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TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 137

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 137

Products affected: See Appendix 1, below

See attached.

It is our intention to change the Manufacturing Process of the products listed below. The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Proposed Change Date: 14-04-2025

Change Details:

Change to bag design on the above product codes, these products are supplied in 2,4,7 and 10L bags.

The change is required due to the incumbent supplier restricting availability on these bag lines.

We have taken the opportunity to develop the bag design to incorporate some customer design requests.

Reason for Change:

The incumbent supplier has restricted supply on one bag line and has indicated further restrictions will apply to the remainder of the product range, forcing TCS to find a long term supply option.

Considerations:

Extensive trials were held in house to ensure the bag quality, supply chain and end product quality were not affected by the proposed change. There is no significant difference in the connections available to the user, these have been kept consistent with the current supply.

Conclusion

The bags and their design have passed the TCS product trial criteria and incorporates customer design change requests. The change ensures long term stability of supply to both TCS and our customers.

Appendix 1

Product codes Volume
DEFIBRINATED HORSE BLOOD
HB001B 1LTR
HB001L BULK
HB003B 1.1 LTR
HB079B 1.5LTR
HB002B 2LTR
HBO68B 2.7LTR
HB058B 3LTR
HB099B 3.5LTR
HB014B 4 LTR
HB004B 5LTR
HB011B 5.5LTR
HB009B 6LTR
HB007B 7 LTR
HB005B 7.8LTR
HB008B 8LTR
HB071B 10LTR
 
LYSED HORSE BLOOD
HB069B 2.6LTR
HB070B 5LTR
 
DEFIBRINATED SHEEP BLOOD
SB006L BULK
SB006L BULK
SB001B 1LTR
SB009B 1.5LTR
SB003B 2LTR
SB113B 3LTR
SB1012B 3.1LTR
SB014L BULK QA
SB116B 9LTR
SB095B 10LTR
SB005B 5LTR
SB002B 7LTR
SB210B 10LTR PCV
SB094B 800ML
 
WASHED SHEEP ERYTHROCYTES
SB114B 2LTR
SB115 2.6LTR

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Jan 2025

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