5 Myths - Sterility of Biopharmaceutical Consumables

28.05.2019
technology sterile gamma irradiation
28.05.2019
technology sterile gamma irradiation
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There is a lot of confusion in the biopharma market about gamma irradiation and sterilization. Here are 5 common myths debunked that will provide some guidance.

1) When an item is exposed to gamma irradiation, it can be considered validated sterile.

MYTH! Merely exposing an item to gamma irradiation does not mean the item is validated sterile. The item must be part of a sterility validation program which is a comprehensive testing program that combines a validation rationale, testing results, dose certificates and a set frequency of dose audits.

2) Supplying an item validated sterile should cost the same as a gamma-irradiated item.

MYTH! Because of all the extra items needed for testing along with all the testing itself, there is a significant cost to the supplier to pursue the validated sterile claim. There is also an additional risk for the supplier to make this claim which also adds to the cost of the item.

3) Every new item configuration can be considered validated sterile if the supplier has a sterility program in place.

MYTH! Only if the supplier has every component tested (or product family, see below) and verified under their sterility program. If a customer requests a component on a system that hasn't been put through the sterility program, it will have to go through the comprehensive testing program, unless rationale can be provided that the component falls in the same product family of a comparable existing component. This rationale is determined by the supplier.

4) Sterilization dose audits only need to be performed once.

MYTH! The frequency of these audits is based upon previous successful results as well as the production schedule, which should be at least once a year. If there is no regular production dose -  audits may need to be performed on a per lot/batch basis.

5) Large Single-Use Systems (SUS) cannot be validated sterile.

MYTH! Large assemblies do present a challenge when evaluating for sterility. However, there is an option to cut the assembly into smaller proportional/representative sized pieces called sample item portions (SIPs). These can be tested on their own to have bioburden and sterility resulted combined to establish the dose required for the complete system.

Sterility Assurance programs and the details can be quite confusing and intimidating, and these were only a handful of the myths that are circulating around the market. The good news is that more resources are becoming available as well as more suppliers are getting sterility assurance programs set up. As a consumer, evaluate if the part needs to be validated sterile for its application and confirm with the supplier how the part is sold.  When purchasing validated sterile parts ask for information about the product sterility program and revalidation schedule. There may be multiple options available for sterility at different price points, based on the end user needs, so be sure to discuss these with the suppliers.

By Kelly Jakinovich