sop for operation of capsule loading machine semi-automatic
1. PURPOSE & SCOPE
To lay down guidelines for operation of capsule loading Machine .
2. RESPONSIBILITY
Production Officer
3. AUTHORITY
Production Manager
4. PROCEDURE
Machine Name : CAPSULE LOADING MACHINE M/C No. :___
The entire Machine Operation is divided in three stages :-
i) Pre-operative Cleaning & Setting
ii) Operation
iii) Post Operative Cleaning and equipment preparation
STAGE – I
a. The exterior of the machine is cleaned with dry cloth.
b. The electrical connections are restored by pulling the plug top into the socket.
c. The “Machine Ready for use” sticker is removed and sticker/tag showing product, Batch No. etc. is put on the top cover of the machine.
d. The container containing the capsule of required size and colour are brought near the machine.
e. Load the capsules into the hopper.
f. Fix the loading plate below the chute.
STAGE – II
a. The capsule loading machine is switched on and runned for few seconds to observe whether it is running normally or not.
b. If any abnormal sound is heard the machine is referred to maintenance deptt. for rectification.
c. In other case the machine is started and the capsule is out and loaded into the loading plate.
d. When the plate is completely filled with capsules remove the plate.
e. In case of batch changeover the contact parts are cleaned by clean cloth.
STAGE – III
a. Incase of product changeover all the contact parts like hopper, chute, channel, loading pin etc. are thoroughly cleaned and washed with the D.M. Water.
b. The connection is then cut off by taking out the plug top from the socket.
c. A sticker stating “Machine ready for use” is put on the machine to render it ready for use.
A logbook is kept for each machine of operation in the format given in Annexure 1
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
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sop for Cleaning of Bins and Containers
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sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
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sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
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sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
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sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt