Funcionality of sterile barrier systems

focussing on the system flexible sterile

barrier test
Anke CarterNome
Germany
do autor
German Society
for Sterile Supply

Greetings from Germany

Boa tarde senhoras e senhores

Muito obrigado por me convidar para So Paulo!
Best regards for a successful conference
from my collegues on the
Board of the German Society for Sterile Supply

Flexible Sterile Barrier Systems

Paper - film laminates

Non woven - film laminates
Heat sealable, easy to peel pouches & reels
Sterilisation compatibility:
STEAM
EO
FORM

Flexible Sterile Barrier Systems

Materials:
Crepe paper
Non-woven (pulp+plastic fibres)
SMS (multi layer material from spunbond
and meltblown polypropylene
-100% poliolefine material)
Sterilisation compatibility:
STEAM
EO
SMS is also ok to use in FORM and PLASMA

Sterile barrier systems

Rules and Regulations

ISO 11607: Packaging for terminally sterilized medical devices

Part 1: Requirements for materials, sterile barrier systems and packaging
systems (ISO 11607-1:2006); German version EN ISO 11607-1:2009
Part 2: Validation requirements for forming, sealing and assembly processes
(ISO 11607-2:2006); German version EN ISO 11607-2:2006
DIN CEN ISO/TS 16775:2014-10- Pre publication: Packaging for terminally sterilized
medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
(ISO/TS 16775:2014); German version CEN ISO/TS 16775:2014

Sterile barrier systems

further Rules and Regulations

EN
EN
EN
EN
EN
EN
EN
EN
EN
EN

868
868
868
868
868
868
868
868
868
868

- 1: general requirements of packing materials (replaced by ISO11607)

- 2: Wrapping paper & non woven
- 3: Paper for Paper-film laminates
- 4: Paper bags
- 5: See through pouches and reels
- 6: packing materials for EO gas and radiation sterilization
- 7: adhesive coated papers for ethylene oxide or irradiation
- 8: reusable container
- 9: uncoated nonwoven material (Tyvek)
-10: coated nonwoven material (Tyvek)

Are those Standards important for work in Sterile Supply?

Yes, because the main purpose of any packaging system used for sterile Medical
Devices is

to preserve sterility until use

to allow aseptic presentation at the point of use

Standards provide a framework how to carry out packaging of Medical Devices to be
sterilized

If standards are followed, aseptic presentation is possible, because everyone knows
how the packaging can be opened

Standards do not include clear instructions for testing whether the packed items are
sterile at the point of use

Guideline for the validation of packaging processes

according to ISO 11607-2

The international standard ISO 11607-1 describes essential requirements for sterile
barrier systems, while the ISO 11607-2 standard describes validation of packaging
processes. Detailed quality requirements for sterile barrier systems are outlined in the
European CEN standards EN 868-2 to 10.
Those Standards serve as a rule for the Guideline for the validation of Packaging
processes
The Guideline serves as an orientation for conducting validation

Validation of procedures of
(Re)processing Medical Devices

Validated automated processes are

Manual processes to be validated

 Steam sterilization (EN ISO 17665)

Manual cleaning and disinfection

 Cleaning and disinfection (EN ISO 15883)

Vision control

 Sealing of pouches (EN ISO 11607)

Functional control

 Formaldehyde sterilization (EN 14180)

Lubrication

 Ethylene oxide sterilization (EN ISO 11135)
Packaging (DGSV )

Quality Management is the key to standardization and validation of procedures

Responsibility for Validation of processes

The Hospital or the Central Service provider are responsible for validation
There has to be profound knowledge of the procedure of validation, therefore

Validation has to be a part of the education for CSSD Managers and staff

Validation of automated processes is carried out with support of technicians who
know about the function of the Washer-disinfectors, sterilizers and sealing machines

Validation of manual processes depends largely on the Personnel working in CSSD

Guideline for the validation of packaging processes

according to ISO 11607-2

The packaging process is one of the links

in the circle of medical device
reprocessing and, as such, must be validated.
Quality management is a prerequisite for
validation
During validation, different tests are carried out
for flexible packaging

Guideline for the validation of packaging processes

according to ISO 11607-2

Validation
includes

Installation
Qualifikation
IQ

Operational
Qualifikation
OQ

Performance
Qualifikation
PQ

How can the guideline support?

Text of the Guideline explains

about the procedure of validation

Checklists offer support

Working with Checklists

Carrying out tests during Validation

Tests to be carried out on flexible materials during validation

- Visual tests on all flexible material including photo documentation
- Checking the work performance by inspection during packaging
- Seal Check on Pouches
- Ink test on Pouches
- Seal strength test

Routine work with flexible packaging materials

Once validation is completed, work has to be carried out by everyone according to the Standard
operating procedures at all times.
Routine tests will have to be carried out as stated in the validation report.
The quality of working with flexible materials depends largely on the personnel involved in the
packaging!
Remember: There are no automated records of packaging.
Quality management rules have to be applied and can be used as proof, if necessary!

What is next?
Brief look into the future

The next step on testing the functionality of flexible packaging materials will take place
at the users site, i.E in an operating theatre.
Storage time is not time related, but event related, so the question arising
How long can sterilized items be stored before they are used?
To find the right answer to this question, a lot more work will have to be put into the
subjects of transportation and storage of sterilizes medical devices.

THANK YOU

Very much for your attention during the presentation!

I am looking forward to the discussion!