As anyone involved with cleanrooms knows, efficient and effective maintenance of these spaces is critical in healthcare and life sciences manufacturing, including biotechnology, pharmaceutical, and medical device manufacturing—and no wonder! Even the tiniest foreign particulate can cause a breach, compromising product quality and leading to potential health hazards, production delays, plant shutdowns, or even expensive class action and other product liability lawsuits. This is why the cleanliness of cleanrooms is heavily regulated. It is also why having a commercial cleaning services provider with cleanroom cleaning expertise is essential.
According to the International Organization for Standardization (ISO) 14644, the standard that regulates cleanrooms, a cleanroom is “a room in which the concentration of airborne particles is controlled and which is constructed and used in a manner to minimize the introduction, generation, and retention of particles inside the room.” In other words, cleanrooms are spaces where even submicron-sized particles and microbes cannot be allowed to remain. Hospitals and healthcare settings have cleanrooms to protect patients with compromised immune systems. Cleanrooms are also found in food, life sciences, electronic, medical device, and other manufacturing facilities.
Good Manufacturing Practices (GMP) are vital to manufacturing, and proper sanitation and hygiene play an enormous role in GMP. So, too, does the cleanroom’s International Organization of Standardization (ISO) number, which determines the level of cleanliness required.
The Good of GMP
GMP is a system of processes, procedures, and documentation designed to ensure products are consistently manufactured according to set quality standards. GMP protects consumers from defective, potentially dangerous products, and while GMP standards can vary by sector and even facility, strict adherence to them cannot.
ISO Levels of Cleanliness
A cleanroom’s ISO level of cleanliness is based on the amount of particulate allowed in the room per cubic meter. ISO levels range from 1 through 9, depending on the room’s usage, with 9 being the “dirtiest” cleanroom and 1 the cleanest. An ISO 9 standard can harbor up to one million micron-sized particles per cubic meter. ISO 1 demands 1,000 or fewer micron-sized particles per cubic meter. Most cleanrooms fall between ISO 5 and 8, with ISO 7 and 8 being the most common.
The Right Stuff
Meeting the strict GMP and ISO requirements for cleanrooms—and avoiding the costly consequences of not following them—requires a cleaning team familiar with proper cleanroom protocol. With this in mind, below are five areas where an experienced cleanroom cleaning service provider can prove invaluable.
Product knowledge. “Servicing a clean room requires knowing what equipment and products to use, such as the special wipers or the right formula mix,” explains Luis Ramirez, president of Shine Facility Services. “This is especially important when there is a breach. The cleaning product that must be used depends on the type of breach; the cleaning formula needs to work against the specific bacteria or substance that has entered the clean room. The scientists test the cleanrooms and let us know if there is a breach and what it is. Then we work with our supplier to ensure we get the right product. And even if you use the right product, if you don’t mix it correctly, you may not remove the breach.”
According to Ramirez, a breach can be caused by anything as seemingly simple as a person entering the room with jewelry, a cell phone, or an unauthorized cleaning product to an employee wiping perspiration from his/her forehead and touching a surface.
Processes. Another reason cleanroom cleaning is considered a specialty is that it requires a specific cleaning sequence. “Our GMP cleaners know where to start and end with their cleaning procedures to prevent cross and recontamination of surfaces,” Ramirez says. “Using the right sequence gets a cleanroom up and running faster after a product switch or breach and avoids the time and expense of do-overs.”
Staffing. Ramirez says clean rooms are usually serviced by teams of two or four. “Suppose there are not enough trained employees to cover an unforeseen employee absence,” Ramirez says. In such cases, manufacturing facilities can be forced to halt production, which can prove expensive and trigger long-term effects including supply chain shortages and canceled orders. At Shine, we have created a culture where people want to work, which breeds loyalty and reduces employee absenteeism and turnover.”
PPE and lifestyle. Ensuring all individuals entering a cleanroom wear full personal protective equipment (PPE), such as gloves, gowns, safety glasses, bonnets, and booties, is vital. Proper procedures for donning and removing PPE also must be strictly followed by all who enter the room, including cleanroom cleaners. “It takes a certain type of person who doesn’t mind working in full PPE,” Ramirez says. “Some people find it too restrictive, even claustrophobic. Some say it causes them to perspire, or they don’t like the feel of it. Others don’t want to remove their jewelry or give up wearing makeup or carrying their cell phones. We make sure to select technicians who are comfortable with these demands while possessing the temperament and patience to don and remove PPE often multiple times per shift.”
Attention to detail. Cleaning every centimeter of the same space, sometimes numerous times during a breach or product switch, can be tedious and monotonous. So, too, is the detailed reporting required every time a cleanroom is cleaned. “GMP requires a record of any actions taken, and it must be kept current at all times,” Ramirez says. “If an impromptu audit is conducted, and the records aren’t 100% up-to-date, the production can and will be shut down. It takes a special kind of person to perform these duties accurately and consistently.”
These are just five reasons hiring a commercial cleaning services provider well-versed in cleanroom processes and protocols saves time, money, and potential headaches. Contact us to find out more!
The Shine Difference: California’s Experienced Cleanroom Cleaning Service Provider
Are you seeking a cleanroom cleaning provider in the San Francisco Bay area with GMP and ISO-level knowledge and experience? We are experts in cleanrooms for healthcare, life sciences, and other manufacturing industries. Discover the Shine difference. Browse our website and contact us for more information or to get answers to your cleanroom or other facility maintenance questions. At Shine Facility Services, we take care of the cleaning so you can concentrate on running your business.