INTERTEK

  • home
  • INTERTEK
  • 용기적합성평가(MFDS)

USP 1665

〈 1665 〉 CHARACTERIZATION OF PLASTIC MATERIALS, COMPONENTS, AND SYSTEMS USED IN THE MANUFACTURING OF PHARMACEUTICAL DRUG PRODUCTS AND BIOPHARMACEUTICAL DRUG SUBSTANCES AND PRODUCTS



UNDER CONSTRUCTION




1. INTRODUCTION

2. SCOPE

3. GENERAL PRINCIPLES

3.1 Discussion

3.2 Material Characterization and Selection 3.3 Extractable Elements Testing for Materials

3.3.1 Cured Silicone Materials

3.4 Biological Testing of Materials

3.5 Component Characterization and Selection

4. CHARACTERIZATION PROCESS

4.1 Initial Assessment

4.2 Risk Assessment of Components

4.2.1 Risk Evaluation Matrix

4.2.2 Development and Application of the Risk Evaluation Matrix

4.2.3 Linking Risk to Characterization Methodologies

4.3 Establishing the Level of Component Chemical Characterization

4.3.1 Low Risk Assessment

4.3.2 Moderate Risk Assessment

4.3.3 High Risk Assessment

4.4 Standard Extraction Protocol

4.4.1 Extraction Solutions

4.4.2 Extraction Temperature

4.4.3 Extraction Duration

4.4.4 Accomplishing the Extraction

4.4.5 Non-Standard Extractions

4.4.6 Accounting for Conditioning and Related Steps Employed in Manufacturing

4.5 Testing the Extracts and Generating the Extractables Profile

4.6 Evaluation of the Extractables Profile Established by Implementing the Standard Extraction Protocol 4.7 Establishing the Level of Component Biological Testing

5. QUALIFICATION OF MANUFACTURING SYSTEMS

5.1 General

5.2 Chemical Qualification

GLOSSARY APPENDIX

An Example of a Risk Evaluation Matrix