Cleanrooms are vital to many businesses, particularly in industries requiring the highest quality control levels, such as pharmaceuticals and electronics manufacturing. In addition, third-party logistics (3PL) businesses that handle products within these industries also need to have cleanroom facilities to ensure the integrity of the products they handle.
However, installing a cleanroom can be complicated and costly, and one must consider many factors to ensure it meets industry standards. In this article, we will explore key considerations that 3PL businesses should consider when installing a cleanroom to ensure that it meets industry standards and efficiently facilitates operations.
1. Cleanroom Classification and Standards
Cleanrooms are essential for industries requiring contamination-free conditions to ensure product quality, such as pharmaceuticals, medical devices, and microelectronics. Cleanrooms are classified based on the maximum allowable number of particles per cubic meter and the maximum allowable size of particles.
The most widely recognized classification system for cleanrooms is the ISO classification system. The ISO standards define the maximum number of particles per cubic meter for each classification level. For example, an ISO 7 cleanroom must maintain a maximum of 352,000 particles per cubic meter. The ISO standards also define the maximum allowable size of particles for each classification level.
Classifying cleanrooms is essential because it allows companies to ensure that their products are in an environment that meets the required standards. It also allows them to provide documentation to regulatory agencies, demonstrating that their products were manufactured in a controlled environment.
Numerous companies offer cleanroom solutions, but American Cleanroom Systems’ ISO 7 cleanrooms stand out as one of the best in the market. It is attested by James, a senior medical device engineer, in the testimonial section of the company’s website. The company’s cleanroom systems are meticulously designed and manufactured to comply with the most rigorous industry standards.
2. Airflow and Filtration
Airflow and filtration play a crucial role in maintaining a contamination-free environment in eCommerce’s warehousing and fulfillment operations. Partnering with a reliable third-party logistics (3PL) provider ensures your products are stored and handled in a clean, controlled environment with the latest air filtration and ventilation systems.
Pharmaceutical 3PL providers often use ISO 7 cleanrooms that meet strict industry standards to ensure optimal airflow and filtration, helping prevent product contamination and maintain product quality.
According to Medline Plus, a High-Efficiency Particulate Air (HEPA) filter can effectively remove a wide range of harmful particles, including dust, mold spores, pet dander, dust mites, and other irritating allergens. It is achieved by installing HEPA filters that remove particles as small as 0.3 microns.
Proper airflow and filtration are critical to maintaining the integrity of the products handled or manufactured in the cleanroom. Therefore, it is important to ensure that the cleanroom is designed and installed by professionals with expertise in cleanroom technology to meet industry standards.
3. Cleanroom Materials and Surfaces
Maintaining a clean and contamination-free environment is vital for eCommerce businesses. One way that third-party logistics (3PL) providers ensure this is by using specialized materials and surfaces in their cleanroom facilities.
The walls, ceilings, floors, and surfaces of the cleanrooms are constructed with materials that are easy to clean, durable, and resistant to corrosion, ensuring they remain free from contamination.
When choosing materials for flooring and surfacing, epoxy flooring is the best solution. It is an excellent choice for improving any surface’s durability, sustainability, and appearance.
It offers a smooth, long-lasting finish that enhances the load-bearing capacity of the floor, as mentioned by an engineering company, Daily Civil. Using epoxy flooring also helps promote a clean and safe environment for workers, equipment, and inventory.
Overall, the materials and surfaces used in a cleanroom must be carefully selected to ensure they meet industry standards and are compatible with the cleanroom’s classification.
4. Equipment and Furnishings
Third-party logistics (3PL) providers must use state-of-the-art equipment and furnishings specifically designed to meet the needs of cleanroom environments. These include specialized storage systems, material handling equipment, and conveyor systems designed to prevent product contamination and ensure maximum efficiency.
The type of cleanroom equipment varies from company to company depending on the product they manufacture or pack.
For example, if the cleanroom is used for pharmaceutical products, the temperature is critical. The equipment used for maintaining temperature is crucial. According to Monnit, for a compounding pharmacy, it is essential to maintain a working environment with a temperature range of 20 to 25°C (68 to 77°F). It not only promotes stability in materials but also ensures comfort for employees.
All equipment and furnishings for 3PL cleanrooms must be designed and constructed to minimize particle generation and shedding, be easy to clean, and be appropriate for the cleanroom’s classification and intended use.
5. Personnel and Safety
Cleanroom personnel are crucial in ensuring that the cleanroom meets industry standards. They must be properly trained in cleanroom procedures, including gowning, hand hygiene, and cleanroom behavior. In addition, personnel must be aware of the cleanroom’s classification and understand the potential risks associated with the materials and processes used within the cleanroom.
To maintain the cleanliness of the cleanroom, personnel must be vigilant in adhering to the cleanroom procedures. It includes proper gowning procedures, including wearing appropriate cleanroom garments, gloves, and footwear and following proper hand hygiene practices.
3PL personnel must also be trained on cleanroom behavior, including proper movement within the cleanroom, avoiding touching surfaces unnecessarily, and reporting any potential contamination incidents immediately.
Proper training of cleanroom personnel and ensuring that appropriate safety measures are in place can help to prevent accidents and contamination incidents within the cleanroom. A professional cleanroom installation company can guide cleanroom personnel training and safety measures appropriate for the cleanroom’s classification and intended use.
To Wrap it Up
In conclusion, cleanroom installation is critical for 3PL businesses that handle sensitive materials, such as pharmaceuticals, medical devices, and electronics. By following industry standards and guidelines, 3PL businesses can ensure that their cleanroom meets the requirements for the safe and effective handling of these materials.
When considering cleanroom installation, evaluating factors, such as airflow and filtration, cleanroom materials and surfaces, equipment and furnishings, personnel and safety, and maintenance and monitoring, is essential.
By working with a professional cleanroom installation company, 3PL businesses can ensure that their cleanroom is designed and constructed to meet the appropriate classification and standards and that they have the necessary protocols and procedures in place to maintain the cleanliness of the cleanroom over time.
By carefully considering the key factors involved in cleanroom installation and working with a reputable and experienced installation company, 3PL businesses can ensure that their cleanroom meets industry standards and provides a safe and effective environment for handling sensitive materials.