Evaluate your learning experience within the group.

• Individual Learning log &Meeting Minutes- 5%

Assignment Scenario

Process Overview

Weekly orders from the distributor come in as 100,000 units (each unit equates to 1 injectable device). Your process allows you to yield approx. 9850 Litres/per formulation tank. Each formulation tank is 10,000L/batch size. Therefore there is a 98.5% yield/batch due to the fact that material is lost priming lines to reach the fill lines, fill set-up and sampling). See detail attached for changeover time over the last 30 days.

3. Sodium citrate 100Kg

4. Sodium dihydrogen phosphate dehydrate 300Kg (added together (but first in the order) with item 5 at once)

9. Active Protein 400g

10. Water for injections 10,000L

Mixing and formulation of the excipients takes approximately a second 8 hour shift (sometimes it goes over the 8 hour shift). 6,000L of water is added to the tank (approx. 1hour to do fill). Then the components are added in the above order of addition. Each component must be mixed for 15-60 minutes (Mixing is usually done for the minimum 15 minutes, however sometimes it goes over this time). Once all chemicals are added water is added to bring up to 10,000L mark. Samples are removed for in-process testing. Testing is a separate operation and takes 1 shift to complete and review of the test documentation. The product is sterile filtered en-route prior to filling. On average they spend 45 minutes doing set up for every process order (i.e. the mixing and formulation element of the process), each time the tank is mixing the operator is waiting. It takes two operators to complete each process order.

Product should ideally be filled from the 10K tank within three shifts (1 day) of completing the formulation. The filling process itself takes 1.5 shifts and a half shift for set up of filler and equipment (you can hold material in the tank for up to 3 days ). Approx. 98,500 pre-filled (100ml) syringes/Units are yielded from each tank. Usually they are packaged as 1 syringe in box for the customer. Three operators are required to complete each process order.

Fill Change over times

Average no of Process Orders Waiting at each Stage over a 4 week timeframe

Bulk Formulation-15%

Fill- 10%

-Any information sourced must be referenced using the Harvard Referencing System.

Template 1 (Compulsory). Group Action Plan

Template 2: (Optional) Individual learning log (Completed by individual after the Project)

Evaluate your learning experience within the group.

Reflect on the sections below. This will help you develop your learning strategies and improve your contribution to the group process.