Contributor: Myles Reukema, Senior Director Cleanroom Sales, Prudential Cleanroom Services
Cleanroom gowning is a crucial aspect of maintaining a clean and sterile environment to produce high-quality products. By following a strict set of guidelines, cleanroom gowning helps to minimize the risk of contamination from human skin, hair, and clothing. This is especially important in industries such as pharmaceuticals, electronics, and biotechnology, where even the slightest particle can have a significant impact on the final product. Proper cleanroom gowning ensures the safety of employees and customers, as well as the quality and reliability of the products being produced. Don’t underestimate the importance of cleanroom gowning — make sure your team is trained and following the proper procedures to ensure your products are of the highest quality. When it comes to cleanroom garments, it’s essential to use clothing that is specifically designed and approved for use in a cleanroom environment. These garments should be made of materials that minimize the shedding of particles and fibers, as well as being non-linting and non-shedding. Typically, cleanroom garments are made of synthetic materials such as reusable, polyethylene terephthalate (PET) or single-use polypropylene (PP) and single-use high-density polypropylene (HDPE) as these materials have a tighter weave and produce fewer particles than garments with natural fibers.
The level of cleanliness required in the specific cleanroom will dictate the gowning items necessary so you can create your gowning protocol.
Cleanroom garments include:
• Coveralls
• Hoods
• Goggles
• Boots
• Gloves
• Frocks
• Shoe covers
• Beard covers
• Bouffants
• Face masks
• Scrubs
In addition to extremely clean and particle-free gowns, many life science-sector cleanrooms require the outer garments to be sterile.
It’s vital to select garments that are appropriate for the level of cleanliness required and to follow the proper gowning procedures to ensure maximum effectiveness in minimizing contamination. Based on the applicable standards and practices, ISO recommendation per ISO Standard 14644-1 Classification of Air Cleanliness by Particle Concentration. For example, an ISO Class 5 Cleanroom is equal to FED-STD 209 Class 100 and approximately equal to EU Grade A. Common cleanroom classifications for pharmaceuticals, compounding, and medical device areas are ISO Class 8, ISO Class 7, ISO Class 6, and ISO Class 5 cleanrooms. To maintain a sterile environment in certain cleanrooms, it’s important to follow specific gowning protocols for aseptic manufacturing. These protocols are outlined for cGMP, USP <797>, USP <800>, or EU Annex 1, and are designed to ensure the safety and efficacy of the manufacturing process.
Establishing a suitable cleanroom gowning procedure is critical to maintaining the integrity of your products and ensuring the safety of your customers and colleagues. By prioritizing safety and quality, you can create a work environment that inspires confidence and trust, strengthening your commitment to excellence and the quality that catapults you forward.
Additionally, cleanroom environments require specialized equipment such as ULPA and HEPA air filters to ensure the air is clean and free of particles. Specific water is of great importance and USP purified water is needed to manufacture pharmaceuticals; for example, water for injection (WFI) USP sterile water for injectable drug manufacturing is a key component. Other products needed may include cleaning supplies, such as disinfectants and cleaning wipes, to maintain a sterile environment. Sterile reusable microfiber mop systems with one-step, precise touch-free mop wetting and discarding of the aseptic reusable mops are identified for dedicated usage locations to clean floors, walls, and ceilings. There are similar disposable single-use mops with a similar system and for the same surfaces. Isolator cleaning systems with reusable or disposable micro mop heads allow you to clean the hoods effectively and ergonomically; the need to reach all the way into the hood, shoulder deep, using your hand to wipe clean the inside of the hood potentially increases the risk of contamination compared improved methods and tools. Using these tools reduces the risk of contaminating the hood while cleaning.
It’s essential to select appropriate products that are for use in a cleanroom environment to ensure maximum effectiveness in minimizing contamination. Following the correct cleanroom protocols and using best-in-class cleanroom products like the items above will help to reduce contamination risk exponentially within your controlled cleanroom space. It is recommended that you contact expert consultants to help guide you in developing quality best practices in the management of your cleanroom process.
