Page 64 - Assurance of Sterility for Sensitive Combination Products and Materials

Aseptic processing 51

• wrapping, holding, and assembly of sterilized product contact parts;
• wrapping, holding, and transfer of sterilized components, and
containers;
• holding and transfer of sterilized product;
• sanitization materials entering the clean room areas;
• product sterilization and transfer;
• product container closure integrity;
• attachment of lines, filters, tanks, vessels, hosing, etc.
• pre-sterilization solution compounding;
• cleaning, sanitization, and sterilization of takes, vessels, filters, and
lines;
• cleaning, sterilization, and depyrogenation of components;
• cleaning and sterilization of parts;
• sterilization or filtration of product;
• container closure sealing and integrity; and
• inspection of filled units.
• Aseptic processing activities
• inherent and corrective interventions;
• environmental monitoring practices and techniques;
• environmental monitoring sampling plans;
• clean room personnel supervision and observation;
• aseptic technique and first air principles;
• clean room personnel rest periods, breaks, fatigue, ergonomic process
design;
• personnel personal hygiene and illness recognition;
• clean room gowning and personnel monitoring;
• reporting of discrepancies and deviations; and
• exclusion or restriction of materials, personnel, items, and such from
clean room.
These process steps and actions are essential in the holistic approach to
aseptic process validation. All equipment supporting the process should be
qualified and each process should be validated.

4.11 Interventions and activities in the aseptic processing
critical area

Interventions usually are human activities or manipulations that occur
during the aseptic process in the proximity to product contact surfaces. This
poses a risk to product quality especially aseptic process performance. In
general, because people represent a significant source of bioburden, human