Page 111 - Assurance of Sterility for Sensitive Combination Products and Materials

Package/container closures 95

Fig. 5.5 Prefilled injector pens. iStock.com/Kuruan

product to avoid expensive changes later in the process. A complete require-
ments definition must be developed for the development of a packaging
system. Careful identification of ‘packaging design inputs’ such as technical
requirements, user needs, and ‘packaging design outputs’; acceptance crite-
ria, specifications, and drawings need to be documented. This is followed
by packaging design verification where laboratory performance tests are
conducted to confirm the design inputs meet the design outputs. Finally,
packaging design validation is conducted to provide objective evidence that
design meets the user requirements [23, 24, 32–35].

5.3 Validation principles

5.3.1 Validation and patient safety
Health-care-associated infections (HAIs) continue to be one of the high-
est frequency adverse events in the delivery of health care. Achieving and
maintaining sterility of medical devices or combination products with an
adequate SBS while at the same time facilitating the aseptic presentation
during use are key factors in the fight against HAIs. To this end, the design
of a SBS must be carefully planned and validated. The forming, assembly,
and sealing or closure processes must be developed reliably through valida-
tion. Validation is a crucial activity for establishing, securing, and maintain-
ing sterile conditions since sterility of the device, the medicinal product, or