sop for Machine operation capsule inspection and polishing machine
1. PURPOSE & SCOPE : To lay down guidelines for operation of capsule Filling machine.
2. RESPONSIBILITY
Production Officer
3. AUTHORITY
Production manager
4. PROCEDURE :
MACHINE NAME: Semi automatic Capsule Filling Machine M/C No.:——-
The entire Machine Operation is divided in three stages :
a. Pre – operative Cleaning & Setting.
b. Operation
c. 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. Below the releasing chute, collection bag in plastic drum is kept.
e. The container containing the polished capsule is brought near the machine
STAGE – II
a. The capsule inspection & polishing machine is switched on and run for few seconds to observe whether if it is running normally or not.
b. If any abnormal sound is heard the machine is referred to maintenance dept. for
rectification.
c. The machine is started & the capsule is released from hopper to the inspection belt & after inspection the capsules are passed through the polishing machine.
d. The process is continued till the entire batch is polished.
STAGE – III
a. After the day’s operation or Production change or change of composition all the contact parts like hopper, chute, channel and loading pin etc, are thoroughly cleaned & 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 I.
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
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
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
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
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
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
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt