When manufacturing in an aseptic environment, it is critical to ensure that the various cleanroom consumables, such as wipers, gloves, swabs, tubing, etc., will not compromise your environment or products with their presence or use. This is particularly important if the final product’s sterility is dependent upon aseptic processing, rather than sterilizing the finished product. In an aseptic environment, entry of a contaminated consumable product could cause your manufacturing process to fail. It is important to understand the sterilization methods used by your consumables suppliers and to ensure that their processes have been validated. There are various methods available to render a product sterile, with autoclaving, e-beam, and gamma radiation being commonly used in the industry. Each sterilization method has advantages and disadvantages that make it suitable for certain applications and unsuitable for others.
1. Steam autoclave uses steam and pressure to sterilize a product. Many products will have to be repackaged prior to autoclaving, as the packaging used during sterilization must be permeable, creating additional time and expense for the process and product. However, autoclaves are available at reasonable prices so it can be an appropriate option for sterilization within one’s own facility, especially when sterilizing small batches.
2. Electron beam sterilization (e-beam) has a relatively low penetrating power, limiting its utilization to low-density products.
3. Gamma radiation has a higher level of penetration and is a preferred method for high-density products and/or large batches. It effectively kills microorganisms throughout the product and its packaging, with little temperature variation. Gamma rays are generated from Cobalt-60 sources and are particularly good at ionization. Because there is minimal variation from batch to batch, gamma radiation is a reliable sterility process. Gamma rays are generated from Cobalt-60 sources.
IRRADIATION ALONE IS NOT ENOUGH
The words “irradiated” and “sterilized” cannot be used interchangeably. Irradiation alone is not recognized by the Food & Drug Administration, or by many pharmaceutical companies, as proof of sterilization. Irradiation simply means that the product was exposed to gamma rays. It does not provide any validation that the product received a sufficient dose to achieve sterility, and a Sterility Assurance Level (SAL) cannot be calculated.
ANSI/AAMI/ISO has established global standards that can be used to validate a sterilization process, providing the necessary documentation to substantiate your methodologies and processes.
The validation process must consider the product’s raw materials and components, the microbial barrier properties of the packaging, and environmental controls in place for the manufacturing, assembling, and packaging of those products.[
CONTACT US if you’d like to find out more information on how CES irradiate and validate our products.