wfk - the cleaning technology...

wfk - The Cleaning Technology Institute wfk - The Cleaning Technology Institute

Dr. Manuel Heintz, wfk-Institut, Campus Fichtenhain 11, Krefeld, Germany,

[email protected], Tel. +49-2151-8210-190,

01. 04. 2014, NVK RABC seminar, Oslo

Founded 1949

wfk-Cleaning Technologie Institute e.V.

wfk-Institut für Angewandte Forschung GmbH

wfk-Testgewebe GmbH

Many members from different fields of

cleaning technology

App. 80 employees

The wfk-Institutes

The wfk-Institutes

Public funded research projects in the field of cleaning

technology

Textiles

Hard surfaces / building cleaning

Medical devices

Clean room

Industrial parts

Actually (February 2014) 23

different public funded research projects

are running at wfk-institute.

The wfk-Institutes

Services

Performance tests of washing and cleaning

agents, hygiene and disinfectant products

Provision of test materials for internal process

controls

„On-Site“-investigations e.g. in commercial

kitchens, facility cleaners, laundries, hospitals

Consulting (e.g. energy, prozess optimisation,

hygiene)

Certification of products and production plants (i.a.

laundries)

Dr. Manuel Heintz

1996 – 2002 Studies in Biology

2002 – 2006 Ph.D. in Microbiology

2006 – present wfk

Since 2011 Head of Department Applied

microbiology and hygiene at wfk-Services

Member in different working and standardisation

groups

Member in CEN-TC- 248 WG 17 and German

mirror group NA 106-01-12: Revision of EN 14065

2006 – 2014 ~ 400 hygiene investigations in

laundries

Hygiene in laundries?

Hygiene in the press

concerning to

Food

Hospitals

Kitchen

Farming of animals

Reprocessing of medical devices

Hands

Premature babys / children

Textile hygiene????????

Survival of pathogens on textiles

Partially survival > 30 days at hygiene relevant fungi 1

Many pathogens can survive several days, months,

partially years on textiles 2

Workers in laundries have more frequently antibodies

against Hepatitis A and B compared to normal

population 3

Spores can be transferred by textiles and causes

illness 4

1 Neely and Maley, 2001, Journal of Clinical Microbiology: Survival of some medically Important Fungi on Hospital Fabrics and Plastics

2 Kramer A, Schwebke I, Kampf G, 2006, BMC Infectious Diseases, How long do nosocomial pathogens persist on inanimate

surfaces? A systematic review

3 Untersuchungen zur gesundheitlichen Gefährdung von Arbeitnehmern in Wäschereien - unter besonderer Berücksichtigung der Belastung durch biologische

Arbeitsstoff, Schwerpunktaktion 2002, Freistaat Thüringen, Landesamt für Soziales und Familie, Abt. 2 – Landesamt für Arbeitsschutz und Arbeitsmedizin

4 Hosein et al. 2013. Journal of hospital infections. Summertime Bacillus cereus colonisation of hospital newborns traced to contaminated laundred linen.

Textile hygiene in health care sector

I.K. Hosein et al. / Journal of Hospital Infection 85 (2013) 149 – 154


I.K Hosein et al. / Journal of Hospital Infection 85 (2013) 149 – 154


I.K Hosein et al. / Journal of Hospital Infection 85 (2013) 149 – 154

The exact mechanisms of contamination of laundered linen with

B. cereus are in this publication unclear.

Possible explanations:

Growth of B. cereus in dirty used linen during storage

Water-efficient laundering processes can not remove germs /

spores completely

Solution of laundry in UK: Special linen was processed on

washer-extractors

Alternative solutions: Higher water usage in CBW or addition

of sporicidal agents did not yeald in adequate improvements

Hygiene in laundries

~ 1860 – 1987

Focus on disinfection of textiles

~ 1980s

First certification of „Hygiene in laundries“ appeared

2002

Publication of EN 14065

Beginning of EN 14065


BSE cases in Europe (mad cow disease)


Mad Cow Disease and the Decline of UK Beef

EN 14065

Textiles – Laundry processed textiles – Biocontamination control system

Biocontamination = contamination with viable microorganisms

DIN EN 14065 – RABC

The RABC system is published as European Standard

Its main purpose is the protection of consumers and end users!

It does not contain any microbiological limits

It is a quality management system with risk analysis

Only for biocontamination and hygiene

It is similar to the HACCP concept from which it was originated

The RABC system was scientifically evaluated

Advantages and disadvanteges of RABC

Advantages

European wide acceptance

(EN 14065)

Different European microbio-

logical limits can be covered

No textile care investigations

(especially meaningful for

leasing)

Adaptation to different

laundries and customer

requirements

Disadvantages RABC itself does not contain

any microbiological limits

More work because of self-

setted rules

Textile hygiene in IFS from version 5

3.2.2 Protective clothing for employees and visitors

3.2.2.5 All protective clothing should be cleaned

regularly and thoroghly. The clothing should be

cleaned according a process and product

orientated risk analysis by an external laundry,

on site or by the employees.

3.2.2.6 Defaults for cleaning and a procedure for

control of the cleanliness should be in place.

EN 13795

EN 13795 „Surgical drapes, gowns and clean air suits, used as medical

devices, for patients, clinical staff and equipment“

4 Requirements to manufacturing and reprocessing

4.1

Remark The application of a quality security system like EN 46001 and EN 46002, EN ISO 13485, EN ISO 13488, applied according to EN 724 and EN 14065, is recommended.

4.2 Validated processes should be used for manufacturing and reprocessing.

[...]

4.2.4 The relevant parameter of the manufacturing and reprocessing have to be determined, controlled and documented. The method and frequency have to be documented.

„Subject of EN 14065: Basics of

hygiene and microbiology"

Hygiene general

Hygiéia: greek god of health Definition: The toal of all procedures and behaviors for Prevention of Illness

Health maintenance of humans and

environment Hygiene means prevention and not therapy!

Aspects of microbiology

Parasitology (parasites)

Bacteriology (bacteria)

Mycology (fungi and yeasts)

Virology (viruses)

Proportion regarding size

The average size of bacteria is 0,2 - 5 µm

The baker‘s yeast is app. 8 µm

The diameter of viruses is 15 - 440 nm

Individual microorganisms are only visible via a

microscop!!

100 nm 1 µm 10 µm 100 µm 1 mm 1 cm 10 cm 1 m

Virus ~90 nm

Bacteria ~2 µm

cell ~10 µm

Paramecium ~200 µm Fungi ~ 10 cm

Human ~1,75 m

Classification in risk groups

Risk group 1: Biological material that causes

very unlikely disease

Bacillus subtilis

Risik group 2: Biological material that can cause disease but

the dissemination in population is unlikely; an effective

treatment is available

Salmonella Listeria monocytogenes Enterococcus faecium Staphylococcus epidermidis

Classification in risk groups

Risk group 3: Biological material that can

cause a serious disease, the dissemination in

the population can occur but an effective

treatment is available Mycobacterium tuberculosis

HIV (Gruppe 3**)

Risk group 4: Biological material that can

cause serious disease in humans, the risk for

dissemination in the population is high and a

treatment is not possible

Ebolavirus

Characteristics of microorganisms

Microorganisms are different in their

Habitats

Use of nutrients

Adaptation of environmental conditions (temperature,

pH, pressure, etc.)

Parasites

Endoparasites (e.g. worms)

Ektoparasites (e.g. lice or gnats)

A distinction is made between obligate and facultative parasites and fixed and temporary parasites

Some parasites are theirselves contaminated with monocellular parasites (protozoes) and transfer these on humans (e.g. mosquito and malaria)

The most parasites will be inactivated by chemothermal laundry procedures or treatments with 60 – 80°C.

Eukaryontes (cell nucleus, organells, cell membrane and cell wall)

Low requirements concerning nutrients

Growth at humid conditions

Survival at extrem conditions (e.g. pH, temperature)

High impact of mildews in food industry

Useful mildew and yeasts: e.g. producers of antibiotics, citric acid, baker‘s yeast for bread and beer

Fungi (mildew, dermatophytes and yeasts)

Damage through e.g.

Mycoses

Cell components (glucans)

spores (allergie causer)

metabolism products (toxins)

Inactivation:

• More difficult compared to bacteria through thick cell wall

• Possibe with antimycotics

• toxins can be intact after cell damage

Fungi and yeasts as pathogens

Fungi spores

budding

Proliferation of fungi and yeasts

Examples:

Aspergillus niger

Mildew

Present in food and ground

Risc group 1

Makes dark spores and mycotoxins

causes allergic reactions and lung aspergilloses

Temperature tolerance till 47 °C

High acid and alkaline tolerance

Is used for industrial production of citric acid

Characterisation of viruses

The are compost at least only of genetic information

and a surronding capsid

No growth, no splitting, no own metabolism

obligate parasites

Not suscetible to antibiotics

Susceptible to virustatics

High side effects!

Bacteriophages: relevant in food industry

Proliferation of viruses

No envelope

Causes vomiting and diarrhea

Extremly stable in environment

Low infection dosis: 10 – 100 virus particles

Patiants can be infectious 14 days before they get symptoms

Also aerogene transmission possible

But also contaminated surfaces or contaminated food is a common source for transmission

Norovirus

Characteristics of bacteria

Prokaryonts (no cell nucleus, no organells)

Growth by splitting

Fast proliferation possible

Adaptation to environment possible (mutation DNA)

Survival at extreme conditions

(e.g. pH, temperature)

Useful bacteria: production of vitamins and enzymes, food (e.g. yoghurt)

Gram-positive

Nearly all bacteria can be grouped according

staining behaviour of their cell wall:

Gram-negative

Gram-staining

Gram-staining

Gram-positive Gram-negative

Staphylococcus aureus

Gram-positive

Risk group 2

in the nose and throat regaion 25 – 30 % all humans have it inside, usually without having symptoms

Resistent against dryness and heat

MRSA

(Methicillin-resistenter Staphylococcus aureus)

Outbreak of disease usually at immun compromised patiants

Causes skin infections and muscles diseases, randomly also to lung infections, endocarditis, toxic shock syndrom (TSS) and sepsis

Each 70. patient on the intensive care section is infected with MRSA

Community aquired MRSA (cMRSA)

MRSA

(Methicillin-resistenter Staphylococcus aureus)

Percentage of non-susceptible S. aureus isolate

Very high resistance to

physical impacts

Can survive many thousands

years

Typical bacteria: Bacillus,

Clostridium

Spores

Clostridium difficile

Gram-positive, spore-former

Usual habitat is the gut

Risk group 2

Risk at: elderyl people

immuno compromised patients

Infection: with antibiotics natural enemies will be

killed C. difficile can proliferate and produces

toxins (toxine A water balance, toxine B destroying of

gut cells)

Caution: many antibiotics promote infection!

Formation at boundaries of watery

systems:

Solid-to-liquid: e.g. water contacted

machine parts

Solid-to-gaseous: e.g. storage tanks

Removal of biofilms only with mechanical

action possible

Biofilm

1. Adherence of single cells

2. Formation of extracellular polymeric substances

3. General growth

4. Stabile balance

5. separation of cells

Formation of biofilms

Pseudomonas aeruginosa

Gram-negative

Risk group 2

Partially many resistances against antibiotics

Produces toxins and makes hemolysis

Lung infections, infestation of implantats and catheters

Killing of microorganisms

Physical methods: heat, pressure, radiation, etc.

Chemical methods: disinfection agents, antibiotics

Humid heat: 20 min 121 °C

Dry heat: 30 min 180 °C

Laundry disinfection:

No laundry process for killing of spores present

Some sporicidal disinfectants available for killing

of spores

Killing of spores

Antimicrobial textiles: usage of silver

1. Implementation of silver ions in yarns

2. silver yarns

Release of positive charged ions

But: only little organic load will decrease antimicrobial effect

„Application of EN 14065 to

laundries"

EN 14065 –

The standard

Application area

This European Standard describes a risk management approach, called

Risk Analysis and Biocontamination Control (RABC), designed to enable

laundries to continuously assure the microbiological quality of laundry

processed textiles. The RABC approach applies for laundry market

sectors where it is necessary to control biocontamination, e.g.

pharmaceuticals, medical devices, food, healthcare and cosmetics.

Good working (laundering) practice (GLP)

Preparatory measures

R A B C

Examples for GLP

Collection of legislations

Determination of responsibilities

Building and technical-hygienical requirements

Hygiene requirements concerning employees

Hygiene requirements concerning textiles, materials,

treatment

Cleaning and disinfection plan

Pest control

Hygiene training for employees

Control of cleaning and disinfection measures


Management commitment

Constitution of the RABC team

The RABC team shall

Create a flow diagram of the laundering process

Analyse facility of the work environment

Determine the intended end use of the textiles

Set up of process specifications according to the type of

textiles and its intended end use

Purchasing information

Management shall take care of training and competency

Preparatory measures and implementation

Preparatory measure Implementation

Collection of legislations Print out and file

Determination of responsibilities Nomination of hygiene responnsible

person, RABC team, quality responsible

person

Building and technical-hygienical

requirements

List of hygiene relevant equipment and

machines

Hygiene requirements for employees Written provisions for employees to hand

hygiene, jewelerys, change frequency of

clothing, hair dress, etc

Hygiene requirements for textiles, materials

and treatment

Written determinations to

- Suppliers and product specifications

- Textile quality

- Waste disposal

- Canteen, food distribution

- etc.

Preparatory measure Implementation

Cleaning and disinfection plan Establishment of cleaning and disinfection

plan, proof if stocks, machines and

procedures are sufficient

Pest control Commission of an external pest control

company (requirements concerning

documentation: ooverview plan,

qualification certificate, list of used toxic

substances)

Hygiene training for employees Recommendation: at least yearly or

explanation why not yearly trainings

Control of cleaning and disinfection

measures

Formulas for signing if cleaning and

disinfection measures are done

Preparatory measures and implementation

RABC team

Team can be more effective than one person alone

It should be multidisciplinary to have different views on hygiene

issues

Representative of each department of the laundry

Representative of the hygiene/cleaning team

Quality representative

A qualified microbiologist

External recources may be deployed to ensure sufficient

expertise.

Definitions: hazard and risk

Hazard + Risk

Definitions: Risk analysis

Investigation of available information to identify hazards and to estimate

the consequential risks

Definitions: Control points

Any point or process step at which control is applied in order to eliminate

or reduce biocontamination risk

Any point or process step at which active control on the

biocontamination for the textiles can be applied

(= reduction of biocontamination on textiles)

Definitions: levels

„Must have“ level (loss of control level)

Action level

Alert level

Target level

level

Measurements/Monitoring

measurements

Definitions: levels

Guaranteed hygienic quality

Action level

Alert level

Target level

mic

robio

logic

al/ h

ygie

nic

level

Measurements/Monitoring

measurements

Definitions: Corrections

Corrective action

Are needed to get control again over a process after measurements have

exceeded alert or action levels

Monitoring program

Identification of the parameters to be monitored at the control points,

together with the frequency of observation

Good working (laundering) practice (GLP)


R A B C

7 principles of the RABC system

1. List of microbiological hazards and list of control measures

2. Determination of Control Points (CP)

3. Establishment of target levels and tolerance limits for each

Control Point

4. Establishment of a monitoring system for each Control Point

5. Establishment of corrective actions

6. Establishment of the RABC system checking procedures

7. Establishment of a documentation system

List of microbiolocial hazards and list of control measures

Should be combined with flow diagram

Task of RABC team

Classification of risk: low, medium, high and very high risk

1. Principle

Quantitative risk analysis

Assessment of risk for each hazard

P = Probability of occurance for the hazard

S = Severity of the consequences where the hazard

occurs

Quantitative rating scale, e.g. 1-10

Resulting in values from 1 - 100

The lower the value the lower the risk for

biocontamination

2. Principle

Determination of Control Points

The moist important CP is the washing process

Another CP could be the drying process

Importance of washing process:

1. Single process which removes

microorganisms from textiles

2. Single disinfection process for textiles

3. Single disinfection process which sucess

can be surveyed with bioindicators

Establishment of target levels and tolerance limits for each

Control Point

All relevant parameters must be considered

Example: thermal disinfection with 10 min at 90°C, target

for temperature: 92°C with a tolerance of - 1°C, target for

time: 12 min with a tolerance of – 1 min.

3. Principle

4. Principle

Establishment of a monitoring system for each Control Point

How often the performance of the washing process will

be analysed (disinfection performance, cleaning

performance?)

How often different parameters will be investigated

Alarm signals if temperature not reached or detergents

not dosed

5. Principle

Establishment of corrective actions

Should be done together with risk analysis

Prevention: corrective actions will be setted up before

problems arise

6. Principle

Establishment of the RABC system checking procedures

Validation and revalidation of the washing process (CP)

Review of the RABC system by the RABC team

Internal audits by the management

Usually microbiological investigation once a year

7. Principle

Establishment of a documentation system

Depending of the size and organisation of the laundry

Depending of complexity and interaction of processes

Depending of competence of personnel

„Hazard analysis"

Dr. Manuel Heintz

01. 04. 2014

NVK seminar, Oslo

Hazard analysis

Is very common

in engineering

in business and financing

in health care

in sociology, decision theory, philosophy

….

We all do risk analysis many times a day

Risk analysis

List of microbiolocial hazards and list of control measures

Should be combined with flow diagram

Task of RABC team

Classification of risk: low, medium, high and very high risk

1. Principle


Assessment of risk for each hazard

P = Probability of occurance for the hazard

S = Severity of the consequences where the hazard

occurs

Quantitative rating scale, e.g. 1-10

Resulting in values from 1 - 100

The lower the value the lower the risk for

biocontamination


P =

S =

R =

Impressions from laundries

P =

S =

R =

Customer claim

Arising claims from customers from the food sector:

Foreign body management concerning

glass

Jewellery

flies

needles

Wood

…

The RABC and risk analysis can be used to

cover this claims

Example: needle management

Hazard: (broken) needles in textiles

Cause: Forgotten or broken needles

Risk: from experience deducible (How often break needles? How

often are complaints from customers concerning needles in textiles?

How often needles or needle parts will be found in textiles

internally?)

Control measures: sensitization of employees, list of complaints, list

of forein bodies in textiles found internally, distribute only numbered

needles and collect them completely, occasionally analyse textiles

concerning needles (or parts) with a metal detector

Example: Fly management

Hazard: Flies in textiles

Cause: Flies in laundry

Risk: from experience deducible (How often are complaints from

customers concerning flies in textiles? How often flies or fly parts will

be found in textiles internally?)

Control measures: sensitization of employees , occasionally analyse

textiles concerning flies or fly parts, do not forget documentation

„(Critical) Control points and

validation"

What is that?

End product versus process controls

Machine

Rescources

Process controls End product controls

End product versus process controls

Process controls

Performed at each process

Guarantee the right function of the process

End product controls

Statistical based sampling and measuring of end

products

2. Principle

Determination of Control Points

The moist important CP is the washing process

Another CP could be the drying process

Importance of washing process:

1. Single process which removes


2. Single disinfection process for textiles

3. Single disinfection process which sucess

can be surveyed with bioindicators

Establishment of target levels and tolerance limits for each

Control Point

All relevant parameters must be considered

Example: thermal disinfection with 10 min at 90°C, target

for temperature: 92°C with a tolerance of - 1°C, target for

time: 12 min with a tolerance of – 1 min.

3. Principle

4. Principle

Establishment of a monitoring system for each Control Point

How often the performance of the washing process will

be analysed (disinfection performance, cleaning

performance?)

How often different parameters will be investigated

Alarm signals if temperature not reached or detergents

not dosed

Validation

What means process validation???

? ? ? ? ? ? ? ?

- a process matches in its performance the redetermined specifications and this performance in fact generates - the limit values (target levels) of the process parameters are determined so that without testing the textiles the products can be released

The validation of processes ensures that

Validation

Validation = documented evidence that a process fulfills the

predetermined requirements (acceptance criteria)

reproducible in routine applications.

Importance of washing process

Single process in laundry which removes


Single disinfection process for textiles in laundry

Single disinfection process which sucess can be

surveyed with bioindicators

Validation

1. A process matches in its performance the

redetermined specifications and this performance in fact generates

Which performance (from hygienic point of view) should a washing process achieve?

Germ reduction by > 7 log10 units (for specific test germs)

Validation

2. the limit values (target levels) of the process parameters are determined so that without testing the textiles the products can be released

Process parameters: temperature time chemistry liquor ratio amount of load washing specification (alkalinity, pH-value, aktive oxygen,

conductance, etc.)

Set / Actual-values

Set values = Requirements to process parameters

Actual values = measured values for process parameters

Important: set values are always values for Soll-Werte sind immer Vorgaben für die tatsächlich in der Flotte erreichten Parameter

Process parameter: temperature/time

Requirements example 1:

According to manufacturers information or special lists (e.g.RKI list): 10 min 70°C in main wash

Requirement example 2:

15 min 55°C in prewash

and

10 min 70°C in main wash

Process parameter: chemistry

Requirement to dosing pumps that

corresponding amount of chemistry really will

be dosed in machines

Specification in dosing performance per second

(ml/s)

or better

dosing amount (measurement directly at

machines)

Process parameter:

liquor ratio / load amount

Washer extractor: Determination of amount of water via display at

machines and mark of water level at window in machines

CBW: determination of water level via connecting tubes

Documentation of load amount, function control of balance

Parameter of titration

Specific informationaccording to washing agent and wash procedure. Set-values and actual measurements for

Alkalinity

pH-value

Aktive oxygen

conductivity

etc.

Recordings in management systems

Definition „recording“

• Document that shows achieved results or

provides an evidence of executed actions

• Remark 1 Recordings can be used for declaration of

traceability, as proof for verification, prevention and

corective actions

• Remark 2 Recording do not require supervision of

revision.

Signatures

All recordings associated with CP monitoring shall be

signed authorised by the person(s) performing the

monitoring operations and by the designated person(s)

responsible for interpreting the results.

[EN 14065, chapter 6.2.4]

Research project

Development of safely disinfecting finish processes (IGF

14673 N)

Run time: 2006 – 2008

Aim: Development of disinfecting finish processes which can

be validated and are reproducible

Textile temperature

40

50

60

70

80

90

100

110

Te

mp

era

ture

in

°C

(A

ve

rag

e v

alu

e o

ve

r 5

min

)

0 bar (Hot air) 1,5 bar steam pressure 3,5 bar steam pressure

Sleeve right

Sleeve left

up right

up left

middle right

middle left

down right

down left behind

Textile temperature during finishing (34% rest humidity,

saturated steam temperature 140 °C)

Germ reduction by Finishing

2

3

4

5

6

7

8

9

10

behind Sleeve

left

sleeve

right

left right pocket

left

pocket

right

down left down

right

Ge

rm r

ed

uc

tio

n [

log

10

un

its

]

unfavorable finishing conditions favorable finishing conditions


High consitant reduction rates possible but only with conditions

favoring textile damage

Not as consistant as washing procedures

No removal of parts of microorganisms

Washing procedure most important step for

reduction of microorganisms

„Practical approach for

implementation"

How to start with EN 14065?

You have already started!

How to start with EN 14065?

Found a RABC team!

Check the prerequisites!

Check the requirements!

Do the risk analysis!

Take the first microbiological samples

Possibly use external help for setting up the

documentation, validation of washing process and/or

microbiological sampling.

How to live EN 14065?

Yearly managment reviews: internal audits, certification

Internal meetings of RABC team

At least yearly microbiological investigations: validation of

CP, environmental monitoring and end product controls

Quarterly, monthly, weekly or daily: internal plant

controls, control of process parameters

Probably Quarterly: internal microbiological investigations

PDCA-Cycle

Improvement

Time

Desinfection

Definition:

„to transfer an area or an item in a condition so

that no infection risk can arise from them"

From cleaning to hygiene

CFU

Cleaning Disinfection Hygiene

Time

Disinfection agents

Contact time concentration Contact temperature No protection agents present Application procedure Agent combination Proteine failure Soap failure pH-value Stability

Disinfection are only effective if

are correct!!!

Spectrum of disinfectants

Hygiene- and disinfection controls

Useful controls:

Contact samples of textiles (wet and dry), surfaces, personell

Investigation of water (municipal, well, rinsing and softened water)

Disinfection efficacy of washing processes with bioindicators

Microorganisms on/in humans

1 bill./cm2

100.000 – 1 mill./cm2

1.000 – 10.000/cm2

100 bill./g

20 – 100/cm2

10 - 100/g

Wasching of hands and

disinfection of hands

Only disinfection Washing of hands +

Disinfection of hands

Ø = 35 CFU/dm2 Ø = 536 CFU/dm2

129 Hepatitis A-Infection

Weeks after infection

Re

lative

co

nce

ntr

atio

n

Contact samples

Use complete surface of

agar

Avoid contamination

Open agar shortly

before usage

Label back side

Water investigation

Let enough water run out to avoid sampling stand water

Afterwards heat tap

Open tap to produce equal jet

During sampling do not change tap setting

Open sampling vessel shortly before usage

Cood down water sample or start analysis

Microbiological investigation

of washing processes

S. aureus

E. faecium

According VAH-/RKI-method

> 7 log10-reduction requirement according VAH

Bioindicators for container disinfection

Standards:

DIN 58955-4 „Decontamination equipment

for medical use - Part 4: Biological

indicators“

AK-BWA „Working group reprocessing of

bed racks“

Reduktions-

faktor von mind. 5 log10-Einheiten

Bioindicators for testing the disinfection efficacy of

container disinfection

> 5 log10-reduction requirement according standards

Microbiological limits

Alert/ action level Limit

Disinfection efficacy

washing process

> 7 log10 units > 7 log10 units

Dry textiles 0 - 10 CFU/dm2

(health care)

20 CFU/dm2 (health

care)

Wet textiles 0 – 15 CFU/dm2

(health care)

30 CFU/dm2 (health

care)

Surfaces 100 CFU/dm2 100 CFU/dm2

Personell 100 CFU/dm2 100 CFU/dm2

Disinfection efficacy

container disinfection

> 5 log10 units > 5 log10 units

0

50

100

150

200

250

Q1,FW

Q1,TW

Q1,O

Q1,P

Q2,FW

Q2,TW

Q2,O

Q2,P

Q3,FW

Q3,TW

Q3,O

Q3,P

Q4,FW

Q4,TW

Q4,O

Q4,P

Mit

telw

ert

KB

E/d

m2

Analysis of microbiological data

1 (4)

1 (2)

2 (13)

5 (10)

Wet: 1 von 11 (9,1%)

Dry: 1 von 22 (4,5%)

Surf.: 1 von 23 (4,3%)

Pers: 14 von 43 (32,6%)

1 (4)

4 (10)

3 (10)

W D S P W D S P W D S P W D S P

Av

era

ge

va

lue

CF

U/d

m2

Impressiones from laundries

Revision of EN 14065

Control Point (CP) will be named Critical Control Point

(CCP)

Old CP will be defined as places were sampling will be

performed (named as CPs)

Risk analysis should be performed quantitatively

Validation of CCPs will be more important

Validation discussion at

revision of EN 14065

Worst-Case-Szenario: Determination of the performance with worsening process parameters or higher organic load Statical experimental design All independent process parameters will be modified according to a statistical based plan

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