Primary Validation Summary of Rapid-C+
as an alternative and rapid microbiological method
Our primary validation summary for Rapid-C+ is now available on request. This document provides a high level summary of Primary Validation for the the Rapid-C+ Online Air Monitoring System (PLAIR SA, Perly, Geneva, Switzerland), evaluated as an alternative and rapid microbiological method (ARMM) for real-time environmental monitoring. By comparing the alternative method to the established traditional monitoring method, it could be demonstrated that the method is at least equivalent to, or better than the traditional growth-based method, also expressed by the term “non-inferiority”.
This comprehensive validation addressed performance characteristics in accordance with USP 1223, Ph. Eur. 5.1.6, and PDA TR No. 33, including: Accuracy, Precision, Specificity, Limit of Detection, Limit of Quantification, Linearity, Range, Ruggedness, Robustness, and Equivalence. Request the full document via the link below.
