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

Delivery schedule

Scheduled maintenance, Lu-177 and Tc-99m vials

6 October

Nuclear Medicine Processing and Distribution Facility scheduled maintenance
Following scheduled maintenance, production in ANSTO’s Nuclear Medicine Processing and Distribution Facility (B23) will resume on time and as planned from Monday, 10 October.

Planned maintenance takes place to ensure ANSTO can deliver a safe and reliable supply of nuclear medicine to Australians.  

Lu-177 n.c.a. supply
ANSTO produced Lu-177 n.c.a. will be available from Tuesday, 11 October. ANSTO is also working with our external international supplier to accommodate the increased demand due to the backlog of orders from the last two weeks.

Tc-99m vial quality
ANSTO continues to prioritise our work with the supplier to identify the source of silicon residue in Tc-99m glass vials and mitigating strategies.

Our advice issued on 24 September is still current in that the silicon residue poses a low risk to patient safety.

Lu-177 n.c.a. supply

30 September

ANSTO is currently engaging our external international supplier for the short-term provision of Lutetium-177 non carrier added (Lu-177 n.c.a) while ANSTO’s nuclear medicines production facility is undergoing scheduled building maintenance.

ANSTO was informed by this supplier of an unexpected production issue, which has impacted their capacity to supply Lu-177 n.c.a. under this arrangement.  As a result, Lu-177 n.c.a. expected for calibration on Wednesday 5 October 2022 will not be available.

ANSTO will resume domestic production of Lu-177 n.c.a. from Friday 7 October 2022, for distribution to customers the following Tuesday 11 October 2022. 

To accommodate for heightened demand of Lu-177 n.c.a. due to the backlog in deliveries, some orders for the week commencing Monday 10 October 2022 will be sourced from this external supplier to complement ANSTO’s own supply. 

The order cut-off for the week commencing Monday 10 October was 1pm on Thursday 29 September, however, where possible ANSTO will endeavour to accept amendments and additional orders.  

Customers are encouraged to contact ANSTO’s customer service on health@ansto.gov.au at their earliest convenience to discuss their options.

ANSTO understands and appreciates the flow-on impact for patients, particularly the disruptions to scheduled treatments, and we are working directly with our customers as an utmost priority.

Next steps: 

ANSTO will continue to inform customers of any further updates over the course of the next week (commencing Tuesday 4 October) in preparation of a return to business-as-usual operations. 

For product enquiries, please contact ANSTO’s customer service at health@ansto.gov.au

 

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.

Scheduled maintenance

Supply updates and details of the upcoming scheduled maintenance shutdown of ANSTO's Nuclear Medicine Processing and Distribution Facility can be found below. 

Product Timing Update
Technetium-99 Gentech® Generators

5 September -

7 October

Alternate supply is secured
5 generator sizes will be available (5Ci, 7.5Ci, 10Ci, 12.5Ci & 15Ci)
Deliveries are planned to take place on Tuesdays and Fridays (dependent on logistics partners)
Sodium Iodide I-131 capsules and solution

19 September -

7 October

Order cut-off for small and large capsules calibrated on 26 September is 3pm AEDT 15 September 2022
Order cut-off for large solution calibrated for 19 September is 3pm AEDT 15 September 
Orders after 15 September will receive premade capsules limited to set sizes (sizes to be advised)
A limited number of set sizes will be available between 26 September and 5 October
Usual order cut off times will resume from 1pm AEDT 6 October the day prior to delivery
The first available delivery day after scheduled maintenance will be 7 October, calibrated for 10 October
Iodine-131 unstabilised solution

19 September -

10 October

Not available from 19 September until the week commencing 10 October
Sodium  Iodide-123 solution

19 September -

5 October

Orders need to be placed by 1pm AEDT Thursday the week prior to delivery 

The last available delivery day is 13 September
The first delivery day after resuming operations will be 5 October for a Wednesday calibration

The following products are not expected to be impacted:

  • MIBGen® Iobenguane  - 123I Injection Diagnostic*
  • Iodine-131 mIBG Therapy*
  • Chromium - 51
  • Lutetium-177 non-carrier added (order cut-off is Thursday 1pm two weeks prior to delivery)

*Based on current flight schedules and delivery locations

Delivery and calibration 

I-123 radiochemical  

 Available for delivery and calibration on the following Tuesdays:

  • 18 October
  • 1 November
  • 15 November
  • 29 November
  • 13 December
I-123 MIBG

Deliveries will take place on the following Thursdays: 

  • 13 October

  • 27 October

  • 10 November

  • 24 November

  • 8 December

  • 15 December

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.