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Standards

Pall SoloHill Particle Validation Standards support the training of human inspectors to validate manual and automated visual inspection methods and provide reliable control of particulate contamination in pharmaceutical processes.

SoloHill® Particle Validation Standards

SoloHill® Particle Validation Standards Challenge and Validate Manual and Automated Visual Inspection Methods

The need for reliable, efficient control of particulate contamination is continuously increasing. The unintentional presence of extraneous, mobile and undissolved particles in a parenteral solution must be detected and remediated as part of any robust pharmaceutical product quality program.

 

Pharmaceutical processes can include several sources of potential particulate contamination: shards from chipped glassware, fibers from clean room cloths, stainless steel shavings from the production area, and many more. Detection of these contaminants through manual or automated methods is necessary to ensure affected units never reach the clinic.

 

Pall SoloHill Particle Validation Standards support the training and testing of human inspectors and are designed to challenge and validate both manual and automated visual inspection methods. Ideally, automatic inspection machines and human inspectors should be tested using separate Particle Validation Standards for each potential type of contaminant in the manufacturing process. Automated inspection machines should also be tested with each glassware type, as particle behavior varies based on container configurations. Automated visual systems should be validated using the recommendations of the machine manufacturer or after any adjustments or modifications have been made to the system.

 

After investigating potential sources of material contamination, Particle Validation Standards may be selected which fairly represent those possible contaminants. Potential contaminants or conditions unique to each process may be included, such as overfilled and underfilled standards, plunger position standards, and blanks.

 

Manufactured under a robust ISO certified quality program, flexible options simulate a wide variety of potential contaminants. Projects are designed based on exact requirements for container type and closure, fill solution and volume, as well as particulate type, size and number. All particle validation standard kits are assembled by experienced lab technicians using HEPA-filtered laminar flow hoods. Standards are fabricated utilizing customer supplied containers and seals, thus minimizing potential variations due to glassware manufacturers.

 

The SoloHill Particle Validation Quality System is certified to rigorous ISO 9001:2008 and ISO 13485:2003 standards. All projects are completed using the skilled lab technicians highly experienced in validation standards production processes, including drug product handling. Projects are fabricated in dedicated labs with HEPA-filtered laminar flow hoods. There are semi-automatic inspection stations with Tyndall lighting. Precise particle sizing is traceable to the National Institute of Standards and Technology (NIST).

 

There is a Certificate of Compliance and Traceability provided for all projects. Additional documentation, including a Certificate of Measure for individual particles, is available upon request. Lead times depend on the project specifics such as quantity ordered, particle sizes, and resource availability. Lead times are custom-quoted for each project.

 

Pall Corporation provides SoloHill® Particle Validation Standards to challenge and validate manual and automated visual inspection methods. For more information, click here.