Regulatory action – Isologic Innovative Radiopharmaceuticals Ltd.

Under the Nuclear Safety and Control Act and associated regulations, various levels of regulatory action can be taken by the Canadian Nuclear Safety Commission (CNSC) to protect the health, safety and security of Canadians and the environment.

2018

December 19, 2018

Order to Isologic Innovative Radiopharmaceuticals Ltd.

Today, the Canadian Nuclear Safety Commission (CNSC) announced that it issued a designated officer order on December 19, 2018 to Isologic Innovative Radiopharmaceuticals Ltd., a company based in Dorval, Quebec. The company currently holds a CNSC licence authorizing the possession, transfer, import, export, use and storage of nuclear substances and prescribed equipment for the purpose of processing unsealed radioactive sources into radiopharmaceutical products.

The basis for the order includes:

  • the event that occurred on November 6, 2018 at the company’s Burlington facility, which led to contamination of iodine-131 (I-131) on a worker’s skin and resulted in overexposure to the worker
  • the CNSC inspection conducted on November 16, 2018 at the Burlington facility, which identified deficiencies in the company’s radiation protection program and non-compliances with regulatory requirements
  • the event reported on December 11, 2018 that involved an I-131 release in exceedance of regulatory limits 

In general, the order requires Isologic Innovative Radiopharmaceuticals Ltd. to immediately cease all processing of I-131 at its Burlington facility until actions are taken to train staff, to conduct a root-cause analysis on the I-131 release, and to establish a program to monitor workers’ adherence to procedures. In addition, the order requires the company to immediately make provisions to ensure an adequate supply of I-131 radiopharmaceutical products to Canadian patients throughout the time period of ceased processing.

The CNSC requires these measures in order to protect the health and safety of workers, the public and the environment.

Read the order to Isologic Innovative Radiopharmaceuticals Ltd. (PDF 3,124 kb)

2017

May 4, 2017

Order to Isologic Innovative Radiopharmaceuticals Ltd.

On June 28, 2016, the CNSC notified Isologic Innovative Radiopharmaceuticals Ltd. that it would no longer be authorized to conduct servicing activities on Class II prescribed equipment as of July 1, 2016.

The CNSC had sent multiple notifications reminding the licensee of the imminent expiry of servicing licence 15012-3-16.1 for their cyclotron facilities.

Isologic Innovative Radiopharmaceuticals Ltd. was made aware on multiple occasions of the four-week licence application processing time. An application to renew their licence was submitted on the date of expiry of the previous licence. Servicing activities remained prohibited pending review of the application and issuance of a new licence.

During the assessment of the application, a request for information was sent to the applicant (July 20, 2016) with regard to servicing activities for their cyclotron facilities. On August 18, 2016, the applicant indicated that all servicing was conducted by a licenced third-party service provider.

The CNSC visited Isologic’s Lachine, Quebec site on August 24, 2016, where inspectors discovered that Isologic staff had in fact participated in servicing activities that they were no longer authorized to perform during the licence renewal period, contrary to the information submitted by the applicant. Consequently, Isologic was immediately issued an order to cease and desist from all such servicing activities.

The licensee immediately complied with the order, and promptly submitted an addendum to their service licence renewal application which provided an acceptable basis for renewal of the licence. A new Class II prescribed equipment servicing licence was issued on August 29, 2016, and the order was closed.

Read the order (PDF)

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