Understanding Terminal Sterilization
Keeping things clean, safe, and sterile is one of the most crucial parts of healthcare protocol. But, more often than not, when the term “sterilization” is mentioned, most are unsure of what the exact process is. We’ve outlined what sterilization is, and how MediZap utilizes it in our processes and protocols to ensure your compounds are as safe as possible.
A Primer On Sterilization
Sterilization is a process designed to destroy and remove all forms of life present in a defined area. It’s accomplished by the use of either physical or chemical means. It can also be used to eliminate quasi-living biological agents, such as viruses and prion (proteins dangerous to humans).
Failure to remove viruses and prions from drugs can present serious ramifications for patient and personnel safety, so it’s important to select the most-appropriate sterilization technique. Terminal sterilization is the method of choice for products that are sufficiently stable and are ready for a final sterilization in final packaging. It’s considered by ISO (International Organization for Standardization (ISO)) as the optimal means of sterilization per their standards.
Terminal sterilization is most commonly accomplished by moist heat, and a very limited number of drugs are treated with dry heat after filling. There is growing interest in the use of radiation, including low-energy E-beam as a terminal treatment, suggesting more products will be processed in this manner.
How MediZap Performs Sterilization
MediZap's electron-beam processing, or electron irradiation, is the most advanced sterilization technology on the market. This technique uses beta radiation - a form of high energy electrons - to penetrate and disrupt microorganism’s RNA/DNA chains (their genetic material and means of survival). Electron beam provides the highest level of sterility assurance at 10⁻⁶. When these chains are disrupted, it means that the microorganism can no longer survive, and eliminates any risk of their contamination.
Compared to gamma sterilization where the rays occasionally collide with an electron and give it enough energy to destroy bio-burden, our technology initially starts out at high energy and destroys bioburden directly by having both a high dose rate and lower penetration. With a higher dose rate, the electrons generated by the accelerator operate in a continuous-beam mode to irradiate your product in minutes, significantly reducing the risk of degradation of your products. This is critical when working with compounds that may already have some degradation due to the way that they were created, meaning that your products will stay as stable as possible when sterilized through our methods.
The MediZap Difference
By using established and recognized dosimetric release procedures, lot based sterility testing is not required after processing, fast-tracking your turnaround time from Gamma's standard 5 - 8 business days to only 2 business days with Medizap.
While sterilization itself does not require downstream validation for use in a manufacturing setting, it is highly recommended that this process be closely monitored and quantified wherever possible to ensure safe, reliable results that increase both patient and personnel safety.
We’re proud of our unique, effective, and industry-leading sterilization protocols! Contact us today to learn more about our methods and how we can work together.