GMP Facility Design

Kymanox has been designing GMP facilities since its inception. We provide upfront facility design layouts and partner with other engineering firms to produce facility permit drawings. In addition, we offer assistance with facility location selection. Kymanox have produced the conceptual designs for a wide range of GMP manufacturing buildings: Pharmaceutical (Solid and Liquid Dosage); sterile and non-sterile fill; label and …

Process Validation

Current Good Manufacturing Practices (CGMPs) enforced by the FDA require that all manufacturing processes be validated. Validation ensures that controlling the inputs (i.e. parameters) within an acceptable range will consistently produce outputs (i.e. products) of acceptable quality. The current FDA view of CGMPs emphasizes a risk and science-based approach to biopharmaceutical manufacturing. As a result, Process Validation is viewed as …

Data Logging & Mapping

We have all bought something that didn’t quite work the way we wanted. We get home, we set it up, and in the end, we get a dose of disappointment. Hopefully it can be returned and all we have wasted is time. However, in the world of compliance, a piece of equipment that does not work the way it needs …