Beruflich Dokumente
Kultur Dokumente
BY
CHRISTINA RAJU
CONTENTS
1. Introduction
2. Methods of cleaning
3. Cleaning system
4. Cleaning equipment's
5. Cleaning by chemicals
6. Research article
7. Summary
8. Reference
INTRODUCTION
• CLEANING : Cleaning is the processes of removing unwanted substances,
such as dirt, infectious agent, and other impurities, from an object or
environment
• Cleaning is broadly achieved through mechanical and solvent action
• Aspects of cleaning in industry: All the equipment's and area used during the
manufacture shall be cleaned and sanitized at appropriate level
METHODS OF CLEANING
WASHING : Usually done with water and often some kind of soap
WET CLEANING: Safe detergents and non toxic spot remover used
ACOUSTIC CLEANING: Use of sound waves to shake particulates loose from a surface
CARBONDIOXIDE CLEANING
DRY CLEANING: Chemical solvent
FLAME CLEANING: Oxyacetylene flame
GREEN CLEANING: Environmentally friendly methods
PLASMA CLEANING: Energetic plasma
STEAM CLEANING
Before undertaking any cleaning , it is important to
identify
All areas of the property that require cleaning
The scope of cleaning required
The time of day when cleaning can be undertaken
Types of surface to be cleaned
CLEANING SYSTEM
1. Clean out of place systems(COP)
2. Clean in place system(CIP)
3. Central cleaning systems(CCS)
1. CIP SYSTEM
CIP is a method of cleaning the interior surface of pipes, vessels,
processes equipment's , filters and associated fittings without
dissemble
HISTORY
Up to the 1950 closed systems were dissembled and cleaned
manually
In 1950 CIP has fully automated systems with include
programmable logic , controllers , multiple balance tanks ,
sensors, valve, heat exchangers and specially designed spray
nozzle systems
Simple manually operated CIP systems can still be found in used
today
CIP DESIGN PRINCIPLE
Based on solid load and processes geometry
Deliver highly turbulent , high flow rate solution to effect good cleaning
(applies to pipe circuits and some filled equipment)
Deliver solution as a low energy spray to fully wet the surface
(applies to lightly solid vessels ,static spray ball used)
Deliver a high energy impinging spray
(applies to highly soiled or large diameter vessels ,dynamic spray
device used)
Factors affecting the effectiveness of cleaning
Temperature of the cleaning solution: Elevating the temperature of
a cleaning solution increases its dirt removal efficiency
Concentration of a cleaning agent : Concentrated cleaning
solution much better than dilute one due to increased surface
binding capacity
Contact time of the cleaning solution: Increase the contact time
detergent eventually dissolve the hard stains
Pressure exerted by the cleaning solution(turbulence): The creates
abrasive force that dislodge stubborn soil from the dirty surface
BIOREACTOR , FERMENTERS AND MIX VESSELS
CIP commonly used for cleaning bioreactor , fermenters, mix vessels
and other equipment's used in biotech , pharmaceutical , food and
beverage manufacturing industries
CIP is performed to remove previous cell culture batch components ,
control bioburden and reduce endotoxin level
DISADVANTAGE
CIP system have a higher cost
Needs a professional personnel to operate
Once you start cleaning you cannot stop the processes
2. COP SYSTEM
COP system are used to clean pieces of equipment that
would not be touched by the CIP systems
Equipment's are fittings ,clamps , product handling untensils
,tank vents, pump rotors , impellers ,casings , hoses etc
COP uses the same cleaning solutions as CIP
Equipment's needs to be dissembled for cleaning typically
equipment's is small , complex or difficult to clean
METHODS
Immersion washer is the primary equipment
Long tanks use spray jets to create high speed turbulence and
detergent to scrub ingredients and processed material from parts
submerged in the tanks –ultra hot water
The deep sinks allow for soaking, immersion in sanitizing solutions
and final rinsing before reassembly of parts
ADVANTAGE
Usually lower investment than CIP system
Delivers consistent results
Provides a cost savings over manual cleanings , saves on time,
chemical, and water usage
Minimizes operator exposure to high temperature and strong
chemical concentration
DISADVANTAGE
More labor force(disassembly and reassembly)
Loading/unloading the COP washer
3. CENTRAL CLEANING SYSTEM
Many plants using foam cleaning apply it using mobile systems
This are two categories
Trolley mounted pressurized vessels which rely on a cleaning
operative to make up the foaming solution to the correct
strength and require a separate hose to be used for rinsing
High pressure cleaners which are fitted with a foaming device
and still rely heavily on high pressure to do the cleaning
Major draw back require long length of air and water hose to be
connected during cleaning
1. AUTOCLAVE
Autoclave is a pressurized device designed to heat aqueous
solutions above their boiling point at normal atmospheric pressure
to achieve sterilization
Auto- self
Clavis- self locking device
Autoclave is used to remove microorganisms and spores using high
pressure and temperature steam sterilization
PRESSURE = TEMPERATURE
When pressure increased in a closed vessel the temperature
increases proportionately(15 pounds pressure the temperature rises
to 1210c
PURPOSE OF THE AUTOCLAVE
1. To prepare materials for bacteriological cell cultures
without contamination
2. Prepare elements used for taking sample
3. Sterilize contaminated material
2. HOT AIR OVEN
An oven provides a temperature higher than that of atmosphere
The most common time – temperature relationships for sterilization
with hot air sterilizer are
170 0c for 30 minutes, 1600 c for 60 minutes and 150 0c for 150min
Sterilizing by dry heat is accomplished by conduction
Dry heat does most of the damage by oxidizing molecules . The
essential cell constituents are destroyed and the organism dies
Used for sterilize glassware, forceps, swabs, oils, waxes & powder
3. LAMINAR AIR FLOW
A laminar flow cabinet or laminar flow closet or tissue culture
hood is a carefully enclosed bench
A laminar flow hood consists of a filter pad, a fan and a HEPA
filter
Air is passed through a HEPA (High Efficiency Particulates Air)
filter which remove all airborne contamination to maintain
sterile conditions
Sterile air flows in to the working area where you can do all your
work without risk of contamination
4. VACUUM CLEANERS
The vacuum cleaner is the most used piece of electrical cleaning
equipment
The purpose of a vacuum cleaner is to collect all small piece of
litter and dust which embedded in the carpet
A vacuum cleaner is powered by a central motor which drives a
fan creating suction, the strength of suction is dependent on the
power of the motor.
They have a combination of filters which collect the dust and
prevent it from being recirculated in to the atmosphere
TYPES OF VACUUM CLEANER
1. UPRIGHT MODEL-These are used by pushing backward and forward
over the floor
2. BARREL STYLE-Usually on wheels with a flexible hose and have extension
tubes with a nozzle attached
3. CANISTER-Similar to barrel vacuum cleaner but they are cylindrical in
shape
4. WET VACUUM-Pick up water only
5. BACKPACK-The body of machine carried on the back
6. STICK VACUM-This is a small vacuum cleaner that is battery
operated
7. HAND HELD(DUSTETTE)-Similar to stick vacuum used in
emergencies for small spillage
5. FLOOR SCRUBBING MACHINES
A floor scrubbing machine is used for wet scrubbing on hard floors
They vary in sizes and the machine can be either manually operated or
automatic
A. Manual scrubbing machine-The floor to be mopped first with wet
cleaning solution and then scrubbed with the machine using a bristle
brush
B. Automatic scrubbing machine –Machine wets , scrubs and suction in
one pass
6. FLOOR POLISHING MACHINES
Polishing machines are used as the polishing of hard floors such as
vinyl, cork and marble
This are single disc machine used conjunction with brushes, floor
pads, floor strippers and polishes according to the task at the hand
These machines can be used to strip, polish and buff floors
The rotate between 150-650 rpm, high speed polishing machines -
2500 rpm
OTHER CLEANIG EQUIPMENTS
I. Out door sweeping machines
II. Trolleys
III. Buckets
IV. Mops
V. Rakes
VI. Broom and brushes
VII. Feather dusters
VIII. Squeeges
IX. Spray bottles
CLEANING BY CHEMICALS
Important points to choose a chemical
The cleaning tasks to be done
The types of surfaces to be cleaned
Consider the safety of using every chemical
The ability of the chemicals to do the job required
The smell of the chemical should be pleasant and fresh
Labelling of containers
Consider how the chemicals are dispensed and stored
1. ACIDS- soluble in water, pH level of less than 7
Rust remover oxalic acid
Hydrochloric acid-Remove very old stain
Phosphoric acid-Toilet bowl cleaners
Vinegar(Acetic acid)
2. ABRASIVES-Clean by scratching.
Available in paste , powder and liquid form
Used in heavily solid surface
3. DETERGENTS- They are usually slightly alkaline the remove soil acidic in
nature
4. ALKALIES-The pH level higher than 7.causatic and corrosive in nature
5. BLEACHES- Is not cleaner but does kill germs eg;sodium hypochlorite
6. DISINFECTANTS-The kill most bacteria with the exception of spores and
viruses so the called broad spectrum disinfectants.
Mixed with hot water increase the effectiveness.
Disinfectants need time to work and will need to be rinsed off surface
7. SANITISERS- Similar to disinfectants ,they do not need rinsed off and
used in food area
8. SOLVENTS- Solvents are contained within many detergents in small
quantities for general cleaning
White spirit-used for dry cleaning
Methylated spirit- Fastly drying agent in window cleaner
Acetone- Remove heavy stains such as grease , paint etc
SUMMARY
Cleaning validation plays an important role in prevention of
cross contamination in laboratory and industrial area
The main goal of cleaning validation is to verify the
effectiveness of cleaning procedure
Swab samples were collected from stainless steel surface of
production equipment and were evaluated by specific HPLC
analytical method for Anthracycline drug residual
determination to demonstrate the cleaning procedures
effectiveness
The analytical method is selective, precise , accurate, and
linear
REFERENCE
1. U.S Food and Drug Administration (1978)”Current Good
Manufacturing Practice for Finished Phamaceuticals ; Equipment
cleaning and maintenance.” Code of Federal Regulations
2. Matts Ramstorp” Introduction to Contamination Control and
Cleanroom Technology”
3. Health Products and Food Branch Inspectorate,Cleaning validation
guidelines,2008
4. Clean and maintain industrial work area and equipment,
D1.HHK.CL3.07 Trainee Manual