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Formulation

Dispense logoOverview
DISPENSE is a comprehensive computer based system for test item control.

The DISPENSE system maintains a full record of test item usage right from the initial receipt through formulation/dispensing activities to disposal.

DISPENSE makes extensive use of bar code identification and on-line electronic data capture from balances to ensure the highest level of data integrity.

Test Item Receipt
On receipt, the test item is logged into the DISPENSE system by completing a series of on-screen forms. Some information is mandatory such as name, batch number and expiry date. When all the details have been registered, each container is then assigned a unique barcode by Dispense and labels produced.

  • All test substance containers carry a unique bar coded label
  • The test substance expiry date prevents it from being used in a formulation after expiry
  • All receipt amendments are audit trailed
  • Gross test substance container weights may be recorded on-line

Formulation Specification
Formulation instructions are entered into DISPENSE on a per study or project basis and each test substance batch is linked to a study or project. The formulation specification includes details of the test substance to be used, concentration, vehicle and formulated volume (or weight). Following completion of a formulation specification, bar coded labels are printed for all formulation containers.
Formulation options include:

  • solutions / suspensions (mg/ml)
  • solutions (%)
  • capsules (mg)
  • dietary formulations (mg/kg)

DISPENSE uses a formulation matrix which covers the requirement for multiple test substances and/or multiple vehicles for some projects.

Formulation Preparation
Formulation activities are controlled by DISPENSE. The bar coded labels on all formulation containers and vehicles are used to verify each step in the formulation process. The information on each formulation container label includes the project number and the dose group.

DISPENSE:

  • calculates the amount of test substance and vehicle required for each formulation
  • ensures that correct weights of test substance and vehicle are used
  • records all weights on-line

After entering a study or project number, you are prompted throughout the preparation process to carry out weighing procedures according to the project formulation details. Balance readings are recorded on-line. Only balances that have previously been identified to the system may be used. Identifying the balance includes specifying the balance serial number, a description of the balance, and the number and values of the check weights to be used before any weighing may be carried out on the balance.

Accountability
DISPENSE requires the formulator to weigh the bulk test substance container before use on each formulation occasion (Start of Day Accountability). The bulk test substance container is then weighed following completion of formulation work (End of Day Accountability). DISPENSE calculates the theoretical usage of test material and compares this to the actual usage to produce an Accountability Report. Any discrepancy has to be accounted for by the formulator entering an appropriate reason into DISPENSE.

Reports
A variety of reports on test substances and projects may be generated. These include Test Substance Receipt, Formulation Specification and Accountability reports. Both standard and custom reports can be produced.

Security
Access to all areas of DISPENSE is controlled by a user ID password. Each user is assigned an ID and set of access privileges to the application. This means, for example, access to enter formulation specification details can be assigned to some users and not others.