Standard Operating Procedure for Using Walk-in Stability Chamber
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the walk-in stability chamber in the pharmaceutical manufacturing of otic dosage forms to ensure the controlled storage conditions for stability studies.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of walk-in stability chambers in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the walk-in stability chamber as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the temperature and humidity to ensure they remain within the required range.
Maintenance Personnel: Responsible for maintaining the walk-in stability chamber in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the walk-in stability chamber for cleanliness and integrity before use.
4.1.1.2 Ensure that the temperature and humidity monitoring devices are functional and calibrated.
4.1.1.3 Check that the door seals are intact and there are no leaks.
4.1.2 Preparation
4.1.2.1 Clean the interior surfaces of the chamber with a suitable disinfectant.
4.1.2.2 Turn on the chamber and allow it to reach the desired temperature and humidity before placing any materials inside.
4.1.2.3 Set the desired temperature and humidity range as per the stability study requirements.
4.2 Operation
4.2.1 Storing Materials
4.2.1.1 Label all materials clearly with the name, date, and storage conditions.
4.2.1.2 Place the materials on the shelves without overcrowding to allow proper air circulation.
4.2.1.3 Monitor the temperature and humidity regularly to ensure they remain within the specified range.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate personal protective equipment (PPE) when handling materials to be stored.
4.2.2.2 Avoid frequent opening of the chamber door to maintain stable conditions.
4.2.2.3 Follow all safety protocols to prevent contamination or accidents.
4.3 Post-operation
4.3.1 Removing Materials
4.3.1.1 Remove materials from the chamber as needed and record their removal.
4.3.1.2 Ensure the door is closed securely after removing any items.
4.3.1.3 Document any deviations in temperature or humidity or storage conditions.
4.3.2 Cleaning and Maintenance
4.3.2.1 Regularly clean and disinfect the interior and exterior surfaces of the chamber.
4.3.2.2 Inspect the chamber for any signs of wear or damage and repair or replace components as necessary.
4.3.2.3 Calibrate the temperature and humidity monitoring devices periodically to ensure accuracy.
4.3.2.4 Document all cleaning and maintenance activities in the walk-in stability chamber log.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Walk-in stability chamber log
Temperature and humidity monitoring records
7) Reference, if any
Manufacturer’s manual for the walk-in stability chamber
Pharmacopeial guidelines for stability studies in pharmaceutical manufacturing
8) SOP Version
Version 1.0
