OBJECTIVE
To lay down a procedure for operation of auto loader.
SCOPE
This procedure applies for production department in Pharmaceutical Manufacturing Facilities Formulation division.
RESPONSIBILITY
- The capsule filling operator is responsible for implementation of the process.
- The Production In-Charge is responsible for the execution of the procedure.
PROCEDURE
Assembling:
- Assemble clean and dry accessories in the following manner.
- Raceway along with the pusher slide and magazine.
- Front and back cover.
- Empty capsules hopper.
Operation:
- Ensure that all parts of the machine are cleaned.
- Load empty capsules into the hopper.
- Switch on mains of the machine.
- Fit capsules loading plate on loading table.
- Push loading plate inside by turning knot in clockwise direction. Push the green button to load capsules.
Dismantling:
Remove the front and back cover.
Remove the empty capsules hopper.
Remove magazine followed by pusher plate and raceway.
Clean machine and the dismantled parts.
All the operation details shall be entered in the equipment usage and cleaning log book.
ABBREVIATION(s)
Q.A - Quality Assurance
BL - Beta-Lactam
SOP - Standard Operating Procedure
No. - Number
P.D - Production
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