Medical Devices

6. Buildings and Environment

INTRODUCTION
PERSONNEL TRAINING
BUILDINGS
     Repackers, Remanufacturers, Contract Sterilizers, and Relabelers
     Contamination Control
     Orderly Operations
ENVIRONMENTAL CONTROL
     General Controls
     Analyze Operation
     Specifications
     Monitoring
CONTAMINATION CONTROL
     Personnel Sanitation Practices
     Prevent Contamination by Hazardous Substances
     Personal Practices
EXHIBITS
     Clean Room and Work Station Procedure
     Cleaning Procedure for the Aseptic Filling Room

INTRODUCTION

The buildings and environment in which components, devices, and records are received, processed, built, or stored, and the personnel that perform these operations should be controlled so that finished devices will consistently meet the specifications established by the manufacturer. The degree of control should allow for appropriate changes in such elements as temperature, humidity, bioburden, particles, personnel, components, devices, and records.

PERSONNEL TRAINING

Personnel play an important role in orderly operations and environmental control. They can reduce or increase contamination. Thus, personnel can positively or negatively impact most of the points made in this chapter. To reduce problems and increase the state-of-control, employees shall be appropriately trained regarding orderly operations and environmental control as required by 820.25 and as discussed in Chapter 5.

BUILDINGS

Facilities of medical device manufacturers and their contractors in which components, inprocess devices, accessories, and finished devices are handled, processed, and stored shall have sufficient space and be designed to allow proper cleaning, maintenance, and other necessary operations in order to meet the requirements of 21 CFR 820.70 of the Quality System (QS) regulation. Buildings should be suitably designed so that there is adequate space for manufacturing, receiving, packaging/labeling, storage, etc., to: minimize contaminants; assure orderly handling procedures; and prevent mixups. As the company grows or the product line is changed, existing facilities may become inadequate. Thus, as part of the quality assurance program audit, existing buildings should be reviewed to determine if space and facilities are adequate in light of growth or changes in production

Repackers, Remanufacturers, Contract Sterilizers, and Relabelers

The GMP requirements for buildings extend to manufacturers that repackage and/or relabel unpackaged bulk devices, contract sterilizers, and remanufacturers that change the original condition of devices. The number of operations needed to repackage or relabel a product may be less than for actual manufacturing of a product; nevertheless, there is a need to design and arrange facilities so that repackaging and/or relabeling operations, particularly for sterile devices, can be performed in a controlled manner. Because remanufacturing of devices is manufacturing, the GMP requirements for buildings and facilities extend to areas where modifications are performed. In some manufacturers these modifications are done in cluttered repair shops. Under these conditions, there is an increased probability for contamination or mixup, hence such manufacturers should take appropriate precautions as required by the QS regulation.

Contamination Control

Typical problems in manufacturing and storage facilities include environmental contamination and insufficient space for receiving and holding incoming products before testing and inspection [820.70(c) and 820.70(e) and 820.70(f)]. For each area in the building where products are processed, any elements such as particulates from cardboard dust, byproducts from slitting or cutting operations, microorganisms, humidity, temperature, static electricity, etc., which a manufacturer has determined might cause contamination should be controlled. Buildings should be appropriately constructed to prevent, reduce, and control potential contaminants and support the environmental control program as discussed later. For example, the control of dust may require that driveways and parking lots be paved. Crowding causes mixups and can result in contamination or in the use of unapproved or rejected products. Designated areas should be assigned for various production activities such as receiving, inspection/testing, manufacturing, labeling, packaging, record keeping, etc. Traffic by personnel who do not work in or manage the designated areas should be held to a minimum.

Orderly Operations

In addition to having sufficient space, the facility shall be designed and arranged so that all operations can be performed in an orderly manner [820.70(f)]. This will facilitate the satisfactory performance of all operations. In manufacturing areas, it prevents confusion that can lead to unsatisfactory job performance and mixups. The goal is for a smooth flow of operations.

To preclude mixups, distinct operations or processes should be separated either physically, by walls or partitions, or spatially, by providing enough room between operations to indicate that separate activities are being performed. An appropriate degree of separation, or walls, curtains, etc., should exist so that no activity will spray, dust, or otherwise have an adverse effect on other adjacent activities. For example, there should be a handling and storage system to preclude the mixup of labeled "sterile" but notyetsterilized devices from the same type of devices that have been sterilized. Manufacturers that have more than one labeling operation should maintain adequate separation of these to prevent any mixups occurring between various products and their specified labeling. Labeling mixups are a major cause of product recalls and a number of these mixups can be traced to inadequate separation of operations during the labeling of devices.

ENVIRONMENTAL CONTROL

One of the variables that can significantly affect product quality and employee performance is the environment. A controlled environment is, to various degrees, an integral part of most production facilities. Some environmental factors to be considered are lighting, ventilation, temperature, humidity, pressure, particulates, and static electricity. Section 820.70(c), Environmental Control, of the QS regulation, is considered by FDA to be a "discretionary" requirement; that is, the degree of environmental control to be maintained should be consistent with the intended use of the device and details of how to achieve this control are left to the manufacturer to decide. "Discretionary quality system requirements" are those which may or may not apply to the manufacturer of a specific device. In these cases the manufacturer should decide whether implementing such requirements is necessary to assure the quality of the finished device. These requirements are modified in the QS regulation by phrases such as "where environmental conditions could reasonably be expected to have an adverse affect" and "adequately control."

General Controls

General air conditioning is normally not regarded as an environmental control; however, changes in temperature and lighting can have an adverse effect on employee performance and, in turn, on assuring that the device is properly assembled, inspected, and tested. Air conditioning can control humidity which, in turn, can affect the generation of static charges. Static charges can damage some electronic components and, in such situations, need to be controlled [820.70(c)]. Production workers are a major source of particulate contamination and standard operating procedures for personnel are often necessary in order that employees not adversely affect the environment.

Analyze Operation

If the environment in which devices are manufactured or held can have an adverse effect on the devices' fitness for use, that environment shall be controlled [820.70(c)]. For each operation, the manufacturer should analyze the manufacturing operations to identify controls needed for the finished device to meet the device specifications and be fit for the intended use; and to control costs. For example, in the manufacture of sterile devices such as implants, or diagnostic media that requires aseptic filling, the environment should be controlled to reduce viable microorganisms and particulate matter. The packaging for sterile devices should be stored in a clean, dry, insectfree area. Components that support bacterial growth should be stored in a controlled environment which, in some cases, will include refrigeration.

Because particles can bridge across sub-micron circuits and static electricity can rupture semiconductor junctions, microcircuits for use in devices should be manufactured in a stringent cleanroom environment where particulates and humidity are controlled. When analyzing the production of a device to determine the degree of control needed, the manufacturer should identify exactly what needs to be controlled:

the device itself;
the area for one task; or
the large production area.

For example, if the device can be cleaned after production, there usually is no need for extensive environmental control during production. If the cleaned devices are stored in clean containers or are immediately packaged, the environment usually should be controlled where the device is being packaged. If the work area needs to be controlled, how much should be controlled a work bench, room, or factory? For example, a HEPA filtered laminarflow bench maintains a lowparticulate environment that is large enough for many small tasks or operations. If a larger area is needed, then it may be possible to set a broad environmental specification for most of the room or area. A small laminarflow unit and curtains can create a small, but very clean area. Considerations such as these can reduce environmental facility and equipment costs and reduce the activities required to maintain and monitor the controlled area and operations.

Specifications

When it is necessary to control the environment, specifications for parameters such as temperature, humidity, colony forming units (CFU's), and particulates per cubic foot, etc. should be established. No FDA guidances for these parameters presently exist for environmentally controlled areas such as clean rooms. "Federal Standard Airborne Particulate Cleanliness Classes In Clean room and Clean Zones" (FED-STD-209E) with its appendices is suggested as a resource for developing clean room standards such as particle counts per cubic foot. Federal Standard 209E defines various levels of environmental control such as Class 1000. A Class 1000 room contains no more than 1000 particles 0.5 micron diameter or larger per cubic foot of air. Information may also be obtained from manufacturers of clean room equipment. Aseptic manufacturing and filling are usually done in a Class 100 or better clean room or bench. The Class 100 status is maintained during routine operations. During idle periods the particle count will generally be much lower than 100. Some manufacturers use a Class 10,000 clean room for the assembly and packaging of devices that will be terminally sterilized and where a low particulate count on the devices is desired. The specifications for such a room could be:

Particulates:	Maximum of 10,000 of 0.5 micron diameter or larger per cubic foot
Humidity:	45 +/ 5 percent
Temperature:	72 +/ 2.5 degrees F
Air Velocity:	90 feet/minute +/ 2 percent
Air Pressure:	0.05 inches water between the clean room and other areas

For assembly of many types of convenience kits and assembly of medical devices that need to be free of visible particles, many manufacturers use an "industrially clean area or controlled environment area." Such rooms are air conditioned and use furnace filters and, in some cases, pre-filters of much finer porosity than furnace filters are also used. The temperature is controlled by a standard room thermostat. Humidity variations are limited by common air conditioning. True air conditioning with cooling below the dewpoint and reheat are not necessarily used. Air velocity is determined for the air conditioning; and the room is known to have positive pressure with respect to other areas by a flow or pressure indicator. A particle class is not specified. However, these manufacturers have established a controlled environment and appropriate specifications for temperature, cleaning, and contamination controls are in place. For example, filters should be replaced per schedule or as needed based on scheduled inspections. Any practices or factors from the following list that the manufacturer has deemed appropriate and elected to use should be specified and routinely performed or followed. Some additional factors that should be considered when planning and using a controlled environment include:

proper attire and dressing anteroom;
controlled use of, and entry into, controlled areas;
prohibiting eating, drinking, smoking, or gum chewing;
preventing use of lead pencils;
regulating the storage of glassware and containers;
preventing or controlling the cutting, tearing or storage of cardboard, debris, etc.;
cleaning the room and production equipment per written procedure;
the original design and cleaning of work surfaces and chairs;
selecting correct furniture and eliminating all nonessential equipment;
controlling room air quality (amount of particulates, pressure, velocity, and exchange rate);
eliminating electrostatic charges by controlling work surface composition or grounding;
ensuring cleanliness of raw materials, components and tools;
controlling the purity, sterility, and nonpyrogenicity of process water; and
maintaining prefilters, HEPA filters, and electrostatic precipitators.

Also see at the end of this chapter the procedure, "Clean Room and Work Station Procedure," which covers work practices, dress codes, and hygiene for employees working in clean rooms or at laminarflow benches.

Monitoring

An appropriate system for regular monitoring should be established and maintained for each of these factors to be controlled for a given operation. This will ensure that equipment is performing properly and that the quality of the environment is within specifications. When a particle count Class is specified, monitoring of airborne particulates is usually done with an air sampler. Monitoring of work surfaces for microbes [colony forming units] may be done with surface contact plates or settling plates. However, settling plates should not be used for monitoring when horizontal laminar air flow is used as they are ineffective for this type of flow.

All sampling should be done per written procedure, and the data should be recorded. Further, periodic inspections of environmental controls and documentation of the inspections are required by the QS regulation. The inspection checkoff form or other record should be kept simple.

CONTAMINATION CONTROL

The QS regulation requires in 820.70(e) that every manufacturer establish and maintain procedures to prevent contamination of product or equipment. These process specifications are established by the manufacturer to ensure that finished devices will meet the company's quality claims. Typical device examples are: in vitro devices that are not contaminated with microbes, detergents or rodenticides; circuits that are not contaminated with flux; implants that are not contaminated with body oils and certain implants that are not contaminated with pyrogens. Pyrogens are substances that cause fever in humans, and they arise primarily from cellular debris of gram-negative bacteria.Certain implants such as orthopedic implants are not required or expected to be pyrogen free. Other devices are required to be nonpyrogenic including: transfusion and infusion assemblies, devices that come in contact with circulating blood or cerebrospinal fluid, intraocular lenses and the surgical instruments used in their implantation, and any device labeled as "nonpyrogenic". Manufacturers should carefully control the environment in which such devices are manufactured and processed to minimize contamination with bacteria or establish a procedure for cleaning the devices.

If necessary for the device to meet company product specifications or labeling claims, cleaning procedures and schedules to meet the requirements of section 820.70 may need to be written. Each operation should be analyzed in order to write an appropriate procedure or determine that one is not needed. For example, written procedures are usually not required for cleaning floors and work benches in areas where nonsterile and nongrowth promoting components or devices are processed and packaged. An example of a procedure and schedule for cleaning an aseptic filling room is exhibited at the end of this chapter. Records related to facilities, the environment and personnel practices need to be kept simple as shown by this example. Note that the schedule and record of cleaning are both on page 4 of the procedure. The record of cleaning may be a checkmark, initial, or signature. Where a checkmark is used for repetitive work, companies commonly require that the person's name be on the record at least once. The schedule for cleaning may be posted or filed as long as it is in a convenient location. As appropriate, manufacturers may use this procedure as is, modify it, or use it as a guide to develop a procedure to meet specific needs.

Personnel Sanitation Practices

Adequate bathroom, dressing, storage, and waste facilities should be provided, as appropriate, for personnel to maintain the needed level of cleanliness [820.70(d)]. Such facilities should be maintained on a regularly scheduled basis. Where necessary, such as in a clean room, special clothing and an area to don and store the garments should be provided. Clean room clothing is not be worn into uncontrolled rooms or outside the facility.

Prevent Contamination by Hazardous Substances

If rodenticides, insecticides, or other hazardous substances are used, written procedures to limit their use or for their removal from work surfaces and devices should be established to prevent any adverse affect on the manufacturing process or the device [820.70(e)].

Personal Practices

If eating, drinking, or smoking could have an adverse affect on the devices' fitness for use, manufacturing procedures should include instructions on how to avoid such adverse effects [820.70(d)]. For example, these activities could be confined to specially designated areas such as a lunch room or employees lounge. Directions and containers or equipment should be provided for timely and safe disposal of trash, byproducts, effluents and other refuse.

EXHIBITS

Reprinted on the following pages are two examples of procedures that may be used to comply with the cleaning or contamination control requirements of the QS regulation. Both of these procedures deal with sensitive areas of the plant: clean room and aseptic filling rooms. Therefore, these are more comprehensive than is normally needed for general plant cleaning.

Note that these procedures follow good labeling practices in that the tasks or rules are broken into numbered steps; and only one or two activities or rules are included in each step. Thus, the directions or rules are easy to read, remember, and execute or obey.

Clean Room and Work Station Procedure

This procedure is divided into general requirements, non-laminar airflow clean rooms, and workstations, laminar airflow clean rooms and workstations, and clean room personnel rules. The first part of this procedure contains useful information for any area of a plant were moderate control is needed to reduce particulate contamination. The level of control needed increases as the procedure goes from non-laminar airflow to laminar airflow. The final section contains additional requirements for personnel working in a clean room.

Cleaning Procedure for the Aseptic Filling Room

This is a standard operating procedure used by personnel that are charged with cleaning an aseptic filling area and not for personnel that generally work in this area. This cleaning procedure is divided into two sections, daily and weekly tasks, thus giving personnel guidance on when, as well as, how to perform these tasks. Please note that many manufacturers will alternate the germicide in their cleaning solution to minimize the likelihood of resistant organisms developing. There are two items of interest in this procedure that should help to minimize entering and exiting this area: the equipment list at the beginning, and the maintenance information at the end. The equipment list is important because it alerts personnel to obtain the proper equipment before beginning work. The maintenance procedures allow the personnel to perform maintenance tasks without calling in a special crew or having to exit and re-enter the room unnecessarily.

Sheet 1 of 3

PROCEDURE TITLE: Clean Room and Work Station Procedure No.______ Rev._________

Prepared by ________________________ Approved by ____________________ Date ________

A. General Requirements

1. No eating, drinking, smoking, or chewing gum.

2. Specified garments must be worn when entering and inside the clean area. These shall be stored in the anteroom and not worn in nonclean areas.

3. Only approved clean room paper shall be allowed in the area.

4. Use only ballpoint pens (fine point preferred).

5. Rouge, lipstick, eye shadow, eyebrow pencil, mascara, and false eyelashes shall not be worn by any worker while in any clean area.

6. No cosmetics of any kind are to be applied or removed in the clean area.

7. Skin lotions or lanolin-base soaps are in the restrooms for employees to use to guard against flaking due to dry skin.

8. Solvent contact with the bare skin should be avoided, as most solvents will remove the natural skin oils and cause excessive skin flaking.

9. The use of paper or fabric towels is not recommended -- washrooms should have electrically powered, warm-air dryers.

10. Approved pliers, tweezers or lint-free gloves must be used to handle manufacturing materials, components, or finished devices.

11. Do not touch with gloves or finger cots any covered or uncovered part of the body, or any item or surface that has not been thoroughly cleaned.

12. All containers, racks, jigs, fixtures, and tools should be cleaned to the same level of cleanliness specified for the device being processed.

Sheet 2 of 3

B. Non-laminar Airflow Clean rooms and Work Stations

1. Garments shall be pocket-less, lintfree coveralls, with snug fitting fasteners at the neck, wrist, and ankles.

2. Lintfree caps must be worn and must completely cover the hair and head except for the eyes, nose, mouth, and chin.

3. Shoes shall be cleaned and covered with a nonshedding boottype cover or changed to approved clean room footwear. If special footwear is provided, it shall not be worn outside the clean room and dressing room.

4. Janitorial services shall be performed only by adequately trained and supervised personnel, each of whom must be properly garbed.

5. All equipment to be brought into the clean room shall be qualified for clean room use and first be thoroughly cleaned. Use only equipment that will minimize the generation of contaminants.

6. Traffic into and within the clean room shall be restricted to authorized and properly garbed personnel, and unnecessary movements by these personnel shall be minimized.

C. Laminar Airflow Clean Rooms and Work Stations

1. Garments may vary with the operation being performed, but the minimum garment shall be a pocket-less, lintfree smock which extends to at least 15 inches below the work surface. The collar and cuffs shall have fasteners.

2. Head covering shall be worn, and shall completely cover the hair. If the operation requires the wearer to lean over the work, or move into the airstream between the filter bank and the work piece, the front, sides, and rear neck areas of the head shall also be covered.

3. Shoe covers are not necessary for vertical or horizontal laminar airflow facilities except when the work is being performed less than 24 inches from the floor.

4. A face mask may be needed if an operator has a cold, or if the nose and mouth must be brought very close to the work piece for work on miniature components or devices. Check with your supervisor for instructions.

Sheet 3 of 3

D. Clean Room Personnel Rules

Personnel will be asked to cooperate in maintaining a low contaminant emission rate by observing the following rules.

1. Bathe at night, instead of in the morning, to allow the build-up of normal body oils which reduces skin shedding. Also, use skin lotions.

2. Wear clean, unstarched, lowshedding garments.

3. Where appropriate, shave daily and be clean shaven or wear appropriate hair covering.

4. Avoid touching, rubbing, and scratching exposed areas of the body.

5. Exercise extra care to rid the hands of normal residue from home duties such as starching, baking, plastering, wallpapering, painting, concrete work, carpentering or other particulate generating activity.

6. Request duty outside the or away from the clean room area when you have a cold or other viral or bacterial infection.

1 of 4

STANDARD OPERATING PROCEDURE: Number G021 Revision A

TITLE: Cleaning Procedure for the Aseptic Filling Room

APPROVED BY: __________________________ Date: ___________________

PURPOSE: Control of surface contamination within the Aseptic Filling Room.

EQUIPMENT NEEDED:

1. Cleaning solution: See SOP G044

2. Nonlinting wiping cloths

3. Stainlesssteel basins and pails

4. Drywet vacuum cleaner for floors

(should be equipped with a HEPA filter on the exhaust air port to filter the exhaust air)

5. Sponge mops with replaceable sterile heads

6. Mop buckets

7. Stainlesssteel sponges

8. Powder free latex surgical gloves, sterile

9. Head and shoe covers, sterile

10. Face masks and gowns, sterile

11. Stainlesssteel cart

12. Sprayer

13. Trash can plastic liners

14. Stepladder

DAILY CLEANING REQUIREMENTS:

CAUTION: Be careful when using stepladder and when walking in wet areas. USE EXTREME CARE WHEN CLEANING ELECTRICAL FIXTURES AND OUTLETS. USE DAMP (NOT WET) CLOTH TO WIPE ELECTRICAL ITEMS.

A. Gowning Room:

Shoe and head covers are required in this area. Begin all cleaning at the top and finish at the bottom of any equipment or surface to be cleaned.

1. Empty trash containers and replace plastic liners.

2. Replenish stock of shoe covers, masks, head covers, gowns, gloves and put into proper areas.

3. Fill dispenser with 0.45 u filtered 70% Isopropyl alcohol.

4. Mix cleaning solution of XXXXXXXX using process water (SOP G044).

Page 2 of 4

5. Fill a stainlesssteel basin with cleaning solution and begin wiping in this order: the boot box; stool; wash station; top and outsides of all cabinets; counter tops; and the tops of the trash containers.

6. Remove excess debris and wet mop the floor with cleaning solution.

7. Fill sprayer with cleaning solution and wet the floor; allow it to air dry.

8. Gown according to gowning procedures and go into the filling area (SOP G014).

B. Filling Room:

1. Move any remaining products (devices) to appropriate areas as directed by your supervisor.

2. Empty all trash containers and replace liners.

3. Remove particulate matter from ledges, cabinets and external surfaces of laminarflow benches with a wiping cloth and cleaning solution.

4. Perform general cleaning and organization of shelves.

5. Remove debris and wet mop the floor with cleaning solution.

6. Spray the entire floor in the filling room with cleaning solution, using the provided sprayer. Allow the floor to air dry.

WEEKLY CLEANING REQUIREMENTS:

All daily cleaning requirements are included in the weekly cleaning requirements. The additions to the weekly cleaning are ceilings, walls, and the internal work surfaces of the laminar-flow work benches. Rodac™ plate measurements are taken after cleaning and before the next production shift.

A. Gowning Room:

1. Use only one entrance and one exit when cleaning. The cleaning direction will flow from entrance to exit.

2. Remove all nonessential equipment from the room and clean it. Return the equipment after the entire area is cleaned.

3. Begin cleaning the room by wiping the entire ceiling area with the cleaning solution.

Frequent changes of the cleaning solution and the wiping cloths are needed for effective cleaning of large areas such as the ceilings and walls. Make new solution and change wiping cloths when dirty.

1. Clean air vents, lighting fixtures, and sprinkler heads.

Page 3 of 4

1. Clean the walls next, starting at the top and cleaning toward the floor.

2. When the ceilings and walls are cleaned, follow steps 1, 2, 3 and 5 of the Daily Cleaning Requirements for the gowning room.

3. Remove debris and wet mop the floor with cleaning solution.

4. Fill the sprayer with cleaning solution and wet the floor. Allow to air dry.

5. Gown according to procedure and go into the Filling room (SOP G014).

B. Filling Room:

1. Follow steps 1, 2, 3 and 4 of Daily Cleaning Requirements for Filling Room.

2. Begin cleaning operation by wiping the entire ceiling area with cleaning solution. Make new cleaning solution and change wiping cloth when visibly dirty.

3. Clean air vents, ultraviolet and fluorescent lighting fixtures and sprinkler heads.

4. Clean the ultraviolet bulb since any oil or dust on the bulb drastically reduces its germicidal properties.

5. Clean the walls next, starting at the top and cleaning toward the floor. Make new cleaning solution, and change wiping cloth when dirty.

6. Empty all shelves and wipe with the cleaning solution. Wipe the removed materials and put them back onto the cleaned shelf.

7. Wipe all cabinets and equipment with the cleaning solution from top to bottom.

8. Wipe all ledges and surfaces with the cleaning solution.

9. Pay particular attention to the laminarflow workbenches because the cleaning operation should start in the internal work surface of the hood as it is the cleanest area.

Use a fresh wiping cloth and cleaning solution for the internal work surfaces. Do not use the same cloth or solution which was used for the external cleaning. Discard solution and wiping cloths after cleaning each hood.

1. First, switch off the laminarflow hood, then clean all outside surfaces from top of hood to bottom stand. Discard cleaning cloth.

2. Second, clean all internal work surfaces with a new cleaning cloth in this order:

a. Air diffuser screen

b. Workbench top.

c. Plexiglas sides

d. Light covers

3. Clean the floors. Scrub stains or spills first, with stainlesssteel sponges, to loosen debris. Use the sponge mop to clean the loosened debris. Fill the sprayer with cleaning solution and wet the entire floor area. Allow to air dry. Rodac™ plate measurements are made after cleaning and before the next production shift.

4. Complete the documentation ledger and sign it. See Attachment A.

Page 4 of 4

C. Maintenance of Cleaning Equipment After Daily and Weekly Cleaning:

1. Use the same solution as used for general cleaning.

2. Wipe stepladder from top to bottom, in that order, and put it into storage cabinet.

3. Wipe stainlesssteel basins and pails with cleaning solution, allow to air dry, and put into storage cabinet.

4. Rinse mops and buckets with cleaning solution. Do not leave dirty solution in buckets or vacuum cleaner.

5. Rinse sponge mops with warm water. If mop head needs replacing, replace it and put mop into storage cabinet.

6. Wipe stainlesssteel cart with cleaning solution and put into storage cabinet.

7. Rinse sprayer with cleaning solution and put into storage cabinet.

8. Rinse vacuum cleaner with cleaning solution. Remove filters and clean with cleaning solution. Replace filters and clean nozzle. Put into storage cabinet.

9. Autoclave mop heads and buckets per procedure GAC 09.

ASEPTIC FILL DEPARTMENT CLEANING RECORD Week of
AREA	ITEM	SUN	MON	TUE	WED	THU	FRI	SAT	WKLY
GOWNING ROOM	Empty waste containers
	Remove dirty uniforms
	Wipe ceilings
	Clean UV lights
	Wipe walls
	Clean floors
FILL ROOM	Empty waste containers
	Straighten shelves
	Wipe ceilings, walls & ledges
	Clean UV lights
	Clean floors
AIR LOCKS	Wipe ceiling & walls
	Clean floors
CLEAN FILL RM	Empty waste containers
	Wipe ceilings & walls
	Clean floors
POOLING AREA	Empty waste containers
	Wipe ceilings, walls & ledges
	Clean UV lights
	Clean floors

Indicate task completed each day by a check mark in appropriate box. Shift Supervisor: _____________________________