Why line clearance is important in pharma

why line clearance is important I pharm

“Line clearance” concept is followed in pharma companies generally for packaging operations. Since there are multiple packaging lines in a company, this is very important activity.
Its main objective is to ensure that line is ready to perform next packaging operation and there are no chances of product & packaging components mix-ups.
It ensures following aspects ,
-The packaging line is free from previous product units

  • It is free from previous packaging materials (previous packing operation)
  • The entire line is cleaned, sanitized, cleared & maintained as per SOP
    -Environmental conditions are adequate (Room conditions- Temp. / RH etc)
  • The packaging machines are free of any material of previous batches
    -The machines are cleaned as per SOP
  • The line is ready for next batch / product packing operarations
  • To ensure correctness of packaging components and product units of next operation.
    These activities are performed by production / packaging operators, supervisors and verified by Quality Assurance person(s) as per their checklist / SOP. Upon satisfactory observations QA should certifiy line clearance and record the activity in the Batch records.
    Similarly, this concepr is used for ensuring readiness of production / processing unit operations such as Granulation & Drying, Lubrication, Compression, Coating of tablets etc. This is also known as “Area Clrearance”
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In pharmaceutical before starting any new work its permission is required by qualified persons of production and QA.They inspect the area free from previous products,cleaning,equipments and req documents etc and after ensuring QA person allow to start work.

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