1.0 OBJECTIVE : To set up a standardized general procedure for the operation and cleaning of Air Shower Pass Boxes.
2.0 SCOPE : This SOP is applicable for the operation and cleaning of Air Shower Pass Boxes (ID. No. QC/138 & QC/139) used in the microbiology laboratory of Quality Control department of Beximco Pharmaceuticals Limited, Track-II.
3.0 RESPONSIBILITY
3.1 Operating personnel is responsible for carrying out the procedure.
3.2 Overall responsibility for training, implementation & follow-up with the QC Manager or his/her nominee.
4.0 ACCOUNTABILITY
4.1 Head of Quality.
5.0 PRECAUTIONS
5.1 Always be careful during opening and closing of Air Shower Pass Boxes.
5.2 Particular attention should be paid to avoid cross contamination of air.
6.0 PROCEDURE
6.1 The operation of the Air Shower Pass Boxes shall be done as per the following procedure.
6.1.1 Ensure the main power supply line is “ON”.
6.1.2 Check that the green indicator light is “ON”.
6.1.3 Pull the handle of the lock to open the door of the Pass Box.
6.1.4 The red indicator light will be “ON” and the green indicator light will be “OFF”.
6.1.5 Put the items on the pass box.
6.1.6 Lock the pass box by pushing the door handle.
6.1.7 Check that the green indicator light is “ON” and Air is showering for 10 sec.
6.1.8 After the showering of Air being completed, unlock the Air Shower Pass Box from the other side (clean side) and remove the desired items.
6.2 Cleaning procedure of Air Shower Pass Boxes
6.2.1 Clean inside of the Air shower Pass box after every day’s work with clean cloth soaked with disinfectant.
6.2.2 Clean outer surface and all parts of instrument carefully once a week.
6.3 Revalidation procedure
6.3.1 The revalidation of the air shower pass boxes shall be done as per the predefined requirements and procedures described in the approved protocol of each of the equipment.
6.3.2 Revalidation Frequency Once in every five years.