In the empty capsules manufacturing sector, the cleanliness of the production environment directly impacts drug quality and patient safety. As a benchmark enterprise in the empty capsule industry, KornnacCaps has always upheld a Zero-Defect goal, controlling production risks from the very source. A critical part of this is the standardized procedure for employee entry into the production workshop. This article unveils KornnacCaps' Five-Step Clean Access Protocol, showcasing the company's ultimate pursuit of detail in empty capsules safety.
Step 1: Changing into Clean Work Shoe, Isolating External Contaminants
Before entering into the production area, employees must change into dedicated clean work shoes in a designated zone. While this step may seem simple, it is fundamental to blocking external pollutants like dust and bacteria from being carried into the workshop on shoe soles. KornnacCaps uses anti-static, easy-to-clean specialized shoe materials, which are regularly disinfected and replaced to ensure their cleanliness meets GMP (Good Manufacturing Practice) standards.
Step 2: Second Dressing Room, The First Layer of Protection from Outside to Inside
Upon entering into the first dressing room, employees must remove personal outerwear, accessories, and other non-clean items and place them in a dedicated locker to prevent the introduction of external pollutants. Subsequently, they must strictly follow protocols to don a work cap (ensuring all hair is completely covered) and a mask (covering the mouth and nose). They then pass through a buffer zone for the initial hand washing and disinfection. KornnacCaps uses medical-grade disinfectants combined with the Seven-Step Hand-washing Technique to thoroughly eliminate transient bacteria on hands, building a solid foundation for subsequent operations.
Step 3: Second Dressing Room, The Sterile Donning Standard for Clean Garments
In the second changing room, employees must put on sterilized clean garments. KornnacCaps has strict regulations for the order of dressing: Top to Bottom, put on the top first and secure the cuffs, then put on the trousers, ensuring the body is completely isolated from the outside environment. The clean garments are made from special, anti-static, low-lint fabric and are collected daily for centralized cleaning and sterilization, eliminating the risk of cross-contamination.
Step 4: Second Shoe Change and Hand Disinfection, A Double Insurance in the Details
At the shoe changing cabinet, employees must put on disposable sterile shoe covers over their clean work shoes, providing an additional layer of isolation against any potential residual particles on the shoe soles. Afterwards, they pass through another buffer zone for hand disinfection with an alcohol spray, which quickly kills any bacteria that may have been acquired during contact. Through this dual protection of Shoe Covering + disinfection, KornnacCaps minimizes the probability of contamination to the lowest level.
Step 5: Air Shower, The Final Checkpoint Before Workshop Entry
After completing the above steps, employees must pass through an air shower. The air shower uses high-velocity rotating nozzles to release clean air, blowing 360° around the body's surface to effectively remove dust, hair, and other particles attached to the clothing. Only after a 30-second air shower and confirmation that cleanliness standards are met can employees officially enter the production workshop.
Forging Quality with Standards, Guarding Safety with Details
KornnacCaps' workshop access protocol is not just a mandatory requirement for complying with GMP standards; it is a profound practice of the company's Quality-First philosophy. From changing shoes and garments to the air shower, every step embodies a deep reverence for pharmaceutical safety. It is this ultimate control over details that has earned KornnacCaps the trust of global clients, establishing it as a quality benchmark in the hollow capsule industry.
Looking ahead, KornnacCaps will continue to provide high-quality capsule products to the pharmaceutical industry with its stringent production standards and advanced management systems, safeguarding the medication safety of every patient. Choosing KornnacCaps means choosing the assurance of Zero Contamination, Zero Risk.
