Thawing/formulation & pooling /filtration

This activity introduces the key aspects of the formulation process, including the components (active substance, excipients, adjuvants), safety and stability constraints, and regulatory requirements. It illustrates the steps of thawing, weighing, and the management of formulation equipment.

This activity simulates the execution of an aseptic formulation. It covers gowning in a controlled environment, component selection, thawing, weighing, ingredient introduction, mixing, sterile filtration, and temporary storage, while applying the requirements of the batch record and aseptic best practices.

This activity presents the different types of samples to be taken during formulation to ensure the product’s compliance, quality, and safety.It details in-process controls (IPC) such as pH and osmolality, as well as tests performed by Quality Control (QC) such as bioburden and sterility.