ATUSA
Alpha Tech USA (ATUSA, LLC) is a company dedicated to providing validation services for the FDA-regulated industry, with a focus on pharmaceutical inspection systems for particle and cosmetic defects. They also fabricate cosmetic and particulate test standards (defect sample sets or control sets). The company has over 40 years of combined experience in full life cycle validation services, emphasizing excellence, ethics, and commitment to their customers and patients.
Industries
Nr. of Employees
small (1-50)
ATUSA
Mckinney, Texas, United States, North America
Products
Defect sample sets (control/test standards)
Physical test-standard sets that reproduce cosmetic and particulate defects for use in validating and benchmarking inspection systems.
Defect sample sets (control/test standards)
Physical test-standard sets that reproduce cosmetic and particulate defects for use in validating and benchmarking inspection systems.
Services
Validation planning, protocol development, execution and documentation for manufacturing and packaging equipment used in FDA-regulated production, including inspection systems.
Design and manufacture of control/test-standard sets that simulate cosmetic and particulate defects for use in inspection testing and process validation.
Assistance with completing an RFQ and specifying configuration requirements for custom defect sample sets; customers are asked to submit a form via email to request a custom set.
Validation planning, protocol development, execution and documentation for manufacturing and packaging equipment used in FDA-regulated production, including inspection systems.
Design and manufacture of control/test-standard sets that simulate cosmetic and particulate defects for use in inspection testing and process validation.
Assistance with completing an RFQ and specifying configuration requirements for custom defect sample sets; customers are asked to submit a form via email to request a custom set.
Expertise Areas
- Equipment validation for pharmaceutical manufacturing and packaging
- Inspection system performance evaluation and qualification
- Test-standard (defect sample set) development and fabrication
- Process validation and benchmarking for manual and automated inspection
Key Technologies
- Automated visual/optical inspection systems
- Defect sample set/test-standard fabrication
- Inspection performance benchmarking
- Equipment qualification and validation protocols