Validation Equipment Rental

High-precision equipment comes with a high price. Validation requires the ability to accurately record data, and it is not always cost or time efficient to purchase your own validation equipment. Whether you have an internal validation team or need assistance from a trained staff, Kymanox can support your project. Kymanox rents out calibrated, high-precision equipment for temperature mapping. We have …

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 …

Facility, Utility, and Equipment Qualification

When starting up a new manufacturing area, the qualification of systems that support the drug production process (facilities, utilities, and equipment) is essential to ensure patient safety and product quality, and to meet regulatory requirements and business needs.  Qualification must be done quickly and correctly so the area can be used for production. In the life science industry, missing one …

Cleaning Validation

In 1988, Cholestyramine Resin USP finished drug product (a cholesterol medication) was recalled due to cross-contamination with low levels of an agricultural pesticide.  The contamination was a result of a lack of validated cleaning procedures and inadequate control of recovered solvent drums. This recall reinforced the need for validated cleaning procedures to prevent cross-contamination. The FDA provides detailed information regarding …