CIVAS & Cytotoxic medicines production module

Aseptic productionThe module provides stock control for CIVAS and chemotherapy raw materials and finished products as well as extensive support for the production process and entries into a patient’s dispensing history. The module allows for local control with respect to definition of raw materials, finished products and outputs.

Raw materials are selected from the existing product catalogue. The definition of a finished product is fully flexible and functionality is provided to allow the system to calculate a formula for the worksheet or be defined locally. Labels and Worksheets may be tailored on an individual basis such that no two products have the same worksheet/label if desired.

Consumables can be defined within the finished product and these are incorporated into the finished product cost along with any production overhead costs.

Before any item can be prepared, the item must be validated by an authorised user. Each item will have a defined validity period after which the item cannot be prepared without revalidation. Items will also become invalid should a user modify the formula, worksheet or label.

A key feature of the module is the ability to prepare a number of doses of a product with the same concentration for multiple patients in a single isolator session. This process allows for the most economical and practical use of raw materials, as well as the generation of individual batches for each patient with accompanying worksheets and labels.

Using a simple example, three different doses of Methotrexate 25mg/ml for three different patients can be brought together for production in a single transaction. Each dose is individually computed and is added to a list where they can be grouped together depending on local production preferences.

The production process will calculate the amount of raw materials required and allow the user the option to modify the number and size of vials to be issued. Excess quantities from a raw material may be spread across the cost of the prepared doses or issued to a wastage cost centre. The raw materials are issued, the finished product is created and dispensed, the patient history and cost centres updated, and all worksheets and labels produced in a single transaction.

An optional post production process is provided allowing retrospective entry of batch numbers, expiry dates and manufacturer details for raw materials and consumables.

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