BioPhorum Drug Substance Closed Systems in Controlled Non-Classified Workstream has recently published its room classification model article in the July/August 2021 edition of the PDA (Parenteral Drug Association) journal.
The paper outlines an assessment process to assist biopharmaceutical companies in assigning an appropriate grade of cleanroom during the early stage of design (e.g., concept design phase) in drug substance manufacturing facilities.
Generally, organizations’ design facilities based on previous experience. Improvements in equipment design and operation, especially the use of closed systems, allow certain process steps to take place in controlled environment areas rather than in classified cleanrooms. However, the design of facilities has not developed to reflect these advancements. This means that facility designs are more complicated with higher costs to build and operate than necessary. The model facilitates a logical, scientific risk-based approach to enable fast selection of the environmental conditions required for the different process steps early in the design phase of a project. This allows organizations to assign the appropriate room classification to a process step, rather than based on previous experience, expectations or on extrapolated interpretations of current GMP (Good Manufacturing Practice) guidelines, which do not reflect current technological advancement and best practice.
The risk assessment model supports the use of closed systems and demonstrates the limited need for classified areas. With fewer classified rooms, companies can reduce the complexity of facility layout and save costs without compromising patient safety or product quality. This will help create a paradigm shift in facility design and use of closed systems in Controlled Non-Classified space.