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Celeste's Analytical Laboratory is cGMP compliant and is designed to enable efficient, compliant
testing of incoming raw materials, and in process and finished goods. Celeste can transfer
available methods or develop and validate HPLC and GC methods following the International
Conference on Harmonization Guidances for the Validation of Analytical Methods. Our microbiology laboratory ensures that this critical attribute can be monitored in house with a quick turnaround for Total Plate Count and required speciation activities. We routinely monitor the quality of our Purified Water, USP, system to ensure that it meets all required compendial methods. In addition, Celeste offers stability testing for compatibility studies and shelf life studies. Our chambers are validated to provide 25 °C/60% RH and 40 °C/74% conditions. By offering on-site stability testing, we can reduce the time to market on products by providing full scale up, method development and validation, process validation, and stability studies in house. This ensures a consistent approach to your scale up and marketing data. |
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