Tablet Manufacturing

SOP for operation of Tablet Storage and Handling Equipment

Standard Operating Procedure for Operation of Tablet Storage and Handling Equipment

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the proper operation and handling of tablet storage equipment to ensure the storage conditions meet the required specifications, prevent contamination, and maintain the quality of the tablets during storage.

2. Scope

This SOP applies to all personnel involved in the operation and handling of tablet storage equipment, including warehouse staff, quality control personnel, and other relevant employees.

3. Responsibilities

  • Warehouse Staff: Responsible for operating the tablet storage equipment as per this SOP and ensuring that tablets are stored in the designated areas correctly.
  • Quality Control (QC) Personnel: Responsible for conducting regular checks on the storage conditions and ensuring compliance with the required standards.
  • Production Supervisor: Responsible for overseeing the tablet storage process and addressing any concerns related to storage and handling.
See also  SOP for Deduster Screen Replacement and Calibration

4. Procedure

4.1 Preparation of Tablet Storage Equipment:

  • Before using the tablet storage equipment, ensure that it is clean, sanitized, and free from any residues from previous storage.
  • Check the temperature and humidity settings of the storage equipment and ensure that they are calibrated and set to the required storage conditions for the specific tablets.
  • Inspect the storage equipment for any physical damages or malfunctions that may affect the storage environment.
  • Ensure that the storage area is well-organized, with clear labeling and segregation of different tablet batches.

4.2 Loading and Unloading of Tablets:

  • When loading tablets into the storage equipment, handle them with care to prevent breakage or damage.
  • Use appropriate containers, such as clean and approved bins or trays, to store the tablets inside the equipment.
  • Avoid overloading the storage equipment to maintain proper air circulation and prevent compression or deformation of the tablets.
  • Ensure that tablets with different batch numbers or expiry dates are properly segregated and stored separately.
  • During unloading, check the tablets for any abnormalities or damages, and report any issues to the production supervisor or QC personnel.
See also  SOP for Batch Sampling and Testing

4.3 Monitoring and Maintenance:

  • Regularly monitor the storage equipment’s temperature and humidity levels to ensure they remain within the specified range.
  • Keep a log of temperature and humidity readings as part of routine monitoring and quality control procedures.
  • Perform scheduled maintenance and cleaning of the storage equipment to ensure its proper functioning.
  • Address any equipment malfunctions or deviations from the required storage conditions promptly and report them for resolution.

5. Abbreviations

SOP: Standard Operating Procedure
QC: Quality Control

6. Documents

The following documents are relevant to this SOP:

  • Tablet Storage Equipment Manual
  • Storage Area Organization Plan
  • Storage Equipment Maintenance and Calibration Log
See also  SOP for Blending Process

7. References

No specific external references are required for this SOP as it is based on internal company procedures and industry best practices.

8. SOP Version

This is version 1.0 of the SOP for Operation of Tablet Storage and Handling Equipment, effective as of [Insert Date].

Related SOP's: