1.0 Purpose
This procedure outlines the requirements for cleaning and disinfection of pharmaceutical facilities.
2.0 Scope
This procedure includes, but is not limited to, floors, walls, windows, drains, and auxiliary items. This procedure also addresses the use and maintenance requirements of cleaning tools. This procedure does not address the cleaning of process equipment and pharmacies.
3.0 References
PHF-CLN-001 Management of Cleaning and Usage Records.
4.0 Definitions
Cleaning: The process of removing dirt, impurities, or contamination from surfaces using an agent (detergent or solvent).
Disinfection: The process of using an agent that kills pathogenic or other harmful microorganisms, but not bacterial spores.
Water: Refers to tap water (also known as drinking water) or higher purity.
TEGO51: A surface-active amphipathic bioagent based on alkyl diazane and alkyl triazopeptane.
TEGODOR F: A formaldehyde-free disinfectant containing a quaternary ammonium compound and a glutaraldehyde compound.
5.0 Responsibilities
Cleaning and disinfection of production areas will be performed by the pharmaceutical production department. It is the responsibility of the pharmaceutical technician in charge of cleaning operations to comply with all requirements and instructions described in this procedure. The duty supervisor/supervisory technician is responsible for ensuring compliance with this procedure.
6.0 Process
6.1 General
6.1.1 The cleaning frequency that corresponds to each area is specified in this process. (See Section 6.4)
6.1.2 Specific instructions for items listed in the frequency table. (See Sections 6.5 to 6.10 for details)
6.13 Provisions for storage, reuse and/or disposal of cleaning equipment (mops, buckets, cloths, cleaning machines, etc.). (See Sections 6.11 to 6.12 for details)
6.1.4 Instructions for recording cleaning operations. (See Section 6.15)
6.1.5 Clean at the specified frequency under normal operation; appropriate additional cleaning should be performed in non-routine maintenance, construction, and atypical situations.
6.2 Safety, Health and Environment
6.2.1 When handling diluted and concentrated chemicals, wear rubber gloves, goggles and a face shield.
6.2.2 For spills of cleaning chemicals and other emergencies, refer to the relevant safety instructions.
6.2.3 When handling cleaning tools, the risk of back injury must be taken into account.
Use manual handling equipment, where assistance is provided or requested from colleagues as required.
6.2.4 When wet cleaning in damp areas, ensure that wet-first floor signs are placed in the area and are clearly visible.
6.3 Handling Instructions
6.3.1 All cleaning agents and disinfectants work best in the concentration specified, so concentration is critical to the effectiveness of the entire cleaning process.
If the cleaning agent is too weak, the chemical will not be sufficient to trap contamination and prevent recontamination. Conversely, if the chemical is too strong, the lifting capacity will be insufficient due to the reduced water ratio.
6.3.2 Cleaners and disinfectants must be prepared before use. Diluted solutions are valid for 8 hours from the time the solution is prepared. Disinfectants cannot be stored in diluted form. Diluted storage solutions become less effective and are more susceptible to microbial growth.
6.3.3 When using a new mop, it must be disinfected according to the instructions in Section 6.11.
6.3.4 When cleaning or disinfecting, it is important to clean from the least contaminated to the dirtiest areas.
6.3.5 Low vacuum central cleaning systems can be used to remove accidental spills of raw materials or to remove residual raw material-containing materials from equipment. For serious spills of raw materials, they should be placed in industrial waste bags or cleaned up with a portable vacuum cleaner.
Note: When using a vacuum cleaner, care must be taken to manually collect and dispose of any items that may clog the vacuum cleaner. These items are not allowed to be handled by vacuum cleaners.
6.3.6 The following cleaning activities must not be performed in rooms where production is in progress: wet cleaning of floors (including disinfection), cleaning of walls, doors, fixtures and windows, drain/handwash cleaning, and cleaning of exhaust vents and ceilings.
6.4 Cleaning and disinfection of production areas
6.5 GARBAGE REMOVAL
6.5.1 Collect industrial and non-industrial waste from all garbage containers and transfer to outgoing transfer station.
6.5.2 Replace garbage bags in garbage containers.
6.5.3 Disposal of industrial solid waste shall follow SOP SHE-EMS-003.
6.6 FLOOR SWEEPING/VACUUMING
6.6.1 Identify clean walls in designated areas.
6.6.2 Sweep floors with a dust mop or broom, or clean floors with a low vacuum central cleaning system. Be careful not to create excessive airborne dust while sweeping.
6.6.3 Transfer dust to clean, dry plastic bags and seal the bags.
6.6.4 Dispose of removed dirt into a solid industrial waste container.
6.7 WET CLEANING FLOOR (INCLUDING SANITIZING)
6.7.1 Ensure wet floor markings are on the floor.
6.7.2 Ensure floors are swept/vacuumed or dusted to remove visible particles and dirt before using cleaning agents (see 6.6).
If the floor is free of dust and dirt, it does not need to be swept prior to wet cleaning.
6.7.3 When practical, place equipment, trays or benches aside. Cleaning equipment should be removed or protected (if covered) before starting the area cleaning procedure.
6.7.4 Prepare cleaning/disinfecting solution and mop the solution onto the floor (see instructions in Section 6.13).
Note: When moving to a room used for the production of a different product line, the cleaning solution, mop disinfecting/cleaning must be changed (see 6.11).
6.7.5 Allow a minimum contact time of 5 minutes before mopping the floor with water to remove any residual cleaning agent.
6.7.6 After cleaning, all residual water must be removed from the floor immediately with a squeegee.
6.8 Clean walls, doors, fixtures and windows
6.8.1 Sweep or vacuum if any dust deposits are present. Particular attention must be paid to the cleaning of doors. Ensure that all door tops are dusted and cleaned to remove any fixed dust.
6.8.2 Prepare the cleaning/disinfecting solution (as per 6.13). Using a clean wool-cleaning head, apply the cleaning/disinfecting agent to walls, doors, fixtures, and windows. Mechanical action should be used to promote cleaning. If necessary, use a cloth to remove stubborn deposits.
6.8.3 Allow at least 5 minutes of contact time.
6.8.4 Rinse the walls with water and allow to dry.
6.8.5 Use a squeegee to remove excess residual water from the walls; wipe around windows with a clean, lint-free cloth. Any wall-mounted fixtures should also be wiped.
6.8.6 Mop up any water that falls to the floor.
6.9 Cleaning Vents, Ceilings
6.9.1 Vacuum or brush vents.
6.9.2 Wipe vent surfaces with a damp, lint-free cloth.
6.9.3 Clean ceilings as you would walls (see Section 6.8).
6.10 Cleaning/Disinfecting Drains and Sinks
6.10.1 Sinks should be flushed with water after each use.
6.10.2 Remove loose solids/debris from drains where appropriate.
6.10.3 Disinfecting Drains:
6.10.3.1 Prepare sufficient diluted sodium hypochlorite (4% v/v) for cleaning drains (see 6.11.2). Ensure that the sodium hypochlorite is within its expiration date. Label the diluted solution with the brand name and concentration. Record the expiration date 8 hours from the time the solution was prepared.
6.10.3.2 Ensure that drains are clear.
Visual inspection of cleanliness is important to ensure the effectiveness of diluted bleach.
6.10.3.3 Apply diluted bleach to the inside surfaces of drains.
6.11 Mopping/Washing Floors
6.11.1 Mops and mop buckets should be treated with disinfectant before and after each use.
6.11.2 5L sodium hypochlorite (bleach) solution, prepared as follows:
6.11.2.1 Confirm that the sodium hypochlorite is within the expiration date.
6.11.2.2 Add 200ml of sodium hypochlorite concentrate to 5 liters of cold water.
6.11.2.3 Label the name and concentration of the solution. Record the expiration date 8 hours from the time the solution is prepared.
Note: The amount of solution can be increased or decreased according to the cleaning requirements, as long as the above preparation method is followed.
6.11.3 Soak the mop for at least 5 minutes. Do not soak the item for too long.
6.11.4 Rinse the mop thoroughly with purified water.
6.11.5 Wring the mop as dry as possible; make sure there are no water dripping from the mop before storing it.
6.11.6 Place the mop in a designated area to dry. Make sure the mop does not touch the floor or wall. Do not touch the mop head directly with your hands.
6.11.7 Disposal of disinfectant (see Section 6.14).
6.11.8 Rinse the mop bucket with clean water and then turn it upside down.
6.12 Disposal of cleaning tools
6.12.1 Disinfect and reuse mops and mop buckets according to the instructions in Section 6.11.
6.12.2 Discard cleaning rags at the end of the cleaning operation.
6.12.3 Wool products and rubber brooms can be reused until they are visibly worn. They must be stored in dry conditions.
6.13 Preparation of cleaning/disinfectant solutions
6.13.1 Two cleaning chemicals are used for routine disinfection of production areas: TEGO51 and TEGODORf.
6.13.2 Rotate them weekly.
6.13.3 Before preparing the solution, make sure that the concentrate is within its expiration date.
6.13.4 The 1% TEGO 51 solution is prepared by diluting 50 ml of TEGO 51 concentrate with water to 5 L.
6.13.5 The 1% TEGODOR F solution is prepared by diluting 50 ml of TEGODOR F concentrate with water to 5 L.
Note: The amount of solution can be increased or decreased according to the cleaning requirements, as long as it is prepared in proportion as described above.
6.13.6 After the solution is prepared, label it with the solution name and concentration. Record the expiration time of 8 hours from the time the solution is prepared.
6.14 Disposal of cleaning agents/disinfectants
6.14.1 Cleaning agents are disposed of by discharging them into the chemical waste pipe through drains and sinks.
6.14.2 Cleaning agents are not allowed to be discarded in the sink of the locker room.
6.15 Documentation
6.15.1 Cleaning of production operation rooms (walls, floors, drains and sinks) will be recorded in accordance with the Cleaning and Usage Record Management Procedure (PHF-CLN-001). When making cleaning records for floors/walls, attention should be paid to the use of cleaning agents.