US CFR Article 21: Article 21 of the US Federal Regulations contains the rules and regulations promulgated by the US Food and Drug Administration (FDA). Ultra Clean products used in food and beverage processing, as shown in the parameter table, meet the 21st clause. More specifically, they comply with Article 21, Section 170-199, Subchapter B, ‘Food for Human Consumption’, which lists the list of permitted food additives and related restricted materials. The FDA compliance of Ultra Clean related products includes component supplier evaluation, testing and third-party legal opinions. A brief version of the relevant legal opinion is available upon request.
EC Reg. Nos. 1935/2004 and 10/2011: This regulation is promulgated by the European Union (EU) and is suitable for materials and articles that contact food. Ultra Clean products used in food and beverage processing, as shown in the parameter table, comply with 1935/2004 and 10/2011, including component supplier evaluation, testing and third-party legal opinions. A simplified version of the EU certification statement and legal opinion are available on request.
Halal: Halal means “approved” for food in accordance with Islamic law. Ultra Clean products used in processed food, as shown in the parameter table, comply with the Halal certification of a third-party organization. Halal product certification is available on request.
3-A is the standard of living: Jointly issued by the 3-A Sanitary Standards Corporation, the United States Department of Agriculture (USDA) and other organizations, these standards provide standards for the selection, design, and manufacturing of dairy processing equipment. USDA’s Agricultural Market Service (AMS) uses this standard, combined with independent inspections and grading services, to determine whether the equipment is suitable for dairy products. KMS products used in dairy processing are in compliance with 3A sanitary standards and ‘standard 45-02: cross-flow membrane modules’.
USP: The United States Pharmacopoeia (USP) is a pharmaceutical standard issued by the United States Pharmacopoeia Commission. Ultra Clean’s ROMIPRO and SPIRAPRO product components have passed the tests and certifications of third-party laboratories, and comply with the biological testing and elution test of USP Class VI plastic products.
Structural exclusion of electrophoretic paint materials: Ultra Clean designs and manufactures electrophoretic paint ultrafiltration systems in accordance with the equipment specifications of “structural exclusion materials for electrophoretic paint systems”. All parts do not contain silicon and specific metal materials that can cause coating defects.
Ultra Clean’s commitment to quality is not only reflected in the products and services provided, but also in our strategic policy through the implementation of the ASQ/ANSI/ISO 9001 quality management system (QMS). Ultra Clean’s total quality management method provides a solid structure and foundation for improving overall efficiency and organizational performance. Our quality management system has further improved our ability to meet the requirements, needs and expectations of users and stakeholders.
The Ultra Clean quality control system is well documented and managed to ensure goal communication and consistent actions. In the production process, we have combined lean production methods to improve our operational efficiency and productivity. Ultra Clean is committed to “quality starts from the source”. Strict quality control combined with relevant industry standards penetrates into every step of the production process from raw materials to finished products. Statistical program control is applied to key tests to ensure our production control and product consistency. All Ultra Clean employees are trained and authorized to ensure their safety and deliver our products and services on time with quality and quantity.
