Introduction Lyophilization is commonly used in the pharmaceutical and biotech industries to improve stability and shelf life of parenteral dosage forms. The scope of molecules that are typically lyophilized include proteins, peptides, oligonucleotides and liposomes. Introduction (cont.)

No one test is appropriate for all packages or for all leak testing applications. Selection criteria for package integrity test methods, as well as method comparison aids, are presented to guide the user in the selection process. First Supplement to USP 39–NF 34 General Information / á1207ñ Package Integrity Evaluation—Sterile Products 1

The selection of the appropriate container closure integrity testing (CCIT) method depends on the requirements and purpose of the test. The factors considered while deciding the appropriate CCI test method include sensitivity and reliability of the test method, material of the primary package and inline versus offline testing requirement.

Jun 7, 2023 · Container closure integrity, as an important critical quality attribute, is a measurement of the ability of a container closure system to prevent contamination (e.g., microbiological ingress), sustain sterility, and maintain DP stability. Container closure integrity testing (CCIT) has been recognized as having a significant impact on batch yield.

Apr 1, 2018 · The appropriate selection of adequate primary packaging, such as the glass vial, rubber stopper, and crimp cap for parenteral products is of high importance to ensure product stability, microbiological quality (integrity) during storage as well as patient safety.

Mar 25, 2020 · When evaluating the storage of product at -80°C, it is important to select a suitable container closure system for the secured storage of gene therapy products at cryogenic temperatures. These results of this study suggest that the two types of vials (2R and 6R) in combination with the tested stoppers and plastic push-fit caps (RayDyLyo

The test method used is only one of the major considerations in approaching the challenge of proving an integral system. This paper takes a holistic review of all the major considerations needed in qualifying a new vial system for container closure integrity. There is substantial interplay among many aspects in the process of sealing a vial.

Feb 1, 2016 · Container closure integrity Process control 1. Introduction Parenteral drug products are protected by appropriate primary packaging components. The most commonly used primary packaging for parenteral drug products to date is the rubber stopper and glass vial, sealed with an aluminum crimp cap.

4. package integrity 5. needle and spike access functionality tests 5.1 fragmentation 5.1.1 vial packages 5.1.2 bottle packages 5.1.3 bfs containers with plastic caps that have inserted elastomeric liners 5.1.4 dental cartridge packages and pen-injector packages 5.1.5 needle-based injection system packages 5.2 penetration force 5.2.1 vial packages

LC Vial Selection uide 5 Vials 1.5mL MT-IT Clear Center Draining w/Screw Cap 1.5mL MT-IT Amber Center Draining w/Screw Cap 1.5mL MT-IT Clear Center Draining w/o Caps 1.5mL Certified* LabTotal Vial for MS w/ Screw Cap 200uL Q-sertTM fused insert w/ Screw cap 200uL Q-sertTM fused in-sert w/Snap cap 300uL Polypro-pylene w/ Screw cap

This article is the second in a series describing vial crimping and capping equipment selection and the qualification necessary to create a well-closed sealed vial in a Current Good Manufacturing Practice environment to ensure patient safety and maintain compliance.

Apr 25, 2023 · For lyophilization applications, the selection of the primary container system (i.e. vial, stopper, seal) must be given careful consideration in order to avoid surprises in the later stages of development and potentially costly issues throughout the product’s life cycle. The system must provide a sterile barrier, enable robust fill/finish and

VI. VII. GUIDANCE FOR INDUSTRY1 Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products This guidance represents

In addition, we compared two large-scale good manufacturing practice manufacturing capping equipment and different capping equipment settings and their impact on product quality and integrity, as determined by residual seal force.The capping plate to plunger distance had a major influence on the obtained residual seal force values of a sealed