QUALITY YOU TRUST

At Acorn Industries, we understand that your quality specifications are critical to your manufacturing operation and ultimately to the safety of the patients. All our employees are engaged to meet and exceed the quality standards required for every product that comes out of our facility.

A dedicated Quality Assurance team ensures that Standard Operating Procedures (SOPs) are followed, and quality standards are met through predefined inspection processes that can be dialed in to customer needs. Our Quality Policy, Quality Manual, procedures, and validations are part of a documented system with batch record and production lot control through each step of the process.

Acorn follows cGMP guidelines, FDA guidance and USP monographs with respect to its processing and documentation practices. A Certification of Process and/or a Certification of Analysis will accompany each shipment.

Our cleanroom can provide internal testing for particulates (containers & closures in accordance with USP <788> and USP <789>, TOC (containers & closures and water system), endotoxin (water system), resistivity (water system) and complement with independent testing for sterility (containers & closures) and endotoxin/LAL (containers & closures).

Our team performs quality tests, inspections and certifications on-demand or based on customer specifications. We also support our customers for audits and regulatory submissions.

All products are inspected, packaged, sealed and labeled for shipping with full documentation, including certifications based on customer’s requirements. After cleaning, packaging is performed using aseptic techniques in our dedicated intimate packaging area cleanroom then packaged in the final packaging area after sterilization and drying.