USP〈1382〉 ASSESSMENT OF ELASTOMERIC COMPONENT FUNCTIONAL SUITABILITY IN PARENTERAL PRODUCT PACKAGING/DELIVERY SYSTEMS

1. INTRODUCTION

2. EARLY PACKAGING/DELIVERY SYSTEM SELECTION AND DEVELOPMENT: FUNCTIONAL SUITABILITY ASSESSMENT CONSIDERATIONS

3. FINAL PRODUCT PACKAGING/DELIVERY SYSTEM FITNESS-FOR-INTENDED-USE SUITABILITY ASSESSMENT

4. GENERAL CHAPTER 〈382〉 BACKGROUND AND GUIDANCE

4.1 Test Samples

4.2 Test Sample Population Size

4.3 Packaging/Delivery System Integrity Tests

4.4 Needle and Spike Access Functionality Tests

4.5 Plunger Functional Suitability Tests

4.6 Tip Cap and Needle Shield Functional Suitability Tests

5. CONCLUSION

1. INTRODUCTION

This chapter contains information and guidance to assist in the functional suitability assessment of elastomeric components as part of packaging/delivery systems intended for parenteral dosage forms contained in Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems 〈382〉. Such components include primary packaging/delivery system components that are partially or completely made of elastomeric material. The proper selection and design of functional suitability assessment studies is based on sound and justifiable scientific principles provided in 〈382〉, 1. Introduction.

2. EARLY PACKAGING/DELIVERY SYSTEM SELECTION AND DEVELOPMENT: FUNCTIONAL SUITABILITY ASSESSMENT CONSIDERATIONS

Early in the packaging/delivery system selection and development process, the final packaging/delivery system and its components may not be fully defined and functional suitability requirements may not be established. This is especially true if the packaging/delivery system or the drug product is novel to the drug product applicant. At this phase of the product life cycle, functional suitability assessments are performed to better understand packaging/delivery system performance and/or to screen potential elastomeric component and container candidates. To that end, Table 1 lists elastomeric component functional suitability tests in standards published by the International Organization for Standardization (ISO). The list should not be considered all-inclusive. The most recent standards should be referenced.

The terms "standards" and "recognized standards" used throughout this chapter and 〈382〉 refer to those published by ISO.

Although not mandated, testing components and/or closure packaging/delivery systems according to such standards may provide useful information, especially during early product packaging/delivery system development. Other relevant internationally recognized standards deemed scientifically appropriate may be used instead of, or in addition to, those listed in Table 1. Standard test data may be made available by elastomeric component or packaging/delivery system suppliers.

Source from USP:https://online.uspnf.com/uspnf/document/2_GUID-B76F42B6-1DF1-45E6-83D3-265DD09AE33A_10101_en-US

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