vygon (uk) ltd - customer care (01793) 748800
Quality & Innovation in Healthcare
 

Accufuser Elastomeric: New drug stability data now available for 24hr administration of piperacillin 

Posted by Vygon UK  on 27-March-2018 
Accufuser Elastomeric: New drug stability data now available for 24hr administration of piperacillin

In order to assign a shelf life to a prepared product in an elastomeric device, comprehensive stability tests must be completed.

NHS standards, known as the Yellow Covered Document (YCD) stipulate the minimum testing requirements before an expiry date can be given.

These include:

  • Testing temperature requirements: 32°C +/- 1°C for in-use ‘near to body studies’ (for elastomeric devices and similarly insulated devices)
  • A concentration of 95-105% of active pharmaceutical ingredient must be present at the end of infusion
  • All samples tested in duplication
  • Low and high ‘clinically significant’ concentrations
  • Complete physical stability testing e.g. colour, clarity, precipitation, pH
  • Three samples at each time point
  • At least four time points plus time zero
  • Use of a stability indicating assay e.g. HPLC.

 

We can now confirm that the YCD drug stability data specifically for piperacillin and tazobactam is now available.

 

To request the full stability protocol simply click the link and fill in your details: 

 

Request Protocol

For more information please use the Contact Form