, Inc. recently announced the discontinuance of the Unispore®
Biological Indicators (BI) Catalog No. 61301600397 and 61301600398, and the associated Culture Media Tubes No. 61301600418 and 61301668674.
Customers that use the Unispore® BIs for sterilization monitoring will be impacted by this change. Please consider the following when assessing an alternate BI:
- Use an alternate BI manufactured by a different company. ANSI/AAMI/ISO 14161:2009 states that different BIs can provide varying degrees of challenge to the sterilization process. A correlation between the different BIs used for cycle development and validation should be established and documented through performance qualification and routine monitoring. Performing a half cycle with the newly established BI and performing a routine cycle with the new BI alongside the Getinge BI may satisfy this requirement.
- The main advantage of the Getinge Unispore® BIs is they incubate for a minimum of 5 days. This is crucial for some customers as the overall production time is shortened. Since no other brand offers this benefit, the FDA has published a protocol for the validation of BI incubation times. The testing performed under this protocol determines the minimum incubation time, which in many cases is less than the 7 days required by ISO standards. Nelson Laboratories, Inc. offers this testing, if you require shorter incubation times.
- Any other alternatives taken by the customer should be evaluated for risk at each level of production and proper documentation should be maintained.
Other considerations in the selection of a different manufacturer include the establishment of a high level of confidence in the supplier, including the possible testing of the BI to cover the performance characteristics of the BIs prepared. When possible, the user should purchase BIs manufactured according to the specifications given in the ISO 11138 series, pharmacopoeia monographs, or other applicable standards.
Should you need assistance with this transition; Nelson Laboratories, Inc. sterilization experts can explain the options and testing available to you. We are here to guide you through the process.
Additionally, Nelson Laboratories, Inc. has a limited stock of Getinge BIs available for sale to our Process Challenge Device (PCD) customers. Please contact your Nelson account manager if you need to place an order. Culture media is also available for BI testing for a limited time until the media is depleted.