Operate the compression suite under supervision

You are a trainee Pharmaceutical Production Operator at Western Sydney.

Simulated workplaceIntermediate missionCAQA Orchard Lane Foods

What is going on

The next ibuprofen 200 milligram tablet batch is scheduled for compression on Thursday and you are working alongside Cass Whitmore, an experienced operator, who will sign off the steps you complete on your training record. Before entering the suite you must gown correctly, confirm the room status and the pressure differential, and check that the previous batch has been cleared. The lubricant addition must be dispensed with a second person and the press set to the parameters in the batch manufacturing record. In process checks for weight, hardness and thickness run every thirty minutes and every entry must be made at the time in the batch record.

Cass Whitmore, Pharmaceutical Production Operator
Subject: Buddy shift in the compression suite on Thursday

You are with me in the compression suite on Thursday for the next ibuprofen batch. Before we gown in, read the good manufacturing practice policy and the compression work instruction. On the day you will check the room status and pressure differential, dispense the lubricant addition with me as the second person, set up the press to the batch record, run the in process checks every thirty minutes and record everything at the time you do it. If anything is out of limit we stop and raise a deviation. Bring your training record so I can sign you off on the steps you complete.

Your brief

Prepare for and operate the compression step of a tablet batch under supervision in line with good manufacturing practice, completing the batch record entries and in process checks correctly at the time, responding to any out of limit result, and having your training record signed off for the steps completed.

Work through it

You do not need to do it all. Doing a few of these will show you what the work is like. Your ticks and notes stay on this device.

Read the Good Manufacturing Practice Policy and the compression work instruction in the batch record notes, and list the gowning and room entry checks.
Check the compression suite status, the pressure differential gauge reading and the line clearance from the previous batch, and record them in the batch record.
Dispense the lubricant addition with Cass Whitmore as the second person, checking material name, lot and quantity against the Raw Material Receipts and Stock system and the batch record.
Set up the press to the batch record parameters and record the settings, then run the start up checks and record the first in process results.
Run in process checks every thirty minutes, record each result at the time, and describe the action you would take if a result were outside the limit.
Complete the compression section of the batch record with no blank fields and single line corrections where needed, and have Cass Whitmore verify each entry that requires a second person.
Complete the shift handover report for the compression suite and have your training record signed for the steps completed.

My notes: what did I enjoy, and what surprised me?

What someone in this role would produce

Completed compression section of the batch record
In process check records
Shift handover report
Signed training record entry

Printing this is a record of what you explored. It is not a certificate or a qualification.