cleaner environment), the more stringent the properties of the wipers should be. For example, in an ISO Class 4 sterile filling suite (Grade A/B area), it is recommended to use a 100% polyester knit wipe with sealed edges, as it offers the lowest particle generation. These wipes are often laundered and packaged in high-grade cleanroom conditions (ISO Class 4) and sterilized when used for aseptic processing.

In contrast, in areas classified as ISO Class 7 or 8 (less critical background or support zones), a polyester-cellulose nonwoven wipe can be utilized. This option is more economical and absorbent, and a bit more lint is acceptable in these areas. In non-critical cleaning tasks or lower-grade labs (ISO Class 8 and above), even cotton or foam wipes may be suitable. Although cotton has great absorbency, it tends to shed fibers, so it’s generally reserved for applications where the risk of particle contamination is low, or where cotton will be thoroughly removed after use.

The table below illustrates how wipe choices might align with a cleanroom class:

Cleanroom Environment	Example ISO Class	Recommended Wipe Type
Aseptic filling line (sterile API)	ISO 4-5 (Class 10-100; Grade A/B)	Polyester or microfiber knit, sealed-edge, sterile. Ultra-low lint and gamma irradiated.
General prep area (non-sterile formul.)	ISO 6–7 (Class 1,000–10,000)	Poly-cellulose blend nonwoven, cut-edge. Low lint but higher sorbency for less critical cleaning.
Support / gowning area	ISO 7–8 (Class 10,000–100,000)	Possible use of cotton or foam wipes for heavy spill absorption. (Not used on critical surfaces; ensure no fibers remain.)

*(Above: Examples of matching wiper materials to cleanroom classes, based on industry recommendations.)

It is essential to verify that any selected wiper is appropriately rated for the specific cleanroom class in which it will be deployed. The use of the wrong wipes in lower-class environments undermines contamination control efforts; for instance, nonwoven “lint-free” wipes that have not been laundered are unsuitable for ISO 5 pharmaceutical hoods or isolators, as they may introduce particles and fibers. In such critical settings, only laundered, ultra-clean knitted wipes should be utilized.

Gloves: Just like wipes, gloves used in cleanrooms come in various grades. For ISO 5/Class 100 applications, such as aseptic manufacturing or compounding, gloves are typically clean-processed (washed) and double-bagged for easy entry into the cleanroom. They may also be sterilized for aseptic use.

It’s important to note that standard boxed gloves, even if labeled as “sterile,” are not suitable for ISO 5 environments. This is because particles can shed from the cardboard box and the gloves themselves, which can contaminate the area. Instead, sterile cleanroom gloves are individually packed or come in cleanroom-compatible packaging—without cardboard—and are often validated to be low-lint and free of powders.

Cleanroom gloves (including nitrile and latex) are available in different cleanliness levels. For example, some are labeled for ISO 3–5 use, indicating they have undergone extra cleaning and are packaged in ultra-clean materials, while others are intended for ISO 6–8 use, which means they are clean but not as rigorously processed.

Always choose gloves that are appropriate for your specific environment and task. Remember, “sterile” is not enough; the glove must also be “clean.” Regulators have observed cases where “sterile” gloves that were not clean-processed introduced contamination due to carrying particulate matter. Therefore, for critical pharmaceutical operations, it is essential to use gloves that are both cleanroom-grade and sterile, and that come with a Certificate of Sterility and analysis.

Apparel (Gowns, Coveralls, etc.): Cleanroom garments are a prime example of why quality matters. These suits serve as the barrier between personnel and the clean environment. High-quality cleanroom apparel is made from non-shedding synthetic fabrics (no cotton!) with a tight weave to prevent fibers from releasing. Common materials include reusable polyester filament fabrics and disposable polyolefin (e.g., SMS polypropylene) suits—both designed to be lint-free and ultralow in particles.

Additionally, these garments should resist collecting particles to ensure they can be effectively laundered and dissipate static to avoid attracting contaminants. Many life-science cleanrooms today require sterilized garments for Grade A/B operations. This entails that coveralls, hoods, boots, and other pieces, after being manufactured and cleaned, are individually packed and gamma-sterilized. Using sterile garment packs is crucial to prevent the introduction of bacteria or fungi during the gowning process.

It’s also essential that gowns fit well and are worn correctly; an ill-fitting or improperly donned suit can release particles. High-quality garments often feature bound seams (to contain filaments), thumb loops (to ensure sleeves stay under gloves), and low-lint zippers. They typically come with training from the vendor on proper gowning techniques.

All of these factors contribute to the ultimate goal of keeping human contamination out of the cleanroom. Quality gowns and strict gowning protocols work together to achieve this objective.

Other Consumables: Every item introduced into a cleanroom must be carefully evaluated for quality and contamination risk. This includes sticky mats, swabs, cleaning tools, paper, and labels. For instance, cleanroom swabs are available with polyester or foam heads that won’t shed fibers, unlike cotton swabs, which could be disastrous in a microelectronics cleanroom.

Cleanroom paper is another specialized product; it is made from low-linting pulp and impregnated with polymers to ensure that writing in a cleanroom does not generate paper fibers or static. When using tacky mats at entrances, choose low-residue types that won’t leave adhesive on shoe covers and ensure they are appropriately sized to capture debris effectively.

Mops and cleaning buckets also require careful consideration—select cleanroom-compatible mops, preferably with microfiber heads that do not shed, and choose either autoclavable or disposable options. In pharmaceutical facilities, many prefer disposable mop heads and wipes to eliminate the risk of cross-contamination between areas. Using a fresh, sterile mop head for each cleaning session helps to prevent the spread of contaminants.

Additionally, ensure that mop handles and wringers are made from non-corroding, easily cleaned materials such as stainless steel or plastic, as rust or paint chips have no place in a cleanroom.

The key takeaway from these examples is to use tools specifically designed for cleanrooms. When in doubt, it’s better to opt for higher quality. A single overlooked instance of shedding or residue leaching from inadequate consumables can lead to significant problems down the line.

 

In Review:

• Cleanroom consumables should always match the cleanliness level and requirements of the specific environment—using lower-grade items in higher-grade areas can introduce contamination risks.
• Key consumables like wipers, gloves, and garments must be selected for their material, cleanliness, and packaging, ensuring they are clean processed, sterilized, and properly documented for critical applications.
• All tools and consumables, from swabs to mop heads, must be designed for cleanroom use, as even a single instance of fiber shedding or residue can compromise contamination control and regulatory compliance.