Conventional aseptic filling of drug product into vials ultimately includes a step that requires
time and travel from the stoppering stage to the capping/crimping stage. Lyophilized product …

A new pharmaceutical aseptic vial filling system has been developed based on isolator
technology that is also well suited to use in conventional clean rooms. The results of …

Vial closure systems for sterile parenteral products must provide adequate protection
against external contamination during the lifetime of products on the market. Two …

To demonstrate maintenance of parenteral product sterility, container-closure integrity over
the shelf life of the product is critical. In the past, sterility testing has been used to ensure …

The sensitivity, reliability, reproducibility and ease of use of the WILCO LFC package
integrity test method was evaluated by preparing and testing a series of rubber-stoppered …

Parenteral drug products are protected by appropriate primary packaging to protect against
environmental factors, including potential microbial contamination during shelf life duration …

Closures that form part of the container-closure system are an important component in the
packaging of sterile products. Container-closures maintain the sterility of parenteral …

This presentation describes technical subtleties and complexities associated with validating
the sterilization of closure systems. Also presented are areas of misunderstanding and …

The authors compare four well-established aseptic filling technologies, open vial, ampul,
blow-fill-seal (BFS) and prefilled syringes, to the recently developed closed-vial technology …

The contamination potential of sterile disposable plastic syringes was evaluated after
subjecting the syringes to both simulated in-use conditions and an intentional microbial …