Guide5.1

Operating sequence

Follow this sequence for every batch. Record results in the batch record as you go.

Step	Stage	Key requirements
1	Hygiene & PPE	Wash hands. Wear approved PPE. Remove jewellery and personal items.
2	Room preparation	Verify room cleaning status. Complete line clearance. Check temperature and humidity. Review the batch record.
3	Machine inspection	Verify machine cleanliness. Check guards, safety switches, vacuum, compressed air and tooling. Confirm the correct capsule-size parts are fitted.
4	Machine set-up	Install tooling. Set dosing parameters. Load empty capsules. Run a jog (inching) test.
5	Powder loading	Load the approved blend. Carry out a trial run and adjust fill weight if required.
6	Production	Start the machine. Monitor powder flow and capsule locking. In-process checks every 30 minutes.
7	QA sampling	Collect start, middle and end samples and submit to QA.
8	Batch completion	Stop the machine. Recover remaining product. Label all materials correctly.
9	Cleaning	Clean to the cleaning SOP. Carry out ATP verification if required. Apply CLEAN status labels.
10	Documentation	Complete the batch record and cleaning records. Obtain supervisor and QA approval.

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