[Foreign Object Standards] Customized defect kit for verifying visual inspection processes for manual and automated processes.
Sartorius offers a wide range of customizable manufacturing standards designed to validate visual inspection processes used in quality assurance to address the challenges of detection through visual inspection. Sartorius's Particle Validation Standards (PVS) provide an economical and straightforward method to solve the time-consuming and complex task of creating standards in-house. They are also effective as training samples for manual inspection systems. ■ Supports reliable and efficient control against foreign matter contamination ■ Responds to customer needs with a wide lineup ■ Validation of visual inspection ■ For training inspectors ■ Economical and straightforward
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basic information
The presence of unintended, unrelated mobile undissolved particles in non-oral solutions needs to be detected and corrected as part of a robust quality program. The pharmaceutical process may include several potential causes of foreign contamination, such as fragments of broken glass products, fibers from cleanroom fabrics, and stainless steel shavings from production areas. Detection of these contaminants is necessary to ensure that affected units do not reach the clinic. Key System Functions ✔ Manufactured under a robust ISO-certified quality program ✔ Flexible options simulate potential contaminants ✔ Customized standards reflect the risks of the operational environment Utilizing our unique project matrix, the design is based on precise requirements for the types, sizes, and quantities of particles needed for each standard, in addition to closed-system filling solutions and volumes. All foreign matter standard kits are assembled by experienced lab technicians using HEPA-filtered clean benches, Eisai APK container inspection stations, and precise sizing of foreign matter traceable to NIST, minimizing potential variations from glass product manufacturers by utilizing containers and seals provided by the customer.
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Applications/Examples of results
Items included in the foreign matter validation criteria: ■ Glass balls and fragments ■ Fibers and hair ■ Rubber and plastic metals ■ Containers that are underfilled or overfilled ■ Physical scratches and surface damage ■ Blank (no foreign matter) NIST Traceable All foreign matter is measured using equipment validated by a stage micrometer traceable to the National Institute of Standards and Technology (NIST). Sartorius's PVS is also useful for the calibration of automatic inspection equipment.
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Company information
Sartorius Stedim, established in 2007 through the merger of the German company Sartorius, founded in 1870, and the French company Stedim, is a pioneer in "Single-Use Technology (SUT)." As a company capable of providing comprehensive technical support to the pharmaceutical and biotechnology industries, its cutting-edge technology is highly regarded worldwide in the fields of scientific instruments and biotechnology.
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