SOP for Control Environment Chamber (40 °C/75 % RH) : Pharmaguideline

Online GMP Courses with Certificate

ENROLL

SOP for Control Environment Chamber (40 °C/75 % RH)

Standard operating procedure of Control Environment Chamber used to store the stability samples at 40 °C and 75 % RH.

1.0 OBJECTIVE

To ensure that the humidity chamber performs satisfactorily and maintains required temperature and relative humidity for stability study samples.

2.0 SCOPE

This SOP is applicable to the humidity chamber performs satisfactorily and maintains required temperature and relative humidity for stability study samples.

3.0 RESPONSIBILITY

Microbiologist - Quality Control

4.0 ACCOUNTABILITY

Manager - Quality Control

5.0 PROCEDURE

5.1 Procedure for general cleaning
5.1.1 Ensure the power supply to the humidity chamber is switched 'OFF'.
5.1.2 De-dust the chamber externally with a clean dry cloth.
5.1.3 Once a week remove adhered dust by wet mopping using detergent solution.
5.1.4 Subsequently wipe the surface with a clean dry cloth to remove trace of detergent.
5.1.5 Once in a month, mop the interior surfaces with a clean dry cloth.
5.2 Operating procedure
5.2.1 Ensure that the humidity chamber is properly connected to the power supply.
5.2.3 Check the water supply to the humidity chamber
5.2.4 Switch 'ON' the main switch and the power switch of the chamber
5.2.4 Set the temperature of the chamber to 40° C by pressing the 'READ' switch (red color and adjust the desired temperature with the set knob.
5.2.5 Similarly set the humidity of the chamber to 75% by pressing the 'read' switch (green color and adjust the desired humidity with the set knob.

5.2.6 Ensure that thermohygro sensor is used as follows:
5.2.6.1 The sensor should be in a clean condition i.e. without any dust or moisture on it.
5.2.6.2 Monitor the conditions of the chamber by recording the temperature and humidity daily.
5.2.6.3 Report if the temperature shows beyond 40°C + 2° C and humidity 75% + 5% RH during monitoring to Quality Assurance Manager and notifies the defect to Engineering Department. Put an 'out of order' label on the chamber. Transfer the stability samples to the standby oven within 2 hours.

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
Get ready to use editable documents in MS-Word FormatView List





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


1 comment: Post Yours! Read Comment Policy ▼

  1. How many times we calibrate stability chambers in a year

    ReplyDelete

Please don't spam. Comments having links would not be published.


Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
Online Courses


Follow Pharmaguideline


DOCUMENTS

PHARMACEUTICAL DOCUMENTS




Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

View


adsbypg


Recent Posts