Pharamceutical line clearance

1. Line Clearance

2. INTRODUCTION
LINE CLEARANCE AIDS IN PREVENTING MIX UP OF
CONTAINERS OR PRODUCTS OR THE COMPONENTS
AND MISTAKES DURING MANUFACTURING PRODUCT.

3. Stages:-
Line clearance procedures comprises of three stages-
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.
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

4. 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

5. The following stages in production involve line
clearance procedure -
Dispensing, decartoning, washing, manufacturing,
filling, leak test, batch coding, packing
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

6. 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.
3.Before Over printing -
The areas should be free from materials or stereos and
paper work

7. 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.