Standard Operating Procedure for Working in Sterile Area Prepared by: Microbiologist Approved by: Q. C.

Manager Reference: SOP Guidelines

SOP #. Effective Date: Rev. #: Rev. Date: Page 1 of 3

Purpose
It is established to describe outlines the gowning procedure that must be followed by each and every person who enters to Sterile Area. The procedure is designed to reduce the risk of contaminating product with bacteria and/or non-viable particles.

Scope
It is applicable for Microbiological Laboratory and also for Injectables.

Responsibility
Sterile Area Incharge Production Operators Microbiologist Micro-lab Assistant Each person who enters Sterile is responsible for following the procedure as set out below.

Procedure
o Sterile filling (high grade) Environmental (Authorized and Validated Staff only). o Entry into this area should be managed by the Microlab team. o Higher Environmental Grade uniforms consists of : Company approved and provided undergarments, Sterile hood, Sterile surgical mask, Sterile coverall, Sterile designated safety shoes, Sterile overshoes, Sterile gloves, Safety glasses. o Sterile Preparation (medium grade) Environmental (Authorized and Validated Staff only). o Entry into this area should be managed by the Microlab team. o This environmental grade area include : Sterile Area Scrub Preparation Rooms, Sterile Air Lock, Component or Equipment Preparation rooms,

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Dispensing booths, Sterile Solution Preparation rooms, Medium Environmental Grade uniforms consists of : Blue smocks/coveralls, Shoe covers over Factory safety shoes, or designated shoes, No Street clothes, which includes -shirts, unless this is a clean one, worn as a singlet. Upon Entry into the Sterile Scrub Change Room: o Wash hands and face with a good detergent soap, every day before starting to work. o Fingernails must have been properly cut. o All injury cuts liable to exposure to microorganisms must be properly medicated and covered. o Eating, drinking, smoking, handling contact lenses, applying cosmetics are not permitted. o Persons wear in contact lenses must wear goggles or face mask while in the active work area. o All outer clothing is to be removed including shoes and socks down to approved undergarments, which must be worn; all this is to be placed onto racks on the "dirty" side of the dividing seat. Remove any band-aids from small, uninfected cuts and discard into rubbish bin. o Take left or right glove and holding the folded -over inner section, insert fingers of left or right hand. o Pull glove up onto middle of hand. o Repeat with left or right glove. o Fold-over top section of glove. o Clip the straps at the knee of the overshoes with gloved hands taking care not to touch the outside material of the overshoe. NOTE Sterile overshoes are used per shift only. o YOU ARE NOW READY TO ENTER THE STERILE AREA. NOTE o Thin rubber gloves are worn throughout Sterile to minimize bacterial and particulate contamination. o Their use is not an answer to all microbial contamination problems, but an aid to quality production. o Regular use of sterile 70% IPA is essential for the maintenance of cleanliness and sterility, etc. o Gloves are to be sprayed regularly with sterile 70% IPA - approximately every 10 minutes, before entering any Laminar Air Flow area and before and after handling equipment. o Gloves must be replaced: On re-entering Sterile after a break. If the glove is holed, soiled or having touched any dirty area, e.g. floor. If additional comfort is required.

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After conducting a glove print for the Microbiology Laboratory. Along with clothing after Breakdown Maintenance. NOTE Gloves and mask must be replaced if the operator sneezes in the sterile room. o Mechanical or autopipetting devices or to be used when handling dangerous material. o All procedure must be performing carefully to minimize the generation of aerosols. o Decontaminate all work surfaces on which tests are performed, before and after work done (with 70% sterile IPA). o Before disposal all contaminated liquid and solid waste must be decontaminated by an approved method. o All people must wash their hands with a disinfectant soap or detergent after handling viable material. o Preferably use Gloves to handle viable material. o All disinfectants must be handled with care wear rubber gloves during preparation or use. o Follow safety precautions where needed. o All hazardous material must be handled as per safety requirement. o An effective program for the control of insects and rodents must be followed. o Access to the lab is restricted; all unauthorized personnel must not be allowed to enter. o Incharge may only permit entrance. o Use S.S. trays and carts for the transfer of material from one place to other to minimize accidents.

Environment and Health Safety Statement

SAFETY GLASSES and gloves are to be worn in the Glass Sterile and when IPA is used. NOTE o Should you be suffering any infection or illness you must report this to your Process or Production Manager who will consult with the Microbiology and / or QA Manager to determine whether you may work in the sterile areas. Similarly, if you have been ill, you may not enter the sterile area unless cleared to do so by the Microbiology Laboratory Quality Manager or QA Manager. o Safety shoes are to be worn at AL L TIMES in Sterile.

Record
Not applicable.