Services
Learn more about what Agno Pharmaceuticals can do to help you accomplish your goals.
Cytotoxic API Production
Dissolution and Recrystallization
High-Potency API Production
Sterile Filtration and Drying
General Sterile API Production
Packaging Materials Cleaning and Sterilization
Our Sterile API Line Design
Each line at Agno Pharma is meticulously designed and maintained to ensure the highest levels of product integrity and safety, adhering to cGMP standards and providing reliable solutions for the pharmaceutical industry.
Sterile API Line 1
This line is designed for the production of cytotoxic APIs, handling batch sizes ranging from hundreds of grams up to 12.5 Kg. This line operates under OEB 4 and OEB 5 guidelines to manage the high potency of cytotoxins. The associated cytotoxic aseptic API production workshop is equipped with a Grade C clean area for critical processes including dissolution, sterile filtration, recrystallization, product filtration, and drying. Additionally, a Grade D clean area is designated for the cleaning and sterilization of packaging materials. Key equipment includes a 600 liter stainless steel dissolving tank, a 600 liter stainless steel crystallization tank, a capping machine within an isolator, a cleaning machine, a dryer, and a sterilization cabinet.
Sterile API Line 2
This line focuses on high-potency APIs (HPAPI), with batch sizes ranging from hundreds of grams to 25 kilograms, adhering to OEB 4 and OEB 5 standards. This line features a Grade C clean area for dissolution (500 Liters), sterile filtration, recrystallization (500 liters), and various processing stages including the use of a Frewitt granular machine and jet mill. The line also includes facilities for product filtration, drying, and the cleaning and sterilization of packaging materials.
Sterile API and Excipients Line 3
This line caters to both APIs and excipients, with batch sizes from hundreds of grams to 25 Kg, complying with ≤OEB 3 conditions. This line is equipped with a Grade C clean area for dissolution (500 Liters), sterile filtration, recrystallization (500 Liters), and additional processing with a Frewitt granular machine and jet mill. The line ensures rigorous product filtration, drying, and comprehensive cleaning and sterilization of packaging materials.
