Title Page

  • Process Name

  • SOP #

  • Department

  • Location
  • Conducted on

  • 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

The templates available in our Public Library have been created by our customers and employees to help get you started using SafetyCulture's solutions. The templates are intended to be used as hypothetical examples only and should not be used as a substitute for professional advice. You should seek your own professional advice to determine if the use of a template is permissible in your workplace or jurisdiction. You should independently determine whether the template is suitable for your circumstances.