We live in times of challenging health issues, as well as times of miraculous medical achievements and technological advances.
We have seen a viral pandemic overtake the globe in a few months, but we have also seen the development, testing, and distribution of a vaccine in just about a year’s time. The key component of delivering new drugs to the market is the design and use of safe, high quality, and effective packaging. This packaging must protect the drug product from environmental influences that may affect the safety or effectiveness of the drug product. Bacterial and viral contamination are obvious safety issues for parenteral and other drugs, but heat, light, oxygen, and CO2 are other environmental influences that can impact the effectiveness of new drugs. Adding to the challenges of packaging are the more stringent demands on packaging that may be required for new, large protein vaccines and therapeutics, such as the mRNA vaccines for COVID 19.
The ubiquitous, rubber stoppered glass vial will likely continue to be a workhorse for the parenteral drug industry for years to come. However, new drug packages, for parenteral and other drugs, are being designed and brought to the market with increasing frequency. The single use, pre-filled injectable drug package is a marvel of design and engineering, and promises to bring safe, easy, and effective drug delivery to people worldwide. Blister packages are gaining in popularity as effective, safe, and inexpensive packages for drugs in the form of pills and tablets. Other drug packages are sure to be designed and implemented for new classes of drug products and medical devices.
But, no matter how exciting or novel a new package design may be, it must be proven to provide effective containment of the drug product, such that the drug product is protected from the environment, during packaging, storage, transportation-all the way to delivery to the people throughout the world. Package validation and Container Closure Integrity Testing (CCIT) are the tools used by drug manufacturers to ensure that package systems meet the requirements necessary for safe delivery of drug products to the point of use. The requirements for Package Validation and CCIT are becoming more rigorous, as new and more valuable drug product are being developed and introduced every day. From deterministic test methods/equipment, to positive controls with laser drilled holes at 5um and below, Package Validation and CCIT are entering a new era of importance and repeatability.
Oxford Lasers provides a laser drilling service to produce positive controls/calibrated leaks in primary pharmaceutical packaging. Visit our application page or contact us for more information.