“The Development of an Isolator-Based Flexible Filling System for all Containers”
Primary parenteral packaging has, for years, been produced in bulk and sold to pharma companies, where the bulk packaging was washed, sterilized, filled and sealed. This arrangement required different types of processing and filling equipment at the pharma companies for each type of primary container. Recent advances and cooperation between primary container suppliers and equipment manufacturers have led to a robust line of primary containers and closures that are ready to use and can be accommodated by a single flexible filling and closing system. This new paradigm in primary parenteral packaging pushes more responsibility back to the suppliers of the packaging, provides a higher quality primary container for the pharma companies, reduces the pharma companies’ capital expense for processing and filling equipment and creates more of a partnership between the pharma company, the primary container supplier, and the equipment manufacturer. Ultimately a superior and safer packaged drug product is prepared to the patient.
Berkshire Sterile Manufacturing (BSM), has worked with several equipment manufacturers to design a flexible clinical-scale filling line that is able to utilize vials (bulk or nested ready to fill), pre-filled syringes, nested ready to fill cartridges and custom containers such as is provided by primary container suppliers like Nouva Ompi. The system is based upon nested primary containers which leads to many advantages such as reduced glass handling (fracturing and bruising), less “handling” of components in washing and sterilization, reductions in particulates, and reduction in capital and validation costs. The advantages and considerations with these systems will be described to allow others to capitalize on these new formats that bring safer and more flexibility to drug development and commercial manufacturing.