All Ingen Technology products are made in California with the following features:
- ISO 13485 certification
- CE certification
- FDA registration
- Strict GMP compliance
- State-of-the-art manufacturing equipment
- Medical class clean rooms (Class 10,000 and Class 100,000)
- Trained and highly skilled workforce
- Engineering and R&D team
- Experienced management team with commitment to quality, excellence, and service
Manufacturing capabilities include, but not limited to:
- Tubing molding
- Injection molding
- Insert molding
- Blow molding
- Radio frequency (RF) sealing
- Ultrasonic welding
- Aseptic filling
- Steam sterilization
- Assembly in clean rooms
- Form fill seal packaging
- Laboratory testing
- Device design & development
- Reverse engineering
- ETO sterilization
Quality Assurance Programs
Ingen Technologies has implemented and maintains an effective, stringent, and rigorous quality assurance system. Quality assurance plays a key role with full adherence to Good Manufacturing Practices (GMP) on a daily basis.
All products are manufactured in strict accordance with the GMP Regulations and ISO standards. All parts, components, and materials used in manufacturing are received, stored, and handled in a manner consistent with our high quality standards and are manufactured, assembled and packaged in air-filtered, temperature-controlled clean rooms, free from contamination. Temperature, humidity, air pressure, air filtration, and lighting are all strictly controlled to ensure uniform environmental condition and is inspected on a regular basis. Personnel sanitation rules are strictly enforced, and sanitized clothing is required for entrance to clean rooms. Measures are taken to prevent contamination of equipment, components, and finished products by cleaning agents and other chemicals. All products are stored in clean, well-maintained warehouses.
All quality audits are performed by trained personnel not having direct responsibilities for the products being audited. Audits results are documented in written audit reports, and reviewed by management responsible for the products audited. Follow-up corrective action, including re-audit of observed deficiencies, is taken when indicated.
Ingen Technologies values its commitment to quality and prides itself on its Quality Assurance Programs.