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Supply schedule updates from our Health products customer service team
Nuclear Medicine

Delivery schedule

Tc-99m generator supply update

23 January

ANM recommenced production over the weekend; however, an unexpected mechanical issue occurred during the resumption of operations. Although this issue has now been resolved, some deliveries have been delayed further.

Most customers with deliveries re-scheduled for Tuesday, 24 January, will now receive generators on Wednesday, 25 January.  

A small number of customers scheduled to receive their delivery on Tuesday, 24, and Wednesday, 25 January, are expected to receive their delivery on Friday, 27 January, as we continue to clear the backlog of orders.

ANSTO anticipates deliveries will return to normal from Friday, 27 January. 

Impacted customers are being notified directly. Further supply updates will be shared directly with customers and on the ANSTO website as required.

For product enquiries, please contact health@ansto.gov.au.     

 

Previous Tc-99m generator supply updates

20 January 

ANSTO continues to work towards ANM’s resumption to regular production operations over the weekend.  

Consistent with advice shared yesterday, customers due for Tc-99m generator delivery between Friday 20 January and Monday 23 January are expected to experience a delay of between one to two business days.   

It is anticipated that some customers with deliveries scheduled for Wednesday 25 January may also experience a delay of one business day as we clear the backlog of orders.   

Further supply updates will be shared on the ANSTO website by 5pm AEDT on Monday 23 January.

19 January

ANSTO’s Manufacturing Facility, known as ANM, is currently experiencing production delays affecting the short-term supply of Molybdenum-99 (Mo-99).

On Wednesday 18 January during routine product quality inspections, ANSTO detected that the final product was out of specification. Subsequently, the individual batch was rejected, and all impacted Mo-99 was contained and disposed of. 

To ensure the facility continues to meet the stringent product quality specifications and regulatory requirements, ANM immediately took measures to identify the source of the deviation and rectify the situation. As a precaution, it is anticipated it may take several days before production of supply will recommence.

This delay will impact the supply of Tc-99m generators to the majority of customers scheduled to receive generators between Friday 20 January and Monday 23 January. At this stage, we anticipate this will likely delay delivery by one to two business days.  

All other products including Tc-99m generators currently in use, are NOT impacted. Prior production batches of Mo-99 also remain unaffected. 

Next steps: 

All supply assessments are based on current information. ANSTO will aim to provide further supply updates via the ANSTO website by 5pm AEDT Friday 20 January. 

 

Global nuclear medicine supply shortage

7 November 2022

ANSTO's OPAL reactor has successfully restarted. Through the week of 14 November, Tc-99m and I-131 supply will be returning to normal with a low risk of disruption.

  w/c 7 November w/c 14 November
Tc-99m generators

Delays or cancellations due to very low activity.

Supply returning to normal with a low risk of disruption.

I-131 capsules and solution

Limited availability.

No supply of large solutions.

Supply returning to normal with a low risk of disruption.

Lu-177 n.c.a. Supply as normal. 

Supply as normal with a low risk of disruption.

 

Previous global nuclear medicine supply communications

3 November 2022

The latest Lu-177 supply updates for the w/c 7 November and w/c 14 November are available in the table below.

  w/c 31 October w/c 7 November w/c 14 November
Tc-99m generators

Supply as normal.

Delays or cancellations for deliveries on 4 November.

Delays or cancellations due to very low activity.

Supply is anticipated to return to normal with potential disruptions. Customers will be notified of the supply plan on 7 November.

I-131 capsules and solution Supply as normal. 

Limited availability.

No supply of large solutions.

Supply is anticipated to return to normal with potential disruptions. Customers will be notified of the supply plan on 7 November.

Lu-177 n.c.a. Supply as normal.  Supply as normal. 

Low risk of disruption to supply.

1 November 2022

The global shortage of nuclear medicine continues to impact supplies worldwide, including in Australia.

ANSTO has worked with the Nuclear Medicine Working Group to ensure equitable access to the minimal Tc-99m generator activity available for the Australian community for delivery on Friday, 4 November and Monday, 7 November. Customer Service will contact individual customers and notify them of their allocation.

There is an increased risk for Lu-177 supply in the w/c 7 November and w/c 14 November. Customers will be notified if their supply is impacted.

  w/c 31 October w/c 7 November w/c 14 November
Tc-99m generators

Supply as normal.

Delays or cancellations for deliveries on 4 November.

Significant delays or cancellations due to very low activity.

Supply is anticipated to return to normal with potential disruptions. Customers will be notified of the supply plan on 7 November.

I-131 capsules and solution Supply as normal. 

Limited availability.

No supply of large solutions.

Supply is anticipated to return to normal with potential disruptions. Customers will be notified of the supply plan on 7 November.

Lu-177 n.c.a. Supply as normal.  Increased risk of cancellations. 

Increased risk of cancellations.

28 October 2022

ANSTO has assessed the availability of Tc-99m, I-131 and Lu-177 n.c.a.  for customers throughout November. This is based on a predicted global shortage due to a number of reactors being shutdown around the world, including ANSTO’s OPAL reactor.

There will be impacts to supply, and while ANSTO is importing products throughout the OPAL shutdown period to try and minimise customer impact due to the limited global supply, it is anticipated the impacts will be significant for the week commencing Monday 7 November.

ANSTO anticipates a lower yield may be experienced once the OPAL reactor restarts on Friday 4 November.

All supply assessments below are based on current information at hand. 

ANSTO’s Customer Service Team will contact impacted customers, and further updates will be shared as more information becomes available.

For product enquiries, please get in touch with health@ansto.gov.au

Domestic 

 

w/c 31 October 

w/c 7 November 

w/c 14 November 

Tc-99m generators 

Supply as normal. 

 

Delays or cancellations for deliveries on 4 November.* 

Significant delays or cancellations due to very low activity.* 

 

Supply as normal on 11 November. 

Supply as normal 

I-131 capsules and solution 

Supply as normal. 

Limited availability. 

 

No supply of large solutions. 

Supply as normal 

Lu-177 n.c.a. 

Supply as normal 

Likely reduced availability  

Likely reduced availability  

* ANSTO is working with the Nuclear Medicine Working Group to ensure equitable access of the very limited activity for the Australian community 

Export 

 

w/c 31 October 

w/c 7 November 

w/c 14 November 

Tc-99m generators 

Cancelled 

Significant delays or cancellations 

Supply as normal 

I-131 capsules and solution 

Supply as normal 

Cancelled 

Cancelled 

27 October 2022

ANSTO has assessed nuclear medicine availability for customers throughout November based on a predicted shortage due to a number of reactors being shutdown around the world.

We anticipate changes to supply because ANSTO is importing products throughout the OPAL shutdown, and lower yield may be experienced when the OPAL reactor restarts.

All supply assessments are based on current information.  

Tc-99m generator supply updates will be available on the ANSTO website by 1pm AEDT 28 October. ANSTO will provide further updates as more information becomes available.

26 October 2022

  • ANSTO has been made aware that a number of reactors in the global nuclear medicine community are currently in shutdown. 
  • This is expected to impact the global supply of Tc-99m, I-131 capsules and solution and Lu-177 n.c.a throughout November. 
  • This disruption impacts the products ANSTO imports to maintain nuclear medicine supply because the OPAL reactor, one of the three facilities used to produce nuclear medicine, is currently undergoing scheduled maintenance. It is planned that OPAL will restart on 4 November. 
  • ANSTO is informing customers of an increased risk to the supply of Tc-99m generators, I-131 solutions and capsules and Lu-177 n.c.a. during November.   
  • We anticipate disruptions to supply during the weeks of 31 October and 7 November. 
  • At this stage, we are unsure of the customer impact but are working with our suppliers to assess options to ensure we can meet demand. 
  • ANSTO will provide a further update, on Friday 28 October by 1pm AEDT.

21 October 2022

ANSTO is working to minimise customer impact following an unplanned reactor outage experienced by one of our international suppliers.

The outage impacts the products ANSTO imports to maintain nuclear medicine supply while our OPAL reactor, one of the three facilities used to produce nuclear medicine, will undergo scheduled maintenance from 23 October to 4 November.

We've increased output from our Mo-99 Manufacturing Facility, balanced production and product expiry times, and secured Mo-99 from another overseas supplier to deliver nuclear medicine, but we anticipate there may be some supply delays and cancellations.

Based on current information, we believe:

  • On 4 and 7 November, some domestic Tc-99m generator deliveries will be delayed by one business day.
  • ANSTO will contact impacted customers from 24 October.

We anticipate supply will return to normal from 11 November.  

 

Tc-99m glass vials

24 September 2022

The saline vials that ANSTO provides with the Gentech and Technelite generators and evacuated vials provided with Gentech generators have now passed ANSTO’s quality assurance testing.

After consultation with the supplier and the TGA, ANSTO is advising customers that the quarantine notice previously issued on 21 September 2022 is being withdrawn, and hence customers are permitted to resume the normal intended use of these vials.

ANSTO and its supplier’s investigation and risk assessment have determined the product is safe for patient use.

Why is the product being released?

  • Significant testing of the vials to ascertain the likely cause of the residue within the vials has been undertaken. The findings are that the substance identified in the glassware is a silicon compound.  
  • ANSTO has reviewed the possible impact to patient safety, and concluded any residual risk is low.
  • The supplier has advised it is lifting the quarantine of their own stock and will resume normal operations.

When will customers next receive saline vials?

  • Customers who did not receive saline vials last week will receive them on Tuesday 27 September.  
  • Normal vial deliveries will resume from Tuesday 27 September.
Previous Tc-99m glass vials communications

23 September 2022

ANSTO continues to work constructively with the TGA and the supplier. We are working through our analysis and will be able to provide customers with an update on the evening of 24 September.

21 September 2022

ANSTO’s supplier of the glass vials used in several nuclear medicine products has advised us of a quality issue. The quality issue is an unexpected residue of unknown origin found inside the glass vials. The issue is limited to vials only.

Currently, ANSTO is only aware of the issue affecting vials provided as part of our Tc-99m generators.

At this stage, the impact, if any, of the residue on patient safety has not been fully determined.

ANSTO is directing customers to not use the saline vials provided with the Gentech and Technelite  Tc-99m generators and the evacuated Gentech vials until the impacted products have been assessed. The Technelite evacuated vials are not impacted and can be used.  

Impacted vial batch numbers

The left column is ANSTO's batch number. You will see the vendor batch number on your products.

5ml Saline (ANSTO batch number)

Vendor batch

1002970

4164

1003083

4180

10ml saline (ANSTO batch number)

Vendor batch

1002861

4134

1002971

4160

1003023

4169

1003054

4172

1003070

4174

1003086

4179

1003149

4184

30ml Evac (ANSTO batch number)

Vendor batch

1002899

4141

1003009

4157

1003047

4165

1003071

4166

1003093

4182

1003151

4167

This advice is based on ANSTO’s risk assessment and commitment to patient safety and meeting the highest possible quality assurance standards and applies to the above batch numbers.

Next steps 

ANSTO is working cooperatively with the supplier and the TGA and is undertaking analysis to quantify any risk to patient safety so we can advise customers of the action required. This could mean a return to business or recall of the vials depending on the results of the investigation.

ANSTO will provide an update by Friday 23 September.

If you have any questions, regarding exemptions, please contact the TGA via info@health.gov.au.

For product enquiries, get in touch with health@ansto.gov.au.

Delivery and calibration 

I-123 radiochemical  

 Available for delivery and calibration on the following dates:

  • 24 January
  • 7 February
  • 21 February
  • 7 March
  • 21 March
I-123 MIBG

Deliveries will take place on the following Thursdays:

  • 2 February

  • 16 February

  • 2 March

  • 16 March

  • 30 March

We will endeavour to keep all hospitals updated as soon we have any further information. We still face some domestic challenges surrounding flights and will continue to be in contact with you regarding the final delivery time to your hospital.   

The cut-off time remains 5 pm on Wednesday the week prior to the shipment unless otherwise specified.

Get in touch

If you would like to place a product order or have any further questions please contact the Health team.