Follow
1.0 OBJECTIVE : To lay down the entry and exit procedure for microbiological laboratory.
2.0 SCOPE : This SOP is applicable for Microbiological Laboratory of Quality Control Department of (Company Name).
3.0 RESPONSIBILITY
3.1 Microbiologist/QC Officer shall be responsible for carrying out the activity as per procedure.
3.2 Overall responsibility for training, implementation and follow-up with the QC Manager or his nominee.
4.0 CCOUNTABILITY
4.1 Head of Quality
5.0 PRECAUTIONS
5.1 No unauthorized person is permitted to enter into the microbiology laboratory.
5.2 Check the cleanliness of garments before wear.
5.3 Don’t step on the floor with bare foot.
6.0 PROCEDURE
6.1 Entry into and Exit from Microbiology Laboratory (Applicable for entry & exit into media store room, media preparation room, sterilization room, instrument room, incubator room, refrigerator room, change room-I, disposal room). [As shown in the pictorial form in Annexure-I]
6.1.1 Remove the street footwear and keep it in the shoe rack outside the microbiology laboratory.
6.1.2 Wear sandal and enter into the change room-I.
6.1.3 Sit on the stainless steel stool. Remove the sandal and wear shoes taking from shoe rack. Then wear cap followed by apron.
6.1.4 Look at the mirror to check the proper gowning and compare with the QA approved picture displayed on the wall
6.1.5 Disinfectant the hands with 70% filtered IPA and then entered into the room from the changeroom-I.
6.1.6 To exit from the Microbiological laboratory, exit through change room-I. Remove the cap and apron and put into the bucket.
6.1.7 Finally remove the shoes and put into the shoe rack & exit from the change room-I.
6.2 Entry into and Exit from the Micro Lab (LAF room) [As shown in the pictorial form in Annexure-II]
6.2.1 Follow the entry procedure stored in step 6.1.1 to 6.1.5.
6.2.2 Enter into the change room-II.
6.2.3 Remove the cap and apron and hang them on the hanger.
6.2.4 Remove the shoes and put them in the unclean side of the step over bench.
6.2.5 Cross over the step over bench, wear shoes taking them from the clean side of the step over bench.
6.2.6 Wear head cover and then mask followed by apron and booties.Wear hand gloves & rinse with 70% filtered IPA.
6.2.7 Look at the mirror to check the proper gowning and compare with the QA approved picture displayed on the wall.
6.2.8 Enter into microlab (Laminar Air Flow workstation) through buffer room. Rinse the gloves with 70% filtered IPA before performing any tests.
6.2.9 To exit from the Micro Lab, exit through the buffer room and enter into the change room-II.
6.2.10 Remove shoes and keep it into the clean side of the step over bench.
6.2.11 Cross over the step over bench and remove the head cover, face mask, overall, booties and hand gloves and put them into the bucket.
6.2.12 Take the shoes of the unclean side from honey comb of the step over bench.
6.2.13 Wear cap and apron.
6.2.14 To exit from the microbiological laboratory, exit through change room-I by following steps 6.1.6 to 6.1.7.
