sterilization and sanitization.
The final sterilisation of pharmaceutical products or key ingredients using Gamma ray technology is still not used very much despite this being a technology which has been on the market for a number of years. In so many cases, gamma sterilisation is not taken into consideration and production in most pharmaceutical companies is done under sterilised conditions. That said, the irradiation offers numerous advantages even on pharmaceutical products:
- To date, it is the most effective way of eliminating any kind of bacteria.
- It can be applied to small products with special handling conditions.
- It follows industrial ISO with documented methods which confirm and accept the criteria for determining the dosage needed to achieve the required SAL.
- It avoids operating in clean rooms involving, among other things, a considerable reduction in costs, time, endorsements and equipment maintenance for sterile production, thus completely avoiding sterile production.
- Irradiation does not add either humidity or heat to the product, elements which can influence its stability. In addition, the Gammas do not leave residues, resulting in them being fundamental in those cases where the products cannot be effectively filtered.
- In recent years, there has been an increase in research and publications to establish the dosage required to achieve sterility with smaller dosages in order to reduce post-treatment deterioration. These are both ISO approved methods and widely accepted empirical methods.
- The experience in the industry, supported by long-standing, continuous research, confirms the advantages of end sterilisation of APIs via Gamma rays.
At Gammatom, we are specialised in the exact administration of the dosage, ensuring there is no excessive absorption of the dosage, nor in the distribution of low dosages and the application of treatments with greatly reduced uniformity ratios (that is, the difference between the minimum and maximum dosage absorbed by the product). All this is possible thanks to the distinctive features of our plants, designed by Italian engineers at the end of the 1960s and continually updated and improved over the next fifty years of our activities.
In particular, Gammatom has a conveyor plant that works in batch mode and is used for medium/high dosage treatments, as well as a second production line conveyor plant, with a low source activity and, thanks to which, it is possible to administer extremely low, precise dosages, even lower than 0.5 kGy.
The gamma rays can generate deterioration on products like a change in viscosity, colour pH or variations in their molecule stability. Depending on the kind of product, these defects can be eliminated or reduced by intervening physically/chemically on the product prior to irradiation.
Gammatom offers to follow the client at each stage of the approach to sterilisation using gamma rays for finished pharmaceutical products, active ingredients and exipients. Starting with their thirty years of experience with similar products, going from precautionary samplings to tests required to allow the client to ensure the stability of the products and lastly, by providing the client with support when selecting and implementing the endorsement procedure.