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发表于 2024-9-2 15:53:36
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本帖最后由 tingting021212 于 2024-9-2 15:59 编辑
有点多，你看看你有哪些，谢谢！
1 "Industry perspective on a holistic container closure integrity approach to parenteral combination products" ELSEVIER
2 "A Vial Container Closure System Performance Optimization Case Study Using
Comprehensive Dimensional Stack-Up" 非PDA
3 "Container Closure Integrity of a Glass Prefillable Syringe in Deep Frozen Storage" 非PDA
4 "Risk Mitigation of Plunger-Stopper Displacement Under Low Atmospheric Pressure by Establishing Design Space for Filling-Stoppering Process of Prefilled
Syringes: A Design of Experiment (DoE)" 非PDA
5 "Vacuum decay container/closure integrity testing technology. Part 2. Comparison to dye ingress tests" 非PDA
6 "Pharmaceutical container/closure integrity. III: Validation of the helium leak rate method for rigid pharmaceutical containers" PDA
7 "Pharmaceutical container/closure integrity. I: Mass spectrometry-based helium leak rate detection for rubber-stoppered glass vials" PDA
8 "PDA comments: container and closure integrity. Parenteral Drug Association" PDA
9 "Pharmaceutical container/closure integrity. IV: Development of an indirect correlation between vacuum decay leak measurement and microbial ingress" PDA
10 "Development of a Dye Ingress Method to Assess Container-Closure Integrity
Correlation to Microbial Ingress" PDA
11 "Development of a Dye Ingress Method to Assess Container-Closure" PDA
12 "valuation of a container closure integrity test model using visual inspection with
confirmation by near infra-red spectroscopic" PDA
13 "Vacuum Decay Container Closure Integrity Testing" PDA
14 "Vacuum Decay ContainerClosure Integrity Testing Technology. Part 2. Comparison to Dye Ingress Tests" PDA
15 "Vacuum decay container/closure integrity testing technology. Part 1. ASTM F2338-09 precision and bias studies" PDA
16 "Vacuum decay container closure integrity leak test method development and validation for a lyophilized product-package system" PDA
17 "Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at -80 {degrees}C" PDA
18 "Mass extraction container closure integrity physical testing method development for parenteral container closure systems" PDA
19 "High-voltage leak detection of a parenteral proteinaceous solution product packaged in form-fill-seal plastic laminate bags. Part 2. Method performance as a function of heat seal defects, product-package refrigeration, and package plastic laminate lot" PDA
20 "High-Voltage Leak Detection of a Parenteral Proteinaceous Solution Product Packaged in Form-Fill-Seal Plastic Laminate Bags. Part 3. Chemical Stability and Visual Appearance of a Protein-Based Aqueous Solution for Injection as a Function of HVLD Exposure" PDA
21 "White Paper: Container Closure Integrity Control versus Integrity Testing during
Routine Manufacturing" PDA
22 "Non-destructive vacuum decay method for pre-filled syringe closure integrity testing compared with dye ingress testing and high-voltage leak detection" PDA
23 "Impact of Vial Capping on Residual Seal Force and Container Closure Integrity" PDA
24 "Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial" PDA
25 "Influence of Different Container Closure Systems and Capping Process Parameters
on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product" PDA
26 "Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation" PDA
27 "Holistic Considerations in Optimizing a Sterile Product Package to Ensure
Container Closure Integrity." PDA
28 "Evaluation of Container Closure System Integrity for Storage of Frozen Drug
Products: Impact of Capping Force and" PDA
29 "Time-Dependent Testing Evaluation and Modeling for Rubber Stopper Seal" PDA
30 "ontainer Closure Integrity Testing-Method Development for Freeze-Dried Products Using Laser-Based Headspace Oxygen" PDA
31 "Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System" PDA
32 "Quantifying the Vial Capping Process: Residual Seal Force and Container Closure" PDA
33 "How to Qualify Container Closure Systems for Intended Use, Part 1" PDA
34 "Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of
(High Potent) Parenterals" PDA
35 "Long-Term Study of Container Closure Integrity of Rubber-Glass Vial Systems by
Multiple Methods" PDA
36 "Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)" PDA
37 "Time Temperature Superposition Evaluation and Modeling for Container Closure
System's Seal Performance at Low" PDA
38 "Validating Container Closure Integrity with Statistically Based Tests." PDA
39 "Container Closure Integrity Test Using Frequency Modulation Spectroscopy
Headspace Analysis with Carbon Dioxide as a Tracer Gas" PDA
40 "A Multicompany Survey Study for Helium Leak Container Closure Integrity Test" PDA
41 "Container Closure Integrity of Vial Primary Packaging Systems under Frozen Storage Conditions: A Case Study" PDA
42 "Leakage Dynamics of Glass Bottles on Container Closure Integrity Testing:
Influence of Different Laser-Drilled Microhole" PDA
43 "Assessment of Functional and Physical Performances of Pre-filled Syringes in Deep
Cold Storage Conditions" PDA
44 "Container closure integrity testing and process validation of closed system transfer devices for aseptic reconstitution of drug vials connected to fluid bags" PDA
45 "Comparing Container Closure Integrity Test Methods - Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls" PDA
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