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THE BACTERIAL BARRIER FOR HUMAN PROTECTION

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Hong Kong 2016

Sterile Packaging Process

& Packaging materials

THE BACTERIAL BARRIER FOR HUMAN PROTECTION 2

Your speaker today : Dr. David DUWELTZ

� Technical Support & Regulatory Affairs Manager

� ArjoWiggins Healthcare

�A large range of sterilization wrap from standard creped paper to non-woven

�A large range of standard or reinforced paper for sterile packaging

� Arjowiggins participation

�Standardization expert for sterilization packaging

- AFNOR SR95 GT1

- CEN TC102 WG4

- ISO TC 198 WG7

� “Sterile Barrier Association” technical committee

�WFHSS industrial partner

THE BACTERIAL BARRIER FOR HUMAN PROTECTION3

Wraps : Standard or Reinforced papers

Textile Wet laid non woven SMS (PP)

Metallic containersSingle use filter

Reusable filter

Paper based pouches

PeHD based pouchesSelf seal pouche

Heat seal pouche

Packaging System



Quick overview on

Regulations & Standard

for packaging

in European Community


European Community key regulations

� Directive 93/42/EC

� CSSD wraps, pouches, containers are classified as single use class I

medical device

� Class I MD = Self declaration, no Notified Body required

� Mandatory compliance on M.D.D. essentials requirements

� Operations under certified quality management systems (ISO9001/ISO13485)

� Production under a completed risk analysis (ISO14971 – Ann. C) &

implemented risk management system

� Manufacturing with a full process & raw materials trace ability

� Self declaration to official authorities depending from MoH

� Products marketed with CE mark labeling (EN980) & available I.F.U.

� Use of harmonized norms for products definition, validation & production


2 KEY STANDARDS

ISO 11607

-1 & -2

EN 868

series


ISO 11607 standards

� Harmonized norms referential, acting as EC specifications

� Transversal packaging concepts standard

�EN ISO 11607-1:2009 “Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems & packaging systems”

�EN ISO 11607-2:2006 “Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes”

�Gathering extensively & on a worldwide consensus, all the mandatory major requirements to comply with for any kind of M.D. packaging

�Applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.


� ISO 11607 – Sterile Packaging Definitions

� Medical Device placed in packaging material- Closed, Sterilized, Distributed, Stored, Aseptically opened

� Sterile Barrier System (SBS) - Minimum package that prevents ingress of micro-organisms & allows aseptic

presentation of the product at the point of use

� Protective packaging- Configuration of materials designed to prevent damage to the sterile barrier system &

its content from their time of assembly to the point of use

� Packaging system:- Combination of the Sterile Barrier System & Protective Packaging

European Community key standards


� Packaging system = SBS (Sterile Barrier System)

+ Protective packaging

� Aseptic opening + barrier

� Recommendation : SBS should be made of 2 layers

� Packaging system should consist in a SBS and

a protective packaging: 2 possible answers:

� SBS made of 2 layers, outer layer playing a double part:

� Barrier & Protection

� SBS made of 2 layers + 1 layer for protective packaging

or other transport solution (e.g. Tray)

=> Packaging system is made of 3 layers



EN 868 standards

� Harmonized norms referential, acting as EC specifications

� Vertical packaging products dedicated standards

�EN 868:2009 series: “Packaging for terminally sterilized medical devices –Requirements & tests methods”

- Part 2: Sterilization wraps (Papers / NW / Textile)- Part 3: Paper for use for paper bags (specified in EN 868-4) and for pouches

and reels (specified in EN 868-5)

- Part 4: Paper bags

- Part 5: Sealable pouches and reels of porous and plastic film construction

- Part 6: Paper for low temperature sterilization processes

- Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN285

- …


Sterilization packaging : EN 868-2 in detail

� Specific requirement for material used for wrapping material


General aspectColour leaching ISO 6588-2 1.1Toxic substancesSubstance EN ISO 536 1.2

pH of aqueous extract ISO 6588-2 1.3Chloride Content ISO 9197 1.4Sulphate Content ISO 9198 1.5Fluorescence Annex B 1.6Drapability 1.7Alcohol repellency EN 868-2.A 1999 Surface resistivity BS 6524

4.1 4.2.4.6 not required if packaging only designed for irradiation sterilization

4.2 Refer to ISO 11607-1 for nb of treatment cylces

Stretch MD EN ISO 1924-2 2.2 > 10 % 3.4 > 5 %Stretch CD EN ISO 1924-2 2.2 > 2 % 3.4 > 7 %Tearing strength MD EN 21974 1.1 > 500 mN 3.1 > 750 mN EN 13937-1 4.4 6 N

Tearing strength CD EN 21974 1.1 > 500 mN 3.1 > 1000 mN EN 13937-1 4.4 6 N

Air permeance ISO 5636-3 1.2 > 1,7 µm/Pa.s ISO 9237 4.6 < 20 mm/s*

Dry burst strength EN ISO 2758 1.3 > 110 kPa 3.2 > 130 kPa EN 13938-1 4.5 > 100 kPa

Wet burst strength ISO 3689 1.4 > 35 kPa 3.3 > 90 kPa EN 13938-1 4.5 > 100 kPa

1.5 >20s1.5 >30s1.6 < 50 µm (ind values) 2.4 < 50 µm (ind values) 1.6 =< 35 µm (Avg of 10

values)2.4 =< 35 µm (Avg of 10

values)Drape MD EN 868-2D <160 mm <125 mmDrape CD EN 868-2D <125 mm <160 mmMason Jar EN 868-2E > 75 minAir permeance EN 868-2F > 10 l/min/100cm²Drape Cuisick Test ISO 9073-9 < 85 %Hydrostatic test EN 20811 3.5 no requirement before new

version of control standardISO 20811 4.7 no requirement before

new version of control standardTensile strength MD EN ISO 1924-2 1.7 > 1.33 kN/m 2.5 > 1.33 kN/m 3.6 > 1.00 kN/m EN 29073-3 4.3 300 N

Tensile strength CD EN ISO 1924-2 1.7 > 0.67 kN/m 2.5 > 0.67 kN/m 3.6 > 0.65 kN/m EN 29073-3 4.3 300 N

Wet tensile strength MD ISO 3781 1.8 > 0.33 kN/m 2.6 > 0.33 kN/m 3.7 > 0.75 kN/mWet tensile strength CD ISO 3781 1.8 > 0.27 kN/m 2.6 > 0.27 kN/m 3.7 > 0.50 kN/mCobb sizing (60s - 2 sides) EN 20535 1.9 < 20 g/m²

Water resistance Annex D 2.3 > 20 s

2.1 Creped to give increased flexibility

Miscellaneous

Pore size Annex E

+/- 5 % of nominal value

5 < pH > 8 < 0,05 % < 0,25 %

on request with appropriate method

Plain paper

Characteristic

Free from tears, creases, localised thickening

Crepe paper Non vowen

No color leaching

Linen

* not required if packaging sterilized by irradiation method (4.1)

General requirementsMethod EN 868-2: 2009 values

No substance know to be toxic shall leachin sufficient quantity

> 7 (for sterile field only)< 1x1013 ohms

max 1% increase of optical brightener or 5 spots greater than 1mm


EN 868 standards and sterile field

Intended use Associated standard

Sterile Barrier

System

Sterile

Field

ISO 11607

& EN 868-2

EN 13795

Sterile wrap used as sterile field must conform to ISO 11607 & EN 868-2 & EN 13795


EN 13795 Surgical drapes, gowns & clean air suits

Characteristic Standard Unit

Standard performance High performance

Critical areaLess critical

areaCritical area

Less critical

area

Resistance to microbial penetration

- DryEN ISO 22612

Log10

(CFU)N/A ≤ 2 N/A ≤ 2

Resistance to microbial penetration

- WetEN ISO 22610 BI ≥ 2,8 N/A 6 N/A

Cleanliness - microbial

(Biocharge / bioburden)EN 1174

Log10

(CFU/dm²)< 2 < 2 < 2 < 2

Cleanliness - particulate matter

ISO 9073-10

IPM < 3,5 < 3,5 < 3,5 < 3,5

LintingLog10

(lint count)< 4 < 4 < 4 < 4

Resistance to liquid penetration EN 20811 cm H2O ≥ 30 ≥ 10 ≥ 100 ≥ 10

Bursting strength DryEN 13938

kPa ≥ 40 ≥ 40 ≥ 40 ≥ 40

Bursting strength Wet kPa ≥ 40 N/A ≥ 40 N/A

Tensile Strength - DryEN 29073-3

N ≥ 15 ≥ 15 ≥ 20 ≥ 20

Tensile Strength - Wet N ≥ 15 N/A ≥ 20 N/A


� Wraps material� Woven, textile (Linen)

� Paper (crepe/soft crepe/reinforced)

� Non-Woven (Cellulose based non-woven

or SMS)

Linen

Wet Laid Non Woven

Reinforced Soft Crepe Paper

Standard & Soft Crepe Paper

SMS

EN 868 standards


� Woven, Linen, Textile

� Blends of cotton and synthetic materials (PET)

� Newly listed in EN 868-2 / Specific requirements

� Barrier quality of textiles is represented

in "thread counts" per square inch

� Minimum acceptable thread count for surgical textiles

is 140 threads/inch

� Higher thread count, greater resistance to dust penetration

� Treated with chemical to increase moisture resistance

EN 868 standards


Standard and Soft Crepe Paper

100% wood pulp materialOriginal wrapping material and the most cost effective

Reinforced Crepe Paper

80% wood pulp20% synthetic surface bindersBetter drapeability, softness with higher strength

� Crepe paper

EN 868 standards


Wet Laid Non Woven50% Wood pulp 30% Synthetic fibers20% Synthetic bindersHigher fluid repellence, drapeability and strength

1818

� Non Woven

EN 868 standards

SMS (Dry Laid Non Woven)Spunbond /Meltblown / Spunbond100% synthetics fibers PolypropyleneThe material with the highest mechanical resistance


Medical Device Directive (MDD 93/42/EEC) amended 2007Essential requirements for selling on CE market (CE marking )

DIN 58953-6

ISO 10993

EN 11737

ASTM F2101ISO 5646-3

ISO 536

93/42/EEC directive for medical devices

ISO 11607

EN 868-2

…….ISO 1924-2 …..

ISO 9001

ISO 13485

Risk

analysis


21

MATERIAL

SAFETY

MICROBIAL

BARRIER

STERILIZATION

COMPATIBILITY

MECHANICAL

RESISTANCE

ASEPTIC OPENING

SHELF LIFE

LIMITATIONS

CLOSURE SYSTEM

ISO 11607-1 : key properties


� Some basic principles about its design in order to understand both its

functionalities & related requirements

� Non-compliant materials are the ones which are not barrier enough to stop bacteria on their way

� Materials with holes or with insufficient tortuous path

Micro-organismsSterilizing agent

175 µm

Packaging principles



STERILIZATION

COMPATIBILITY

� Different sterilization processes

� Steam

� Formaldehyde (LTFS)

� EtO

� Irradiation

� Vaporized Hydrogene Peroxyde

(Plasma)

� Compatibility need to be considered


Packaging Material STEAM DRY HEAT EtO LTFS Plasma

wrap Cellulosic crepe

paper� �* � � NO

Wet laid non-woven � �* � � NO

SMS (100% PP) � � � � �

Linen � � NO* NO* NO

pouches Cellulosic paper � �* � � NO

Tyvek (PEHD) NO* NO* � � �

container depending on the type of filter

Sterilization Compatibility


� 3 Key properties to consider

�Efficiency of the sterilization process

- Sterilizing agent penetration testing

�Conservation of physical & chemical performances after

sterilization

- Mechanical test / Material composition follow-up

- Resistance to the stress of the sterilization on the closure system

�Efficiency of air/sterilizing agent removal

- Presence of sterilizing agent residues (EtO / FO)

- Wet pack with Steam sterilization



� Sterilizing agent penetration � For steam sterilization material should be porous

� Test performed : Air permeance (Bendtsen porosity) for paper

» This test determines the volume of air that will flow through a 10

cm² area of test material in 1 minute under a pressure gradient of

1.47 kPa

» Determination of the “porosity” of a material

» For Paper for steam pouches (EN 868-3)

» Porosity > 300mL/min



� Sterilizing agent penetration � For steam sterilization material should be porous

� Test performed : Air permeance (Bendtsen porosity) for paper

� Test performed : “High porosity test” for NW


Crepe paper Cellulose

based NW

SMS

Substance g/m² 60 60 50

Porosity (bendsten)(tested on 4 layers)

mL/min 2000 >>3500 >>3500

High porosity(tested on 1 layer)

l/mn/100cm² <<8 20 200


�Efficiency of air / sterilizing agent removal�One example : wet packs

- High load mass = large amount of condensate

- Inhibition water vapor removal during the drying stage

» Excess layers or folds of packaging materials

» Low porosity packaging materials

» Synthetic, non-wetable barrier materials




MICROBIAL

BARRIER

� Material acting as a microbial filter

� porous to the gaseous sterilizing

agent

� Preventing ingress of micro-

organisms


� Material acting as a microbial filter, being porous to the gaseous sterilizing

agent and preventing external pack ingress of micro-organisms coming

from:

� Air (airborne dust,

micro-particles, …)

� Fluids ( droplets, aerosols, …)

Microbial Barrier


� Maximum Pore size for crepe paper (EN 868:2009 Part 2 Annex E)

� Acceptance criteria < 35 µm (average)

� Individual value < 50 µm

How to characterize this Tortuous Path ?


� One example: the BFE (bacterial filtration efficiency) testing

A calibrated suspension of golden staphylococcus is dried & then

sprayed onto the sample, while an airflow is maintain at constant

flow rate, in order to force the aerosol thru the material to be

evaluated

The number of microorganisms going thru the tested sample is then

evaluated via culture on a nutritive media placed on the over side,

the final result being expressed as the percentage of

microorganisms stopped by the material

Result given as a percentage

Higher the value, better is the filtration

Microbial Barrier


Bacteria

Sample

Agar medium

AIR FLOWPOWDER

MATERIAL PAPER or LINEN

� One example: the Germ Proofness DIN 58953-6 test

§ 2.15 Dry challenge test

Simulates exposure to airborne bacteria by placing a microorganisms powder in contact of a pressurized /

depressurized sample. Then are counted the microorganisms passing trough the sample on a nutrient

medium placed on the opposite side

Pass or Failed Test

Microbial Barrier


Bacteria

Sample

Agar medium

DROPLETS

MATERIAL PAPER or LINEN

� One example: the Germ Proofness DIN 58953-6 test

§ 2.14 Wet challenge test

Simulates exposure to liquid-borne bacteria by placing few microorganisms aqueous droplets in contact of a

sample. After drying & incubation are counted the microorganisms passing trough the sample on a nutrient

medium placed on the opposite side

Pass or Failed Test

Microbial Barrier


� Mason Jar� For Non Woven material (EN 868-2)

� Description of Mason Jar test :

A circular test piece is placed in the cap of the Mason

Jar, containing 510 ml of deionised water, between a

Teflon gasket and a rubber gasket. The jar is then

turned upside down and the top of the jar is removed

so that the weight of the solution bears down on the

sample. The time required for the liquid to penetrate

the test piece is measured by determining the end

point while viewing the sample through a glass plate.

The result is given in minutes. Minimum required by

EN 868-2 is 75 minutes.

� Removed from the new version

� A much more representative of normal conditions of

use => ARJOWIGGINS Healthcare still relies on it to

test their Sterile Barrier Systems

Microbial Barrier


� Hydrostatic Test� For Non Woven material (EN 868-2)

� Description of Hydrostatic test :

A sample is clamped onto the bottom of a vertical column,

into which water in poured. Then water pressure is increased

at the rate of 10cm/min. When leakage is observed on

the underside of the fabric, the height of water in

the column is registered in centimeters..

� Replace Mason Jar Test

� BUT NO REQUIREMENT for the moment !!

� Test coming from standards on textile fabrics

� Not very representative of what happen to a sterile pack, that is more likely to suffer from

humidity than from water under pressure

� Minimum requirement exist in EN 13795 (draps and gowns)

Microbial Barrier


MECHANICAL

RESISTANCE

37


� Material should be resistant to :

� Handling

� Transportation

� Storage conditions

� Sterilization process


MECHANICAL RESISTANCE

� Minimum requirements in EN 868-2

Properties/Papers STANDARDS UnitsEN 868 Part 2

Creped Paper

EN 868 Part 2

Non Woven

Substance ISO 536 g/m² +/- 5% +/- 5%

Tearing strength MD EN 21974 mN > 750

Tearing strength CD EN 21974 mN > 1000

Dry burst strength ISO 2758 kPa > 130

Wet burst strength ISO 3689 kPa > 90

Tensile strength MD ISO 1924-2 kN/m > 1.33 > 1

Tensile strength CD ISO 1924-2 kN/m > 0.67 > 0.65

Wet tensile strength MD ISO 3781 kN/m > 0.33 > 0.75

Wet tensile strength CD ISO 3781 kN/m > 0.27 > 0.5

Stretch MD ISO 1924-2 % > 10 > 5

Stretch CD ISO 1924-2 % > 2 > 7


� Conservation of physical performance before and after

sterilization�Comparison of the mechanical properties before and after sterilization

- Burst strength (Dry & wet)

» ISO 3689

» ISO 2758

- Initiated tear resistance

» ISO 1974

- Tensile strength (Dry & wet)

» ISO 3781

» ISO 1924.2



MECHANICAL RESISTANCE : BURST STRENGTH


MECHANICAL RESISTANCE : TEAR STRENGTH


MECHANICAL RESISTANCE : TENSILE STRENGTH


� MACHINE & CROSS direction (MD & CD)

�Wrap material is usually anisotropic

� Performance depends on the direction of the material


CROSS DIRECTION

MA

CH

INE

DIR

EC

TIO

N

Performance

CD > MD



ASEPTIC OPENING

CLOSURE SYSTEM

DESIGN

QUALIFICATION


� Wrapping Techniques� Several wrapping methods

� Envelope folding

� Square folding (parcel)

� Pasteur folding

� Roll method

� The most common and recommended folding is envelope folding & square folding

� Create the more tortuous path which means a better barrier against penetration of micro-organism

� Envelope folding

� Reduce handling during opening thanks to the tab

� Design used for Event-Related Sterility Maintenance Study

Packaging Design


� Wrapping Techniques� Envelope folding

� Square folding or parcel fold

Packaging Design


� Wrapping Techniques� Double sequential wrap is recommended

Packaging Design


� Wrapping Techniques� Double sequential wrap is recommended

� Bacterial filtration efficiency & germproof ness test improved

� Guarantee aseptic opening

� Possibility to combine different generation wraps and offer a combination of the best characteristics and benefits of each generation of products

� Possibility to have a color coding

� Security : Superposition of two colors allows to visualize any defect & prevent dust cover entering the operation rooms

Packaging Design


SHELF LIFE

LIMITATIONS

4949


� Before sterilization

� Storage condition

� Expiration date ?

� After sterilization

� Sterility maintenance


Shelf life limitations

� Expiration date

� Expiration date for wrap material is usually 5 years

� Based on follow up of the properties after natural ageing

� Storage conditions

� IFU� Storage away from excessive light or UV radiation

� Keeping the material in its original packaging

� Storage in clean, ventilated and dry conditions, off the floor

� temperature (10°C - 40°C), HR (30% to 60%)



� Sterility Maintenance Evaluation

� It is commonly accepted that

Shelf-life of a packaged sterile item is event-related

� Shelf-life depends on :

� the quality of the wrapper material

� the storage conditions

� the conditions during transport

� the amount of handling

� How to be sure that’s the DM is still sterile?



� Producer’s technical documentation

�One example: the Event Related Sterility Maintenance Study / wrap

- This test is performed on sequential double-layer packaging after sterilization, and

simulates shelf storage of sterilized packs facing « normal life » events.

- The test protocol includes :

» Control of the sterilization efficacy

» One post sterilization handling & transfer to the storage area made of open shelves (no

dust cover added)

» A weekly manual checking simulating an inventory.

» Environmental bio-burden & the storage conditions (°C / %RH) are monitored.

» Bacteriologic expertise of inside located gauzes after 180 days

» Results expressed in % of non contaminated sites after a given period of time




� Producer’s technical documentation

�One example: the Event Related Sterility Maintenance Study / wrap

Packaging principles

Wraps

Sterility Maintenance

(30 days / 180 days)

Uncontaminated gauzes

Sterisheet Creped Paper 100 % / 100%

Sterisheet Reinforced Creped Paper 100 % / 100%

Sterisheet Wet Laid Non Woven 100 % / 100%

Sterisheet SMS100 % / 100%


54

MATERIAL

SAFETY


� Known and traceable materials

� Material composition control

without leaching

� Non toxic

� Biocompatible

� Acceptable bioburden


� Biocompatibility & toxicological attributes evaluation

� One example: the cyto-toxicity testing

� Material extracts (25 hours @ 37°C) are

placed in contact with mouse fibroblastic cells L929 during 48 hours @ 37°C

� Material is rated from 0 to 4 according to observed increased percentage of

destroyed cells comparatively to 2 masters (a positive one: natural rubber extract,

a negative one: PP extract)

�US pharmacopeias considers a material as cyto-toxic if rating more than 2,

meaning inducing the death of more of 50 % of the mice cells.




� Material control

� No fluorescence (EN 868 requirements)

� Optical Brightener Agents often used in paper industry

but not allowed in Medical / Hospital packaging


Packaging principles / Conclusion

� Choice of packaging shall depend on:� Type of sterilization to be used

� Shelf life performance to be achieved

� Type of material to be packed

� Safety of nurses, patients and for hospital environment

� Cost performance

� Hence the following applies:� Any elected item to wrap/pack must fulfill the objective related to operations in CSSDs:

� be sterilizable,

� allow efficiency of sterilization process,

� maintain barrier properties after sterilization all the way until use in OR

� proper physical protection for medical device

� A careful screening of packing/wrapping options should be conducted to allow this at best possible cost performance



Thank you

for your attention!

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