OBJECTIVE
To lay down a procedure for the operation of the autoloader.
SCOPE
This procedure applies to the production department in the Pharmaceutical Manufacturing Facilities Formulation division.
RESPONSIBILITY
The capsule-filling operator is responsible for the 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 the mains of the machine.
- Fit capsules loading plate on loading table.
- Push the loading plate inside by turning the knot in a clockwise direction. Push the green button to load capsules.
Dismantling
- Remove the front and back cover.
- Remove the empty capsule hopper.
- Remove the magazine followed by the pusher plate and raceway.
- Clean the machine and the dismantle parts.
- All the operation details shall be entered in the equipment usage and cleaning log book.
ABBREVIATION
Q.A - Quality Assurance
BL - Beta-Lactam
SOP - Standard Operating Procedure
No. - Number
P.D - Production
ANNEXURE
Nil
REVISION HISTORY
Nil
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