Our Development Sciences laboratories provide a flexible environment that accommodates a multitude of processing activities, from compounding bulk solutions ranging from a few milliliters to forty liters, to finished product characterization. Critical areas for component preparation, solution filtration, along with filling, stoppering and lyophilizer loading and unloading operations are all within a certified Class 100 (ISO 5) HEPA air supply environment to emulate aseptic operations for typical for processing sterile products. Contact us to learn why this is vital to your product, even in the development stage.
Preparation, processing and finished product evaluation are completed by qualified scientists and technicians following predefined methods and procedures. The study preparation is conducted to adhere to general principles and applicable guidelines of current Good Manufacturing Practice as published in the Code of Federal Regulations, 21 CFR, Parts 210, 211, 600, and 820.
Processing equipment and instrumentation are qualified for the operational parameters required for conducting development studies, and flexibility in processing a variety of products in a wide range of container/closure configurations.