Pharmaceutical Automation Equipment Testing

SYRINGE SAMPLE

Prime Results produces blinded Data Matrix coded defect test sets for our clients. Defect sets in a pharmaceutical company include the following:

• Training inspectors

• Qualifying inspectors

• Defining defect definitions

• Sensitivity studies

• Knapp studies

• Challenge sets for machines

• Semi-automatic machine testing

• Automated machine testing

The Prime Results facility includes an aseptic clean room where all sample prep work is performed. There is a Laminar flow hood located in the clean room where all open container work is done.

During the process of making particulate defect sets, each seeded contaminant is fully documented for material and size prior to placing it into the container. After seeding, each sample is placed on a high-speed spin automated inspection test stand to verify the particle is freely moving in the liquid.

Defect sets are the backbone of automated inspection system management. They are used to determine the feasibility of using a specific inspection method, to set the performance requirements, and many more functions. Prime Results has assembled a defect set program that incorporates all of the guidance in USP 1790. With blinded Data Matrix coding and a logical numbering system, automated processing of test results is simplified.