The Parenteral Drug Association (PDA) released “Technical Report No. 62 (TR 62), Recommended Practices for Manual Aseptic Processes,” the association announced in a press release. The purpose of TR 62 is to outline methods and approaches for control and evaluation of aseptic processing operations for drug or medicinal products that use all or partially manual procedures.
TR 62 has value for hospital and formulation pharmacies where manual aseptic processing may occur. The guidance provided in this report may be applicable to operations including: vaccine preparation, cell culture, gene therapy, investigational new drug or medicinal product manufacturing, clinical and commercial manufacturing, and pharmacy formulation and dispensing. TR 62 is not intended to address the brief, relatively infrequent, human interventions into an otherwise automated filling process. Examples include reach-ins to remove a toppled vial from the filling line or to obtain a container for a fill-weight check, aseptic connections made during set-up, and corrective activities during line stoppages.