1.0 Introduction
Line clearance aids in preventing mix up of containers or products or the components and mistakes during manufacturing product
1.1 Stages:
Line clearance procedures comprises of three stages
1.1.1 Clearing – Here materials or items from previous production are removed from the line like product, labels, packed products, printed cartons, batch coding, left over solution etc.
1.1.2 Cleaning – Cleaning should be done after cleaning of materials or items from previous production.
As per the standard operating procedure cleaning is done
The equipment is cleaned as per SOP and the rinse water is sent for analysis to quality control
1.1.3 Checking – After cleaning the line or area is checked and is recorded in batch manufacturing record.
Any failure should be recorded and investigation should be done regarding the same
Each process should have a checklist or form for each area or line
The person in charge of clearance should be informed of any occurrences before the area is cleared
After the clearance is given then it should be displayed on status board or signed and recorded
1.2 Live line clearance:
This process involving placing of dummy articles in the line or area after checking is done. When an operator search for dummies and if all the dummies are not found then it indicates the need to modify the checklist or procedures.
Dummies should not be confused for genuine article and strict proceduralised control is necessary
QA personnel should be trained on live line clearance before the procedure is implemented and the personnel should be evaluated twice in a year for their performance
1.3 The following stages in production involve line clearance procedure
Dispensing, decartoning, washing, manufacturing, filling, leak test, batch coding, packing
1.3.1 Before Dispensing
The dispensing area should be checked as to no equipment’s, accessories, materials remain from previous operations
Any paperwork, status labels from previous activity should be removed
The reverse laminar air flow booths and the surroundings should display the clean status
Accessories and equipment should be labelled as clean
1.3.2 Before Blending or Capsule Filling & Inspection or Tablet Inspection or Compression or polishing
Before starting the process in areas for the above activities the line should be free from materials, residues, utensils, accessories, containers, paper works, and status labels. Equipment should be cleaned and the status should be displayed.
1.3.3 Before Over printing
The areas should be free from materials or stereos and paper work
1.3.4 Primary and Secondary Packaging
Before primary and secondary packaging the area should be cleaned and any materials or accessories from previous operations should be removed
Status labels, paper work, stereos should be removed
All the equipment should be cleaned with clean status label
Areas should be cleaned with status label displayed
Line clearance, clearing, cleaning,checking, live line clearance,over printing,primary and secondary packaging, dispensing
