Formulation and filling are important parts of any drug manufacturing process and demand the highest quality and reliability. A set of technologies and services that allow the end-user to manage their operations with greater reliability and flexibility, ensuring product quality in the manufacturing process. The use of disposable wallet technology, sterilization filters, and automated solutions ensure that manual interventions are minimized and a greater guarantee of sterilization is achieved.
This process requires advanced technologies and machines in a highly controlled aseptic environment. Fill finishes must meet strict requirements to ensure low sterility and integrity, ensure operational safety and efficiency, and ensure fill volume accuracy. Traditional filling/finishing machines are presented as fixed systems composed of complex components that require assembly, cleaning, and sterilization, disassembly, and storage of the material after a filling is completed. These operational steps provide an open escape route, allowing for the possibility of contamination or non-sterility and exposing operators to hazardous materials. Time pressure and piston pump systems are the main dosing and filling methods.
Requires confirmed formulation, open roads and clean-in-place (CIP), and/or steam-in-place (SIP) protocols to ensure a high probability of sterile end products on low roads. Due to the extensive use of stainless steel components, traditional filling and finishing systems are considered inflexible. This results in long response times and high operating costs due to CIP, SIP, labor, and factory costs. Validation of cleaning and sterilization processes; long and laborious setup; Validation and training of procedures to ensure the repeatability of a process contributes to creating a bottleneck when the time to market is critical.
The nature of these fixed systems is at odds with a rapidly changing market. Smaller groups, increasingly diverse product portfolios and increasing pressure to cut costs and get to market faster are not compatible with traditional filling and finishing equipment.