QUALITY assurance for

Sterile Barrier Systems

Manfred Blunk 02.05.2017

www.stericlin.de

Sterile Barrier Systems

requirements for QUALITY

Does the product is in compliance with international standards

Does it is maufactured in a clean room

Does it is a validated product

Does there is a 3rd party confirmation for barrier function

Does there is a 3rd party confirmation for sterilization compatibility

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 Sterile Barrier Systems

What is needed for QUALITY production of pouches and reels

Class 8 Clean room production as per ISO14644-1 and -3

Pouches and reels comply with ISO11607 and EN868

Validated manufacturing processes as per ISO11607

3rd party laboratory confirmation for ISO11607 and EN868

Gapless traceability from raw material till the finished product

Bio burden as per DIN EN ISO 11737-1 is tested every 3 month and confirmed
lower than 100KBE
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Certificate of Compliance ISO11607

by 3rd party laboratory ISEGA Germany

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 Look for the right QUALITY

It is not a question of like or don‘t like Quality

It is not a question of want to have Quality or not

It is a question of safety and health for patients

QUALITY is our responsibility

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How to find the right Quality of Sterile Barrier System

A Standard to look for in Medical Packaging is

ISO 11607
and as a part of it EN 868 part 2 for wrapping materials and
parts 3 and 5 for pouches and reels

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 ISO 11607

Part 1
covers the requirements for materials,
Sterile barrier systems and packing systems
mainly for manufacturer

Part 2
covers packing for terminally sterilized medical devices,
validation requirements for forming, sealing and assembly
processes
this part is the one to guide you to validated quality in your
hospital

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How to recognize QUALITY

• Regulatory quality
• Standards conformity
• Certification quality
• Functional quality
• Barrier properties
• Sterilisation compatibility
• Opening characteristics
• Design quality
• Safety aspects
• Traceability aspects
• Economical quality
• pricing and cost
• Reliability of supplies ….

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 Appropriate heat sealable
Sterile Barrier Systems
pouches and reels
paper/film non-woven/film Tyvek/film

All in conformity with ISO11607-1

and EN868
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Appropriate Sterile Barrier Systems

Wrapping sheets

Common Materials:
Crepe paper Bonded Double Wraps

Single Sheet Wraps Non-woven

SMS

All in conformity with

ISO11607-1
and EN868-2

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 Appropriate Sterile Barrier Systems

Container

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Appropriate Sterile Barrier Systems

Manufacturing of Sterile Barrier Systems

must be in a clean room to avoid/minimize
contaminations and dirt’s

Ask for a certificate of clean room production

minimum class 8 as per ISO 14644-1:1999

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 Requirements of ISO11607-2
for Sterile Barrier Systems

The packing material used must be suited to and defined for the
intended packing and sterilization processes

The supplier must provide conformity certificates as per

ISO11607-1
and sections of the EN868, parts 2-10
in respect of:

- microbial impermeability
- compatibility with the sterilization process

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Thickness of paper

60g/m² is the minimum weight for pouches and reels

70g/m² for quality pouches and reels as per market experience

higher safety standard
much better performance for aseptic presentation
less paper fiber tear while peeling

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 Printing requirements

In case the manufacturer has validated the manufacturing process

only ISO 11607 can be printed
other printed standards are not valid

Size of product must be mentioned

Date of manufacturing to control the shelf life and lot number

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Printing requirements
No printing at the filling area
as the medical item is not allowed to get in touch to the printing color

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 Printing requirements

Printing rapport of indicators on reels shall not be more than 155mm

Do not use if pack is damaged single use only and brand opening direction

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Printing requirements

Thumb cut as opening support must be provided at pouches

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 Sterile Barrier Systems
appropriate loading in sterilizer chamber
Load configuration must be validated to achiev continous Quality

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Sterile Barrier Systems

appropriate loading in sterilizer chamber
Load configuration must be validated to achiev continous Quality

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 Sterile Barrier Systems
appropriate Storage conditions as per DIN58953-8

• Storage room must be dry, dark, air conditioned and easily to clean

• Room climate: 15°-25°C

• Relative humidty: 35 - 50%

• Storage room must be free from insects

• No influence by sun light (UV light)

• No contacts to desinfactants and solvents as it can break the sterile

barrier of the paper

• Storage room is not accessible for everybody

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Sterile Barrier Systems appropriate storage conditions

Propper conditions

Unpropper conditions
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 Storage time recommendation
to safe Quality

Storage time table according to DIN 58953, part 8

type of sterile barrier system storage unprotected storage protected

compliant with
ISO 11607 / EN 868 (without dust protection, (dust protected, e.g. in
e.g. on shelves) cupboards or drawers)
Primary packings: intended for immediate use 6 months , but not longer than
sterile single wraps maximum shelf life
and / or not to be used for storage
sterile double wraps time longer than 48hours
Storage packings:
single or double wraps in a max 5 years if no other statement from the manufacturer site
sterile storage package = dust
cover, not opened or opened
and re-closed

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PLEASE VISIT OUR NEW WEBSITE: www.stericlin.com

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