Sterilization is an integral part of the pharmaceutical production process. Containers that are intended for sterilization in the pharmaceutical industry are processed according to the kind of medicine that is to be stored in them. Even containers that come from other suppliers can be contaminated by a variety of elements and microbial life. It is essential to clean and sterilize each container before filling it. The most popular way to achieve this in the industry is by using a container decontamination system. This is especially true for injectable drugs, which need to satisfy several requirements before they can be supplied. Let’s take a look at the process used for this.
Washing is an essential step in cleaning the glass containers as it removes all abiotic contaminants and a few of the biotic ones. Most glass containers can contain tiny particles of glass, rubber, metal, or even some alkaline oxides. All of these can be removed by utilizing a machine to wash out the containers. The machine first uses an ultrasonic chamber to remove the “available” from the containers, leaving the “not available” ones for the next step. These are then removed by water washing and then blowing sterile air into them.
This approach can have over 600 different washing cycles, and each of them is designed to meet each drug’s specific decontamination requirements. The washing machines utilized for this process need to have a discharge system that releases containers from the basket while maintaining sterility.
The next step in the case of most glass containers is heating them to high temperatures. The containers are inserted into dry heat sterilizers that heat them to temperatures between 160°C and 500°C. This process can kill a majority of microbes without causing any significant damage to the container. Good quality machines include systems to invert and ventilate the containers with sterile air to prevent the glass’s cracking. Repeating this process several times is not advised as it can flake the class and create chances of internal contamination after the container has been filled.
Irradiation is also a plausible method for sterilization of glass containers meant for injectable medicines. In this case, however, it can change the glass’s color and render it unacceptable for most purposes. For this purpose, it is advisable to use specialized pharmaceutical glass, which wouldn’t change color when under the impact of ionizing radiation.
The final step in the process involves chemical sterilization. This can be avoided if the glass has been irradiated but is advisable in all other cases. Most machines would use Ethylene Oxide, Hydrogen Peroxide, or Ozone for such sterilization. This method is especially beneficial for containers that cannot be sterilized with the steps mentioned above. The step helps remove all remaining contaminants altogether.
It’s easy to see that the pharmaceutical sterilization process is serious business. Facilities must employ sterilization methods compatible with the containers and drugs in question. After the process is completed, the containers can be filled and shipped for market use.