| Transfer Of Environmental Monitoring Kits |
1.0 OBJECTIVE To lay down a Procedure for transfer of environmental monitoring kits and water sampling kit to & from sterile manufacturing facility. 2.0 SCOPE This procedure is applicable for transfer of environmental monitoring kits and water sampling kit to & from sterile manufacturing facility in the Quality Control Department of Microbiology Area. 3.0 RESPONSIBILITY • Microbiologist : is responsible for preparation of trends as per SOP. • Manager microbiology : is responsible for ensuring that the SOP is followed correctly. 4.0 ACCOUNTABILITY • Department Head • Head Quality / QA 5.0 PROCEDURE 5.1 Environment monitoring kits shall be transferred to the sterile manufacturing facility for the environmental monitoring, have the following items. 5.1.1 Media filled petri plates -90mm for sterile exposure. 5.1.2 media filled Rodac plate (contact plates) for surface & personnel monitoring. 5.1.3 Sterile swab 5.1.4 Air sampler To read this sop click here SOP for Physical Monitoring Of Microbiology Laboratory. 5.2 Method of Transfer 5.2.1 The outer surface of the SS petri plate carrier shall be sanitized with filtered 70% IPA. 5.2.2 The SS petri plate carrier shall be transferred to the production facility. 5.2.3 In the production facility the outer surface of the SS petri plates carrier shall be sanitized again with filtered 70% IPA. 5.2.4 After the sanitization the SS petri plates carrier shall be kept in the pass box for a period of 10minites. 5.2.5 Microbiologist shall enter the critical area as per approved entry and exit procedure. 5.2.6 Microbiologist shall open the pass box form the critical area side and again spray the 70% IPA outer surface of SS container. 5.2.7 The SS petri plate carrier shall be opened and inner SS stands containing the petri plate shall be removed and petri plates shall be exposed for area monitoring. 5.2.8 After the exposure period, microbiologist shall cover all the exposed petri plates and shall arrange the plates in the SS stands in the critical area. 5.2.9 The SS stands containing the exposed plates shall be put in the SS petri plates carrier in the pass box. 5.2.10 Microbiologist shall exit the critical area and/or shall bring back the SS Petri plate carrier to the Microbiology laboratory. 5.2.11 The exposed Petri plates shall be removed from the inner SS stand and shall be arranged and incubated in the respective incubator in an inverted position. 5.2.12 The SS stand and SS Petri plate carrier shall be given for cleaning and subsequent sterilization for the next use. 5.2.13 Sanitize the outer surface of Air sampler with by 70% IPA, and keep the air sampler in polybag. 5.2.14 Follow the steps 5.2.2 to 5.2.7. 5.2.15 Than perform air sampling as per location after that clean the outer surface of air sampler with help of 70% IPA and kept in pass box. 5.2.16 Pick the air sampler from pass box, kept in polybag, bring back in microbiology lab, and kept in safe place. 5.3 Water sampling kits shall be transferred to the sterile manufacturing facility for the water sampling in the critical area, have the following items. 5.3.1 Sterile water bottles 5.3.2 Sterile gloves. 5.3.3 Mask 5.3.4 Stop watch 5.4 Method of Transfer 5.4.1 Follow the same steps 5.2.2 to 5.2.10 5.4.2 The water sample container sanitized with 70% IPA and kept in microbiology testing area pass box. Microbiologist entry in area as per entry and exit SOP. And take the water sampling kit and removed water sample from the container and perform testing. |