Tablet Compression SOP

• Process Name

• SOP #

• Department

• Location
  Address

• Conducted on

  Date

• Prepared by

Purpose

• [SAMPLE ONLY. You may customize this template based on your business requirements]
  
  The purpose of this SOP is to ensure that the correct steps are taken when using the tablet press to perform tablet compression.

Scope

• The scope of a manufacturing SOP answers the following questions:
  
  1. Where is the SOP to be used? e.g. area, process, department, stage? --- (chemical manufacturing lab)
  2. Who is the SOP for? e.g. operator, manager, QA --- (lab personnel and tablet press operators)
  3. Are there any specific limitations or exceptions to this SOP? (This only applies to the production of pharmaceutical tablets)

Cleaning of tablet press

• Compression machine was cleaned as per separate SOP (use 70% isopropyl alcohol)

  ✔

  ✖

• Dust extractors, pipes, racks, door frames, and return filters of the Air Handling Unit have all been cleaned

  ✔

  ✖

• Performed visual check for absence of leakage

  ✔

  ✖

• After receiving approval from quality control department, put "cleaned" label on equipment

  ✔

  ✖

Operation

• Remove "cleaned" label prior to operating tablet press.

  ✔

  ✖

• Affix label to tablet press with PRODUCT NAME and BATCH DETAILS

  ✔

  ✖

• Issue the punch set suitable for the compression as per separate SOP.

  ✔

  ✖

• Set the machine as per tablet parameters given in BMR.

  ✔

  ✖

• Destroy tablets from first few rotations before starting the machine for the first batch.

  ✔

  ✖

• Collect tablets generated per batch then pack and label

  ✔

  ✖

• Stop compression as material in the hopper reaches the lowest level.

  ✔

  ✖

• Clean all outside containers and store them with labels that show batch details.

  ✔

  ✖

• Remove punch sets and clean as per separate SOP.

  ✔

  ✖

Completion

• Full Name and Signature of Employee

  Sign