Achieving Sterility in Ready-to-use Pharmaceutical Packaging

 

Injectable drugs bypass our natural barriers to infection, such as our skin. Therefore, pharmaceutical companies must ensure a strictly controlled and regulated level of sterility for their products. To reach this mandatory level, different technologies are applied depending on the properties of the product.

Sterilization techniques are divided into two broad but differentiated fields: physical and chemical, depending on the nature of the sterilizing agent. The individual technologies may be familiar, but they have advantages and disadvantages that make them more or less suitable for use in specific applications in the pharmaceutical industry.

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The Family of Sterilization Technique

From an environmental and safety point of view, steam sterilization has many advantages: it produces tap water as waste and is relatively easy to handle compared to some of the chemical technologies. It is considered state-of-the-art technology for some applications, including ready-to-use cartridges.

However, for some primary and secondary packaging, for example, glass and polymeric syringes, heat poses a risk to some components, such as plastic parts or needle adhesive, which may affect stability. Mechanical and dimensional or to the force of extraction of the needle. Therefore, the suitability of steam sterilization for the items to be sterilized, e.g., syringes, should be verified on a case-by-case basis.

Radiation Sterilization

Ionizing and non-ionizing radiation are the other primary physical means for sterilization. Non-ionizing ultraviolet light has a very short wavelength, and its high energy destroys colony-forming units (CFU) by breaking chemical bonds. But while UV light sources are plentiful and the technology is quick to use, UV light provides little penetration or none at all. Therefore, it is primarily used for surface decontamination, especially before introducing into an aseptic isolator.

Its low penetration also makes it prone to shadowing, which means it is ineffective if surfaces are not directly exposed. Therefore, more complex mechanics are required to ensure that the entire surface of the object has been exposed to a sufficiently high dose. The materials may deteriorate depending on the materials used and the dose to which they are exposed.

 

Ionizing and Non-ionizing Types of Radiation Sterilization

Ionizing types of radiation are used more frequently than non-ionizing ones. Gamma radiation offers high penetration, its cost is attractive, and it does not leave residues that could cause harmful side effects. However, it works against it by turning clear borosilicate glass brown; a phenomenon called solarization, which makes post-fill optical inspection and particle detection in the finished product difficult. However, it can be used for polymeric containers, where solarization is not so pronounced.

Electron irradiation is the most widely used technique in the fill and finish industry. Its penetration is less than that of gamma radiation but more significant than that of ultraviolet light and leaves no residue. Due to its medium penetration, it is mainly used for low-density products. As with gamma radiation, it causes borosilicate glass to solarize, and at high doses, it embrittles the polymers of the secondary packaging. A significant advantage of the electron beam is that the radiation output can be turned on and off as needed, unlike gamma radiation. This dramatically improves radiation safety when handling these devices.

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