Page 96 - Assurance of Sterility for Sensitive Combination Products and Materials

Package/container closures 83

5.2.2 Packaging functions
The function of all packaging systems is to:
1. Protect the product from the environment during sterilization process-
ing, transport, and storage,
2. Communicate about contents and how to safely use the product, and
3. Interface with user to facilitate usage.
The protection of the product from the environmental assaults is a key
function of packaging. This includes physical/chemical protection from ele-
ments such as mechanical shock, vibration, electrostatic discharge, compression,
temperature, light, humidity, and atmospheric pressure changes. Secondary
packaging such as corrugated containers provides additional protection during
distribution and handling. Tertiary packaging is used for bulk handling, ware-
house storage, and transport shipping. The most common form is a palletized
unit load [22]. Packages and labels also communicate how to use, transport,
recycle, or dispose of the package or product. Packages often have features
that interface with the user during distribution, handling, stacking, display, sale,
opening, re-closing, use, dispensing, reuse, and recycling. The packaging is typ-
ically the first interaction the user has with the product [23–26].
A critical design feature of medical packaging is to enable the user to
successfully deliver the product to the sterile field aseptically while mini-
mizing the risk of infection to the patient. For overall risk management, it
is important to formally include and evaluate also other usability features
like label readability, product identification, etc., in addition to the opening
feature, during the design process of a medical packaging system (refer to
“Clinical use: aseptic technique and usability aspects”).

5.2.3 Differences between requirements of medical device
and pharmaceutical packaging

The objective for SBSs for medical device products and pharmaceutical
packaging is to ensure that the product remains safe and efficacious. The
pharmaceutical and medical device industries have arrived at this solution
independently, therefore, it’s not surprising that their approach to achieve
the same goal is different. Medical devices utilize the ISO 11607 series of
documents while pharmaceuticals are guided by the various pharmacopeias.
The medical device standard, ISO 11607-1 for medical packaging, de-
lineates requirements into four areas:
• qualification of materials for safety and performance;
• assessment for sterilization compatibility (see Table 5.1 for material
compatibility with various sterilization methods);