ISO 17025 Certification in Progress

 FDA/USP 1207.1 for Package Integrity Tests

 

Quality Policy

Lenox Laser’s management and employees are committed to quality and superior customer service. It is the responsibility of management and employees to promote principles of integrity and excellence in all they do. All Lenox Laser employees will systematically work towards achieving and maintaining compliance with the following objectives:

  • Continually improve our processes and the effectiveness of the Quality Management System.
  • Ensuring strict compliance with applicable regulations and international standards, with regard to Lenox Laser’s policies and procedures, and any applicable regulatory authority’s requirements.
  • Meeting the needs and requirements of our customers with the goal of better tolerance and precision on a wide variety of products.
  • Consistently providing quality services.
  • Ensuring that all of our personnel are certified and competent and have familiarized themselves with the quality documentation to implement the policies and procedures required in their work.

 

Optical Measurements

Standard Optical     Calibrated   
Thickness       0.0005″ – 0.002″ 0.0005″ 0.0005″
Tolerance * 5% 3% 3%
Certificate Yes

* Comparative tolerances are based upon similar 150 micron drilled products; tolerances may vary.

Standard Apertures

Parts are produced from foil with thicknesses of .0005” – .002”. Parts have a looser listed tolerance than Optical and Calibrated Apertures. Apertures are optically measured on instruments that are calibrated with Lenox Laser traceable bar chart standards. No certification is included.

Optical Apertures

Parts are produced from thin foil (.0005”). Parts have a tighter listed tolerance than the Standard Aperture. Apertures are optically measured on instruments that are calibrated with NIST traceable bar chart standards. No certification is included.

 

Calibrated Apertures with Certification

Parts are produced from thin foil (.0005”). Parts have a tighter listed tolerance than the Standard Aperture. A certificate of calibration is included. Parts will be labeled with aperture size. Apertures are measured for concentricity, circularity, and diameter. Apertures components are optically measured on instruments that are calibrated with Lenox Laser traceable bar chart standards. Parts are traceable to Lenox Laser standards.

 

 

Flow Measurements

Standard      Calibrated     Certified   
Optically Measured      Yes Yes Yes
Flow Calibrated Yes Yes
Certificate Yes

 

Standard Components

All standard orifice components are optically measured on instruments that are calibrated with Lenox Laser traceable bar chart standards. No certification is included.

Flow Calibrated Components

All flow calibrated components are measured on instruments that are calibrated with Lenox Laser traceable standards. The component’s packaging will be individually labeled with Part Description, Flow Direction, Flow Reading (SCCM, SLPM, TORR), size in microns, and date. Tolerances will be the same as listed. No certification is included.

Flow Calibrated Components with Certification

Any flow Validated component will be supplied with a Certificate of Validation report containing traceable standards used, test conditions, measurement results and inspection signoff.