Drug and primary packaging: an overview of related issues (Darshan Makhey, PDA India Chapter)
The use of prefilled syringes is a modern way to administer parenteral drugs. With the achievements in science and technology in the past twenty years an increasing number of injectables use prefilled syringes.
The benefits compared with vial-disposable syringe concepts are obviously convenience and ease of handling as well as advantages in safety and a reduction of drug overfill.
This presentation covers the basics of Extractables and Leachables with a specific focus on Prefilled Syringes. The Office of Pharmaceutical Sciences view together with US and EU guidance for container closure systems on best practices for accounting for Extractables and Leachables shall be discussed.
A risk based approach to use these agency guidance shall be presented. Common errors in analytical methods and techniques used for characterization of Extractables and Leachables shall be highlighted.
Finally, several case studies related to use of rubber stoppers, tungsten filaments, plungers, glue used for attachment of needle, silicone, glass etc., shall be discussed.
The pharmaceutical market is moving towards complex and specialized drugs where the aim is more effective treatments targeting specific diseases.
This new scenario requires a high degree of flexibility to shorten development cycles and time-to-market, still providing superior quality containers to safely store these high potential drugs.
The simultaneous availability of high speed cameras, high brightness solid state sources, powerful multi-core processors and high throughput interface network is providing new methods for improving detection efficiency and reducing false rejection by collecting and fusing more data on the inspected product.
The growing trend is to choose combined packaging and devices including a set of key features that simplify all the operations in order to allow the Pharmaceutical Companies to focus on drug developments.
This paper presents an integrated solution to meet the market requirements focusing on new process and packaging concept that improve the quality inline and enlarge the range of glass containers ready to be used.
Interaction between rubber closures and sensitive drugs: leachables and extractables (Bram Jongen, Helvoet Pharma)
The 1999 FDA’s Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics introduces the “suitable for its intended use” principle when discussing primary packaging material. One of the aspects to verify is the compatibility or interaction between the drug product and its packaging.
Performing extractables and leachables studies have become a standard to understand this compatibility or interaction of a container closure system.
Rubber, having the most complex composition and hence the most complex extractables profile, is discussed in more detail in this presentation starting with an overview of typical ingredients and additives used in rubber formulations for pharmaceutical use.
A discussion on how to establish an extractables study and subsequent how to set up a leachables study is given.
This presentation describes how a self-injection device is developed from the first idea all the way to a fully industrialized product.
The key criteria for selecting the appropriate primary container and the corresponding device type, the essential parameters for the container–device interface and the main rationale for selecting either a disposable or reusable device are explained.
Advanced label solutions for pre-filled syringes (Rainer Alberth, Schreiner MediPharm)
The presentation provides an overview on state of the art technologies for the labeling of syringes. Customized label solutions with integrated functionalities can add value to the product, considering regulatory as well as marketing aspects.
Labels including documentation segments can for instance play an important role in patient safety. In the field of anti-counterfeiting and track & trace, integrated security features help increase the hurdle for counterfeiters.
As regards the important topic of needlestick injury prevention in healthcare environments, labels with integrated needle protection offer benefits to end users as well as pharma manufacturers, combining safety and cost efficiency.
Besides, barcoding on unit doses is increasingly demanded by the market, and interactive electronic communication with labels will become more important in the future.