STANDARD OPERATING PROCEDURE Title: Work instructions for sterile Mfg sections

1. Purpose
1.1 Instructions are established to provide guidelines to personnel working in sterile manufacturing sections (ampoule section general, ophthalmic section, sterile powder filling section and ampoule section for hormones) for proper control of contaminants in the sections.
1.2 It is established to control contamination caused by work habits of personnel.
1.3 To give clear regulations for clean room work.
2 Scope
2.1 It is applicable in Sterile Mfg Areas.
3 References
3.1 Change Procedure for Sterile Area (GL/SOP/P/013)
3.2 Cleaning of Sterile Area (GL/SOP/P/016)
3.3 Procedure for Shoe Washing (GL/SOP/P/012)
3.4 Shoes Change Procedure in Sterile Mfg Section (GL/SOP/P/017)
4 Responsibilities
4.1 Production Pharmacist
4.2 Supervisor
4.3 Worker
5 Procedure
5.1 General Instructions
5.1.1 Only relevant & authorized personnel are permitted to enter the section.
5.1.2 Use specified entrance/exit when entering or exiting the section.
5.1.3 Use only washed/clean shoes (specified for the section & kept in entrance shoe rack); change shoes following the written SOP.
5.1.4 Always use door handles to open or close the doors.
5.1.5 Don’t perform de-cartoning in ampoule or vial washing area.
5.1.6 Wear neat & clean uniform only.
5.1.7 Don’t smoke, eat, drink or chew any thing.
5.1.8 Don’t spit.
5.1.9 If you feel unwell don’t tell your in-charge.
5.1.10 Avoid fast motion in section.
5.1.11 Avoid sneezing, coughing etc.
5.1.12 Don’t work with open wounds, cuts or skin infection.
5.1.13 Avoid unnecessary motions.
5.1.14 Avoid singing, whistling, or shouting.
5.1.15 Keep the work place clean.
5.1.16 Avoid accumulation of scrap (such as empty card board cartons), or other fiber shedding items.
5.1.17 Avoid unnecessary storage of items like tools, aluminum foil rolls, tapes, dusters, stationery etc.
5.1.18 Strictly follow the work instructions given by section in-charge.
5.1.19 Keep your teeth, ear, nose, or nails clean.
5.1.20 Wear masks, gloves or other protective wears (where applicable) properly.
5.2 Clean Room (Sterile Area) Regulations
5.2.1 A list of personnel who are allowed to enter sterile area must be maintained by the section in-charge.
5.2.2 A list of approved items for sterile area must be maintained by the section in-charge.
5.2.3 Personnel must get personnel hygiene certificate from section in-charge prior to work in sterile area.
5.2.4 All personal items such as keys, watches, rings, matches, lighters and cigarettes should be stored in the personal locker outside the sterile buffers.
5.2.5 Valuable personal Items such as wallets may be permitted in the sterile area provided they are NEVER removed from beneath the sterile area garments.
5.2.6 NO eating, smoking or gum chewing allowed inside the sterile area.
5.2.7 Only autoclaved uniform should be worn when entering.
5.2.8 NO cosmetics shall be worn in the sterile areas. This includes: rouge, lipstick, eye shadow, eyebrow pencil, mascara, eye liner, false eye lashes, fingernail polish, hair spray, mousse, or the heavy use of aerosols, after shaves and perfumes.
5.2.9 Only approved sterile area paper/document shall be allowed in the sterile area.
5.2.10 Approved ball point pens shall be the only writing tool used.
5.2.11 Use of paper or fabric towels is prohibited.
5.2.12 Gloves should not be allowed to touch any item or surface that has not been thoroughly sterilized/disinfected/cleaned.
5.2.13 Only approved gloves, pliers, tweezers should be used to handle product. Finger prints can be a major source of microbial contamination.
5.2.14 Solvent contact with the bare skin should be avoided. They can remove skin oils and increase skin flaking.
5.2.15 All tools, containers and fixtures used in the cleaning process should be cleaned to the same degree as the sterile area surfaces. All of these items are a source of contamination.
5.2.16 NO tool should be allowed to rest on the surface of a bench or table. It should be placed soaked with or dipped in disinfectant.
5.2.17 Only sterile area approved wipers are allowed to be used. The wipers must be approved for the Class of sterile area being cleaned.
5.2.18 ALL equipment, materials and containers introduced into a sterile facility must be subjected to stringent sterilization prior to entrance.
5.2.19 NO ONE who is physically ill, especially with respiratory or stomach disorders, may enter a sterile room.
5.3 Personal Actions Typically Prohibited in Sterile Area
5.3.1 Fast motions such as running, walking fast or horseplay.
5.3.2 Sitting or leaning on equipment or work surfaces.
5.3.3 Writing on equipment or garments.
5.3.4 Removal of items from beneath the sterile area garments.
5.3.5 Wearing the sterile area garment outside the sterile area.
5.3.6 Wearing torn or soiled garments.
6 Quality Record
6.1 List of approved personnel for sterile area (QF/000/01)
6.2 List of approved items for sterile area (QF/000/01)
6.3 Personnel hygiene certificate (QF/000/01)