Quality Systems
Solésence is intensively focused on product quality, customers, and the Company’s total commitment to lean 6σ manufacturing and continuous improvement. With an internationally recognized quality system and operating its manufacturing facilities under FDA guidelines, Solésence has a distinct competitive advantage as a leading manufacturer of materials and finished goods. . Well-equipped Quality Assurance Laboratories assure outgoing product quality levels continually exceed customer expectations.
ISO 9000
The Company’s operations and facilities have been registered to the ISO 9001 international quality standard since 1997. The ISO 9001:2015 Quality Management System registration enables Solésence to demonstrate commitment to service quality and customer satisfaction, as well as continuously improve the quality management systems and integration due to the realities of a changing world.
cGMP
Solésence facilities conduct manufacturing operations under the FDA’s current Good Manufacturing Practices (cGMP). The Company is registered as a drug ingredient manufacturer and has been successfully inspected by the FDA. Key volume products manufactured for personal care are certified to the USP purity requirements.
GMP is designed to help assure the quality of drug products by ensuring several key attributes, including correctness and legibility of recorded manufacturing and control documentation. GMP also requires that all manufacturing and testing equipment be qualified as suitable for use, and that all operational methodologies and procedures (such as manufacturing, cleaning, and analytical testing) utilized in the drug manufacturing process be validated (according to predetermined specifications), to demonstrate that they can perform their purported function(s).
Download Solésence Quality Policy (Currently under Nanophase name during transition)
Download Solésence ISO 9001:2015 certificate (Currently under Nanophase name during transition)
Environmental Responsibility
Environmental Management
Solésence employs a systematic approach to streamline, monitor, control, and improve environmental aspects throughout our facilities and in the community.
Solésence facilities and practices are certified to ISO 14001:2015, the international standard for environmental management systems since 2005.
Solésence regularly participates with US and international organizations in leading efforts to develop and harmonize nanotechnology standards related to nomenclature, metrology, and Environmental Health and Safety.
Solésence is actively involved in reducing nanoparticulate chemical exposure to employees and the environment through the use of advanced Industrial Hygiene monitoring devices and techniques well beyond the standard regulatory requirements.
Regulatory Compliance
Solésence complies with all applicable federal, state, and local air, land, and water release requirements and maintains all required environmental permits.
Most environmental aspects associated with Solésence’s locations are regulated by the Illinois EPA, and the Solésence facilities have been regularly audited by the Illinois Environmental Protection Agency (IEPA). Environmental reporting is up to date and 100% compliant with all requirements.
An active Waste Management program is in place to control and reduce industrial waste. Solésence’s policies do not allow unauthorized releases of chemical waste streams into the air, land, or water.
Download Environmental Policy (Currently under Nanophase name during transition)
Download Solésence ISO 14001:2015 certificate (Currently under Nanophase name during transition)
Occupational Safety
At Solésence, we are committed to providing a safe workplace for our employees, a safe and effective product to our customers, and to being a responsible corporate citizen by protecting the environment.
Solésence facilities practice all applicable OSHA rules and regulations established for general industry. OSHA requirements along with prudent industry practices are integrated into a single Environmental Health & Safety and Quality Management System, which helps streamline workflow and provide greater focus.
Through frequent training and promoting safety awareness, Solésence minimizes or eliminates workplace incidents and injuries. Activities are continually measured by recording loss time accidents and near misses resulting in an extremely safe workplace.
REACH
REACH is a new European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorization and Restriction of Chemical substances. The new law entered into force on 1 June 2007.
SOLÉSENCE CURRENT PATH
- Posted OR notification on web.
- Completed Pre-Registration of metal oxide and other solvents, monomers, and dispersants.
- Received confirmation of Pre-Registration of proprietary dispersants/additives from suppliers.
- Ensure all substances shipped to Europe are compliant with REACH requirements under 1T/yr exemption or registered if import exceeds 1T/yr, for example, Zinc Oxide, Aluminum Oxide, and Iron Oxide
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