Skip to content

Evaluation of microbiological shelf-life of preparations of cytotoxic agents in infusion bags combined with medical devices

Pdf

PDF Icon

European Statement

Production and Compounding

Author(s)

Timea Botházi, Lone Madsen

Why was it done?

The purpose was to find data for an increased microbiological shelf-life of preparations of cytotoxic agents in infusion bags combined with medical devices. The aim was to increase microbiological shelf-life from 24 hours to 7 days. Existing data were studied to find evidence to support the prolonged shelf-life.

What was done?

The purpose was to find data for an increased microbiological shelf life of preparations of cytotoxic agents in infusion bags combined with medical devices. The aim was to increase microbiological shelf life from 24 hours to 7 days. Existing data was studied to find evidence to support the prolonged shelf life.

How was it done?

A team from the production and quality assurance departments worked together on writing a report that could provide the rationale for the change of shelf-life.
We collected data from
– supplier qualification of the medical devices
– aseptic process simulations (APS)
– process validations
Data were evaluated and risk assessment was performed.
Six medical devices were included.
All suppliers were qualified as low risk.
APS for the specific production process showed no growth.
Process validation data for two types of medical devices showed no concern regarding sterility of preparations.

What has been achieved?

The increase of shelf life was accepted. First product was Blincyto® in infusion bag with Take Set Swan-Lock ® with shelf life increased to 4 days. Patients now visit the oncology clinic only twice a week instead of daily thus saving time and transportation.

What next?

The result means that new product implementation is quick because the only things to evaluate are the stability of the substance and the compatibility of this with materials in contact with it.

×

EAHP Forum

All the EAHP team is working on providing a Forum that can help connect all the members in Conversations and Groups to talk about important matters for the European Hospital Pharmacist.

The Forum will be accessible for all the EAHP members, you don’t have to create a new account to browse and participate.

Conversations and groups

The Conversations will be moderated by our team to provide documents and relevant topics for the community.

The Groups will connect all members that share a category. Members who work on the same assocation, on the same hospital, that have the same role, etc.

Stay tuned for the realase of the forum. Soon on EAHP.