Sterile API Capabilities

Containment room one can handle batch sizes ranging from hundreds of grams to 25 Kg, specifically for Highly Potent APIs (OEB 4 and OEB 5). This process is conducted within a Grade C clean area that encompasses various critical stages: dissolution using a 500 Liter system, sterile filtration, recrystallization in a 500 Liter setup, and subsequent particle size reduction utilizing Frewitt granular machines and jet mills. The clean area also includes facilities for product filtration, drying, and packaging materials cleaning and sterilization.

For Sterile API and Excipients, we manage batch sizes from hundreds of grams to 25 Kg, with a maximum exposure limit of OEB 3. This line also operates within a Grade C clean area, featuring similar key processes: dissolution in a 500 Liter system, sterile filtration, recrystallization using a 500 Liter setup, and particle size reduction through Frewitt granular machines and jet mills. Additionally, this area supports product filtration, drying, and the cleaning and sterilization of packaging materials. Both lines adhere to stringent cGMP standards to ensure the highest quality and safety of our APIs and excipients.