Understanding Class 7 Cleanroom Requirements | Class C Cleanrooms

In industries such as pharmaceuticals, biotechnology, and electronics manufacturing, contamination control is paramount. Cleanrooms provide an essential environment where the number of airborne particles is regulated, ensuring product safety and quality.

In this article, we’ll dive into the requirements of ISO Class 7 cleanrooms, cover the cleaning basics, and provide insight into proper apparel and wipes selection to maintain cleanliness and efficiency.

What is an ISO Class 7 Cleanroom?

An ISO Class 7 cleanroom limits the concentration of airborne particles larger than 0.5 microns to 352,000 particles per cubic meter of air. This level cleanroom often used in medical device manufacturing, electronics manufacturing / assembly, and pharmaceutical packaging.

The key to maintaining an ISO Class 7 cleanroom is controlling contaminants from external environments, personnel, and internal processes. This requires not only appropriate filtration systems (like HEPA filters) but also rigorous cleaning protocols and specific apparel.

FED 209E and GMP EU Equivalents to ISO Class 7

ISO Class 7 cleanrooms are also recognized under other classification systems. The Federal Standard 209E, which is primarily used in the United States, equates an ISO Class 7 cleanroom to a Class 10,000 cleanroom. This means that no more than 10,000 particles (0.5 microns or larger) are permitted per cubic foot of air.

In the European Union, cleanrooms are classified under the GMP (Good Manufacturing Practice) standards, which focus on pharmaceutical manufacturing environments. The ISO Class 7 cleanroom aligns with GMP EU Grade C. This grade is used for environments where products are at rest, meaning the cleanroom is not in active operation, yet must still meet stringent particle control requirements.

ISO 7 Cleaning Basics

The cleaning process in an ISO Class 7 cleanroom is crucial to keeping particle levels within the allowable limits. Cleaning typically follows a top-down approach, starting with ceilings, followed by walls, and then floors. This method helps prevent re-contamination of surfaces already cleaned.

Ceiling and Wall Cleaning

For ceiling and wall cleaning, tacky rollers or extended-handle mops are frequently used to reach higher areas. In some cases, larger sized lint-free cleanroom wipes are used for more precise cleaning. It’s recommended to use dry wipes, but for more stringent cleaning, pre-saturated wipes with a solution of 70% Isopropyl Alcohol (IPA) and deionized water are effective. The right choice of wipes can significantly impact particle control and contamination prevention.

Floor Cleaning

Floor cleaning in a Class 7 cleanroom often involves mopping with cleanroom-compatible solutions and tools, such as autoclavable buckets and edgeless string mops. Sticky mats are also an essential tool to trap particles from shoes and wheels before entry into the cleanroom.

Wipes and Cleaning Supplies

The selection of wipes plays a critical role in maintaining cleanroom standards. In an ISO Class 7 cleanroom, poly-cellulose wipes are often recommended due to their low particle shedding and high absorbency. These wipes are ideal for general cleaning and wiping down surfaces where contamination control is necessary.

For applications that require enhanced cleanliness, such as sensitive electronic manufacturing, polyester knit wipes are preferred. These wipes are durable and provide a lower level of particle generation and chemical extractables, making them suitable for more stringent cleaning tasks.

Apparel Recommendations for Class 7 Cleanrooms

Proper cleanroom apparel is vital for minimizing contamination introduced by personnel. According to the recommended guidelines, personnel in an ISO Class 7 cleanroom should wear:

• Hair covers
• Beard covers (if applicable)
• Face masks
• Lab coats or coveralls
• Boot covers or shoe covers
• Gloves

While some cleanrooms may also require the use of goggles or face shields, the level of protection depends on the specific industry and the nature of the tasks performed.

The Role of Garments in Contamination Control

Cleanroom garments not only protect products from human contamination but also ensure the safety of the cleanroom personnel. For an ISO Class 7 cleanroom, disposable lab coats or coveralls made of materials like polypropylene are commonly used. These materials are breathable, lightweight, and low in particle shedding, making them a practical choice for medium-clean environments. For more demanding tasks, Tyvek suits offer a higher level of protection and durability.

Conclusion

Maintaining an ISO Class 7 cleanroom requires a comprehensive approach, from proper cleaning techniques to the selection of appropriate wipes and apparel. By adhering to best practices and utilizing the right tools, you can ensure that your cleanroom environment remains compliant and efficient.

Whether it’s wiping down surfaces with low-lint wipes, wearing proper apparel, or following a strict cleaning protocol, attention to detail is essential. If you’re in need of cleanroom wipes or apparel, make sure to choose products that meet the necessary standards for your specific cleanroom classification. With the right practices and supplies, contamination control becomes manageable, allowing you to maintain a clean, controlled environment for your products.