Dr . Ashraf SelimDC , IC&P

Member in IFIC , ESIC , EDA

Central Sterilization Supply Department

CSSD

Cleaning Zone

Preparation / Packing Zone

Storage Zone

General Planning ConceptsSPD is the first line of defense against harmful microorganisms. Contamination prevention is achieved by closely monitoring the following elements:

1. Air Flow: To minimize microorganism movement from dirty to clean areas. In clean areas there is a positive air flow.

2. Staff Flow: Personnel work either on the clean side or the dirty side of the SPD unit to avoid cross contamination.

3. Work Flow: Refers to the movement of clean (sterile) supplies and the return of contaminated items for decontamination and sterilization.

Criteria

1. There shall be a changing area include shower facilities, toilet facilities and lockers in proximity to the decontamination area.

2. Access to the wash room and to the clean room shall be through separate dedicated gowning rooms provided with hand hygiene facilities.

3. The finishes on the walls and other surfaces shall be flush, smooth, non-linting, water resistant and able to withstand frequent cleaning.

4. Floors shall be covered in a washable non-slip material which is securely sealed.

7. There shall be adequate lighting.

8. All work surfaces, fittings, fixtures and furniture shall be made of easily cleanable and disinfected .

9. The workstations shall be of adequate size to accommodate the wrapping material to be used and shall be height adjustable.

10. There shall be adequate space between workstations for equipment and staff movement.

The environmental parameters

a) The ACH shall be at least 10 times per hour.b) The Humidity should be 35-70 %.c) The temperature should be maximum 18 - 22 °C.d) The air pressure must be Negative in relation to the

surroundings in Dirty zone and Positive in clean and sterile / storage zones.

e) The overpressure should be 10 -15 Pa.f) The overpressure shall be measured at least once a year

Point Of Use

Transportation

Initial flushing soaking (Pre-

Cleaning )

Cleaning

Drying

Inspection

Monitoring & Packaging

Sterilization

Storage

Transportation

Sterilization Cycle

Transportation

Transport contaminated instruments to the processing area in a manner that minimizes the risk of exposure to persons and the environment. • Use a rigid, leak-proof container. • Use appropriate personal protective equipment.

Cleaning

Principles and methods of cleaning

Factors involved in cleaning action :

1. Chemical energy: detergent , enzymatic detergent 2. Mechanical energy: friction3. Thermal energy

Manual cleaning

Steps: Sorting, soaking, washing, rinsing

Procedure:a) All items should be dismantled before cleaning.b) Soaking in detergent for 10 min.c) Thorough brushing with soft brush with long handle keeping the brush below the surface of waterd) Rinsing with warm water

Disadvantages of manual cleaning

1. Not effective enough.2. No Standardization. 3. Subject HCWs to injury from handling sharp

Instruments4. Cause minute scratches to the instruments.5. Brushes must be disinfected after each use.

Ultrasonic cleaning (The microscopic "brush“)

It is like brushing at a speed higher than the vibrations of sound. It has the advantage that the cleaning action can take place at any location in or on an instrument where water can reach.

An ultrasonic cleaner works mostly by energy released from the collapse of millions of microscopic cavitations near the dirty surface.

The bubbles made by cavitations collapse forming tiny jets directed at the surface.

Never use Ultrasonic cleaner withFlexible endoscopeElastic materials: rubber ware and materials of silicon.

Testing performance:Aluminum foil test or Chemical indicator for checking cavitation

Washer-Disinfectors

Test performance (TOSI test)

Drying of instruments

Drying reduces the risk of re-contamination.

Residual moisture interferes with the sterilization process, and can damage instruments.

Following any method of cleaning (pre-cleaning, manual, mechanical and ultrasound) instruments need to be dried.

Drying cabinets should be used for drying instruments operating temperatures shall be within the range 65°C to 75°C.

Hot air drying may also occur during the last stage of the cycle of washer/disinfector machines.

Instrument inspection

After completion of the cleaning process instruments must be dried then inspected.

1. Visually to ensure the process of cleaning.2. Functional Inspection: Instruments must be

inspected for working performance.

Packaging of instrumentsPackaging materials (e.g., wrapped or container systems) allow penetration of the sterilization agent and maintain sterility of the processed item after sterilization.

Materials for maintaining sterility of instruments during transport and storage include wrapped perforated instrument cassettes, peel pouches of plastic or paper, and sterilization wraps (which can be either woven or unwoven).

Packaging materials: 1. Soft/flexible packaging materials /disposable.2. Rigid packaging systems / reusable either Drums or

Containers

Papers

Papers including bleached crepe paper and wraps combining cellulose and synthetic fibers are commonly used packaging materials for steam, dry heat and ethylene oxide sterilization. They are permeable to steam, air and chemical vapors and provide an effective barrier if the packs are stored in clean, dry conditions.

Paper is unsuitable for use in the hydrogen peroxide plasma method of sterilization as it absorbs the hydrogen peroxide vapor from the chamber space, thus interfering with subsequent generation of hydrogen peroxide plasma during the cycle.

Hydrogen peroxide plasma Only purely synthetic packaging materials (Tyvec) can be used in hydrogen peroxide plasma sterilization.

Laminated film pouches

Use: Primary packaging for individual instruments or small

instrument sets. The pouches consist of a sheet of paper or non-woven and a

sheet of laminated transparent plastic, which are sealed together.

The film cannot be penetrated by steam or air. Removal of air and penetration of steam is through the paper/non-woven.

Sterilizing containers

1. Air removal and steam access through filters or valves. They ensure maintenance of sterility during storage.

2. They provide an effective mechanical protection during handling and transport

3. Labeling system offers clear identification of the content, production data etc.

4. A tamper protection device shall give clear indication whether a container was opened

 

Heat sealer

1. Where heat seal packaging is to be used, a rotary heat sealer shall be provided.

2. The heat sealer shall be validated and tested daily to verify the efficacy of the seal.

Instrument Loading

Rigid containers should not be stacked.

Trays of surgical instruments should be placed flat on the sterilizer shelf so that the position of the instruments within the trays can be maintained.

Textile packs should be placed in the chamber so that the content folds are at right angles to the sterilizer shelf to enhance the process of conditioning.

Storage

Store instruments in a clean, dry environment in a manner that maintains the integrity of the packageThe physical storage conditions are designed to maintain the sterility of processed items in relation to temperature, relative humidity, ACH, and relative pressure

Storage shelves: 18 inches from ceiling 8 – 10 inches from the floor At least 2 inches from outside wallStorage Time

Time related protocol / (first in, first out ) For many years a sterile storage time of four weeks has been the tradition, followed by recall, repacking and reprocessing of all facility manufactured stock not used within four weeks of sterilization. (1983. )

Event relatedThe product should remain sterile until some event causes the item to become contaminated (e.g., a package becomes torn or wet)The CDC currently makes no shelf-life recommendations for sterile packs…

“Knowing is not enough; we must apply.

Willing is not enough; we

must do.”