sop for Machine operation capsule inspection and polishing machine

 

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 BATCH MANUFACTURING

sop for placebo batch

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

sop for Sanitization of Seals

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 equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

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

sop for Cleaning and operation of spray gun and assemble

sop for Fogging in Aseptic and Non Aseptic Area

Leave a Comment

error: Content is protected !!