In the production process of personal lubricants, the use of a Class 100,000 cleanroom has a crucial impact on product quality. A Class 100,000 cleanroom refers to a clean room where the number of dust particles with a diameter greater than or equal to 0.5 microns per cubic meter does not exceed 100,000. Such an environment is essential for manufacturing medical devices and products that require high levels of cleanliness.
1. Higher Cleanliness
A Class 100,000 cleanroom can significantly reduce airborne dust and microbes, thereby lowering the risk of contamination during the production process. This is particularly important for personal lubricants that come into contact with human mucous membranes, as they must maintain extremely high cleanliness to avoid causing infection or discomfort.
2. Strict Quality Control
In a Class 100,000 cleanroom, the production process is subject to strict monitoring and control, ensuring that each batch of products meets predetermined quality standards. This high standard of production environment helps improve product consistency and reliability, ensuring that every bottle of lubricant used by consumers meets the highest quality requirements.
3. Reduced Risk of Allergies and Irritation
Due to better control over production environment pollutants, personal lubricants produced in such environments can reduce the risk of allergies and irritation. This is an important consideration for users with sensitive skin.
4. Compliance with International Standards
A Class 100,000 cleanroom is one of the requirements of many international medical device production standards, such as ISO 14644-1, which classifies cleanrooms based on dust particle concentration. Personal lubricants produced in such workshops are more likely to gain recognition and trust in the international market.
Foshan Pingchuang Medical Technology Co., Ltd., as a professional OEM/ODM manufacturer of personal lubricants, has a production base with a 3,000 square meter Class 100,000 cleanroom. In this environment, Pingchuang Medical's personal lubricants not only meet domestic quality requirements but have also won authoritative certifications such as Class II medical device registration certificate, ISO13485, FDA 510K, and EU CE. These certifications and high-standard production environments ensure the excellent quality and safety of Pingchuang Medical's products, making it a trusted partner of well-known brands both domestically and internationally.
