Contamination control is vital for maintaining cleanroom environments. Pharmaceutical and semiconductor companies require especially stringent maintenance and sanitation programs to meet demanding standards for air quality, room design, and operation, such as those set by the International Organization for Standardization (ISO). ISO 14644-1, which defines guidelines for the classification of air cleanliness determined by the permissible particle size and levels of concentration, forces manufacturing facilities to maintain high standards for a contaminant-free facility to protect their equipment, products, and employees. Operational costs, long-standing cleaning procedures, and lack of proper equipment can stymie a company’s efforts to build a comprehensive maintenance program.
Ultimately, this can create opportunities for contaminants to enter cleanrooms and negatively impact operational efficiency, employee health and safety, and the company’s bottom line. Facilities can significantly reduce the risk of contamination, however, by utilizing HEPA-filtered, portable industrial vacuums for general maintenance and hazardous material spills. These vacuums are integral tools for ensuring a cleanroom is free of contaminants and for reclaiming active pharmaceutical ingredients (APIs).
Portable industrial vacuums are effective tools for cleanroom applications that require personnel to safely remove contaminants from controlled environments. Any foreign matter, typically particulate, that detracts from a product’s performance is considered a contaminant, and traditional processes for cleanroom facilities focus on preventing one of three categories: airborne, fluid, or transfer particulates. While wipe-down methods and dusting systems are common practice, vacuuming is an efficient and effective method to thoroughly clean these environments.
Improving cleaning efficiency
Vacuums with high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filtration systems help cleanroom personnel better control factors that contribute to sterile environments. When included in maintenance procedures, these vacuums keep particles safely contained after removal and ensure optimal air quality. From collection through to disposal, they also protect users from potent compounds and offer the flexibility to clean remote areas efficiently (i.e., hard-to-reach areas, overhead spaces, in and around equipment). Portable industrial vacuums are designed to safeguard cleanrooms and improve a company’s approach to controlling contamination from personnel, materials, and machinery. Toxic compounds and other contaminants can be very small particles, which makes collecting airborne particulates an extremely difficult and timely process. Particulates align with the flow of the air stream and can easily penetrate porous filter media. However, HEPA filters capture 99.97% of particles as small as 0.3 microns and ULPA filters collect 99.999% of material down to 0.12 microns. Trapping matter of this size significantly improves air quality and upholds the integrity of cleanrooms.
As part of a regular maintenance program, vacuums keep particles safely contained and ensure optimal air quality.
Vacuum filtration to mitigate risk
Industrial-strength vacuum cleaners featuring a superior filtration system with HEPA or ULPA filters offer the level of sanitation cleanrooms require. Depending on the size of particles, a multi-stage system is an important line of defense for protecting filters from blockage and excessive wear and tear, maintaining peak performance and, most importantly, preventing contaminants from recirculating into the air. The key to graduated filtration is a series of progressively finer filters which trap and retain particles as they travel through the vacuum.
While companies cannot absolutely omit all potential sources for unwanted matter, they can mitigate risk by investing in reliable, efficient cleaning equipment. Portable industrial vacuums easily remove and dispose of contaminants with minimal risk to users. Personnel have a safe means for cleaning hazardous materials spills and the ability to quickly and easily address sanitation concerns. Facilities that invest in multiple vacuums can also specify one vacuum per application, further eliminating the potential for cross-contamination or accidents. A filtered exhaust stream is also vital for collecting fine particles like dust and powder. Vacuums should have “upstream” and “downstream” filters installed before and after the motor to capture particulates from its airflow and exhaust stream. “Upstream” filters also protect the motor and extend the vacuum’s lifespan, while a “downstream” filter captures dust from the motor’s commutator and carbon brushes.
Maintenance and cleaning programs should facilitate simple sanitation and validation processes for cleanrooms. A portable industrial vacuum, made out of non-particle-generating materials such as stainless steel, eliminates the chance for contamination by the vacuum itself and helps cleanroom personnel meet critical standards for contamination control. Oversized main filters slow airflow across large surfaces so that the vacuum can capture larger volumes of debris during use. As a result, vacuums run more efficiently for longer time periods and optimize air-to-cloth ratios for easy, efficient cleaning.
Applications for cleanroom maintenance
When hazardous materials are a concern in cleanrooms, portable vacuum cleaners can greatly assist in the clean-up and disposal of these materials. Removable collection containers offer the ability to collect, contain, and dispose of potent compounds without coming in contact with toxic materials. Bag-in/bag-out systems are beneficial as well, because they facilitate the safe replacement of HEPA filters.
A stainless steel vacuum eliminates the chance for contamination by the vacuum itself and helps cleanroom personnel meet contamination control standards.
Cleaning machinery and equipment is an important step in contamination control. Residual dust and powder can collect in machines and on equipment surfaces, posing a health and safety risk. By integrating portable vacuums into process equipment, cleanroom personnel can thoroughly remove particles directly from the source and reclaim valuable compounds and APIs. Vacuums with a small, compact design provide flexibility for processing environments with limited space. Furthermore, if multiple vacuums are used, facilities can streamline cleaning procedures, increase efficiency, and establish proper protocol for maintaining a cleanroom’s integrity.
Sources of contamination
Despite rigid industry standards and comprehensive cleaning programs, some elements of contamination prevention are beyond a company’s control. Pharmaceutical production facilities that require cleanroom environments often develop procedures around three major sources of particles: cleanroom materials, equipment, and personnel. Comparatively, the most common source of contaminants is personnel.
While materials like gowns and gloves provide a layer of protection for skin, hair, and clothing, humans can transmit unwanted matter into these environments in other ways. For example, sneezing or simple movements like sitting or walking can lead to organic material entering the air supply. Typically, a working person generates about one million organic airborne particles that are greater than 0.5 microns per minute.
Investing time and resources into educating personnel about maintenance procedures and why certain precautions are necessary can significantly improve the integrity of cleanrooms. Key factors to address include:
• Personal hygiene
• Proper gowning materials and techniques
• Particulate behavior
• Government standards and protocols for cleanrooms
Providing quality cleaning equipment and necessary training in the use of tools like portable vacuums can also prevent discrepancies in cleanroom maintenance. Cleanroom personnel will not only be empowered to efficiently maintain the environment, but they will also actively prevent costly missteps that can have serious consequences.
Pharmaceutical and semiconductor manufacturing facilities face unique cleaning challenges that, if not addressed, can negatively impact their products, their employees, and their overall success. Controlled environments require thorough cleaning to remain free of potent compounds and hazardous materials. Establishing proper protocols for contamination control and combining vacuuming with manual procedures will create a much more effective process for maintenance and sanitation. As part of a comprehensive cleaning program, portable industrial vacuums should feature multi-stage filtration systems, wet/dry capabilities, and safe collection units. Taking these steps in cleanroom maintenance will mitigate risks for contamination and allow personnel to easily address hazards across various applications.
Rob Decker provides technical support to customers and the Nilfisk Industrial Vacuum sales force for product and application-specific inquiries and modifications. He develops, designs, and manages special vacuum modifications and accessories for unique applications and/or customer requests. Rob joined the Nilfisk team in 2006. Nilfisk Industrial Vacuums is a division of Nilfisk-Advance Inc., Morgantown, Pa. Nilfisk Industrial Vacuums supports three brands—Nilfisk, Nilfisk CFM, and Nilfisk ALTO—that provide industrial vacuums to manufacturing and industrial facilities. www.nilfiskindustrialvacuums.com.
This article appeared in the May 2013 issue of Controlled Environments.