Page 9 - Assurance of Sterility for Sensitive Combination Products and Materials

Foreword xiii

bioburden-based methods that are increasing in importance due to envi-
ronmental as well as product compatibility reasons.
The chapter on aseptic processing lays out a prudent strategy focused on
aseptic processing and sterility by design. It introduces the powerful line-
of-sight process control approach which leads to robust user requirements.
Practical aseptic practices and environmental monitoring cleanroom design
approaches are discussed, including aseptic barrier systems, e.g., isolators,
and critical utilities. Practical process simulation design guidance is recom-
mended using case studies to illustrate the principles. The chapter ends with
a discussion of quality risk management and risk-based critical thinking
and an overview of new technologies and perspectives in the field of aseptic
processing.
The essential aspects of sterile combination product packaging and con-
tainer closure design are explored in chapters as an essential means to the
maintenance of sterility throughout the storage, handling and use. Microbial
barriers, packaging sterilization compatibility, labeling, and storage/trans-
port requirements for materials and package components are provided.
Design and development requirements are delineated, along with those for
aseptic presentation. Packaging system performance and stability require-
ments are then discussed along with validation requirements.
A key chapter focuses on the fundamental concepts of hospital-acquired
infection (HAI) and the related issues surrounding the handling and use of
health-care products. This topic is critical in the discussion of the overall
sterility risk to the patient and alternate ways to determine sterility as-
surance levels. An analysis of the breakdown and rates of HAIs enables an
understanding of the relative magnitude of these issues. By discussing the
root causes of HAIs-principally related to clinical personnel and practices,
and surveying case studies, prevention strategies can be determined and
recommended.
As members of the global health-care product community, our primary
objective is ensuring the health and welfare of patients. It is through the un-
derstanding of patient needs that new products are developed. It is through
identification of the required quality attributes of those products that pro-
cesses are designed. It is through recognition of the variables of those pro-
cesses that control strategies are employed. It is through the utilization of
innovative technologies that products are improved.
In this way, awareness of patient needs, product requirements, pro-
cesses variables, and available technology result in addressing today’s and