| Cleaning, operation and usage of dynamic pass box |
1.0 OBJECTIVE To lay down a Procedure for cleaning, operation and usage of dynamic pass box. 2.0 SCOPE This procedure is applicable for cleaning, operation and usage in the Quality Control Department of Microbiology Area. 3.0 RESPONSIBILITY • Microbiologist: is responsible for carrying out the established procedure • Head of Microbiology : is responsible for ensuring that the SOP is followed correctly. 4.0 ACCOUNTABILITY • Department Head • Head Quality / QA 5.0 PROCEDURE 5.1 Usage: -The usage of dynamic pass boxes depends on area in which installed, for e.g., four dynamic pass boxes as per respective aseptic area in descried here in. 5.1.1 Dynamic pass box ID No.- It is used for material transfer from controlled area to unloading cooling area. The followed by the items used in aseptic area are transferred through dynamic pass box. Like testing sample for sterility, FTGM and SCDM media tubes and dilutes, filter papers, testing aids, disinfectants, EM plates, air sampler and validation instruments etc. and following items transfer through aseptic area to uncontrolled area sterility testing tubes, EM plates and testing aids and wastage. 5.1.2 Dynamic pass box- ID No. It is used for material transfer from uncontrolled area to MLT sterile corridor. The followed by items used in aseptic area are transferred through dynamic pass box. Like testing samples for microbial limit test, media tubes and plates, disposable sterile petri plates, dilutes, filter papers, testing aids, disinfectants, microbial, validation instruments, air sampler culture tubes and slants, etc. and following items transfer through aseptic area to uncontrolled area testing tubes and plates, microbial culture and slants, plates for pre-incubation and testing aids and wastage. 5.1.3 Dynamic pass box- ID No. It is used for material transfer from autoclave unloading area to Microbial culture handling area. The following items used in culturing handling are transferred through dynamic pass box. Like sterilized media and testing aids. No any material transfers from culturing area to autoclave unloading area. 5.1.4 Dynamic pass box- ID No. It is used for material transfer from autoclave unloading area to Microbial limit testing area. The following items used in culturing handling are transferred through dynamic pass box. Like sterilized media and testing aids. No any material transfers from Microbial limit testing area to autoclave unloading area. To Read this SOP Click Here SOP for Operation and Calibration of Micropipette. 5.2 Cleaning 5.2.1 Clean and sanitize the entire dynamic pass box from aseptic area side with lint free duster soaked in 70% isopropyl alcohol. 5.3 Operation 5.3.1 Ensure that no material is present in the pass box and both the doors of pass box are closed. 5.3.2 Switch “ON” the pass box from the electric board and check that interlocking of door is properly working. 5.3.3 Switch ON from the mains to start the blower of pass box and check the reading on magnehelic gauge. It should be within range of 10-15 mm of water. 5.3.4 Open the door of dynamic pass box room controlled area side. Load the items to be transferred to aseptic area and close the door and enter in aseptic area. 5.3.5 Keep the items to be transferred under UV light inside the pass box at least 15mintes. 5.3.6 Inform the person on t 5.3.7 the other side for unloading the items in aseptic area. 5.3.8 Open the door of dynamic pass box from aseptic area side, unload the items and close the door. 5.3.9 Record the details of pass box cleaning, UV light burning hours and differential pressure monitoring in the format no. XXX. 5.4 Qualification frequency: – every yearly month by outside party. |
