PDA 343.1 Single Use Systems for the Manufacturing of Parenteral Products

Determining the optimal manufacturing strategy involves concepts from many disciplines. An effective evaluation will have a balanced viewpoint with consideration from engineering, regulatory, quality project management and accounting. Balancing risks and rewards of a Single Use System (SUS) over a Multiple Use System (MUS) will help determine the most appropriate manufacturing strategy.

Based on PDA Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing, this training course will provide attendees with critical concepts to consider when implementing an SUS strategy in a pharmaceutical manufacturing process. These concepts are intended to be valid both for chemically synthesized, small molecules and for bioprocesses that produce large-molecule, biopharmaceutical products.

The training course will discuss SUSs that are in either direct or indirect contact with the raw materials, intermediates, intermediate products, pharmaceutical drug substances or drug products.

Participants will also receive a free copy of PDA Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing.

1. Describe the necessary considerations and steps to accomplish a successful evaluation and implementation of an SUS strategy
2. Define process operating parameters and requirements necessary when examining single use solutions
3. Compare and contrast single use technology and multi-use technology
4. Assess risk by considering the potential for the SUS to interact with product or process fluids
5. Outline supplier control strategies to ensure successful SUS implementation