The document discusses sterility maintenance and shelf life management. It covers topics such as material requirements for sterile packaging, packaging system design validation processes, and maintaining sterility and shelf life. Specifically, it emphasizes the importance of using cellulose fibers rather than linen for packaging due to linen's absorbency which can allow contamination. It also notes that double sequential wrapping provides better barrier protection than single wrapping.

1. ROYAL COMMISSION MEDICAL CENTER
YANBU AL SINAIYAH
STERILITY MAINTENANCE
SHELF LIFE MANAGEMENT
PRESENTED BY :
HATHROUBI MUNEER
RCMC CSSD OFFICER

2. OBJECTIVES
 To understand how contamination can occur and when
microorganisms can be introduced into a sterile package.
 To realize the importance of the selection of the pack and the
correct technique of packaging that can protect the sterile
goods.
 To confirm the importance of using Cellulose fibers instead
of linen.
 To understand the importance of packaging, and the storage
condition for sterility maintenance and Shelf life method and
the responsibility of the user.

3. HISTORY
 The SMITHSONIAN INSTITUTE has flasks
that were sterilized in 1863 by LOUIS
PASTEUR; these flasks are still sterile after
more than 140 years.

4. DEFINITION
 Shelf life is the period of time during which a sterile item is
considered safe to use.
 Shelf life is considered to be event –related not time related. That
is while the probability of contamination increases with time, it
is more influenced by handling and storage methods.
 Sterile items that are protected from the environment have been
proven to remain sterile indefinitely.
 Shelf life is not matter of sterility maintenance. Many products
from outside manufacturers carry out expiration dates that relate
to product and packaging degradation, not to product sterility per
se.
 It is important that sterile items be properly stored so that the
packaging is not compromised.

5. RISK MANAGEMENT
RE-USABLE
INSTRUMENT
Cleaned / Wrapped /
Disinfected
S Packed
RISK MANAGEMENT Sterilized
FOR HEALTH OF PEOPLE
Sterile until use
- Select correct material.
- Validation of the concept.
- Validation of processes for packaging.
-Sterility maintenance.
5

6. TOPICS
 1- MATERIAL REQUIREMENT
 2- PACKAGING SYSTEM DESIGN
REQUIREMENTS
 3- PROCESSES VALIDATION
 4- STERILITY MAITENANCE SHELF
LIFE

7. Topics
 1- MATERIAL REQUIREMENT
 2- PACKAGING SYSTEM DESIGN
REQUIREMENTS
 3- PROCESSES VALIDATION
 4- STERILITY MAITENANCE SHELF
LIFE

8. Key Characteristics of Sterilization Wraps
Most experts and organizations agree on several key characteristics of wrapping and packaging:
• Barrier effectiveness prevents contamination and maintain sterility.
• Permeability/penetrability allows for the effective penetration of
sterilants (steam, ethylene oxide, plasmas, irradiation, ozone and
moisture).
• Aeration allows for the post-sterilization dissipation of moisture and the
sterilants used.
• Efficiency of use means the product can be easily inserted, maintains
"seal integrity," has the ability to conform to the contents and has ease
of presentation to the sterile field maintaining aseptic technique.
• Drapability means the wrap conforms to the contents and contours of
the product/instrument and can opened on a flat surface or held out of
the sterile field during presentation
• Flexibility accommodates any size or shape article.

9. Key Characteristics of Sterilization Wraps
• Durable package integrity means the wrap resists punctures, tears and
abrasions. Conforms to measurement standards for tensile
strength, porosity and moisture vapor transmission rates.
• Toxin free means non-toxic and non-fast dyes prevent adverse physical
reaction of handler or change/coloration of the contents or wrapper.
• Odor free characteristics prevent any allergic reactions from inhalation
of chemical processes used in manufacturing or laundering.
• Lint free/minimal linting means the wrap is devoid of or contains
minimal linting properties (Gelbo Lint INDA Standard testing method
160-1-92) .
• Cost effectiveness ensures the wrap is economical, saves time and
reduces waste without compromising aseptic technique.
• Content verification means the ability to identify the internal contents
of the product produced visually or by labeling.

10. How to consider the choice of
packaging?
 Question:
How to be sure that the medical device placed in the wrap packaging is still
sterile when introduced in operating room ?
 Problematic:
There is no destructive and routine test able to determine if the barrier
integrity of the pack is still valid
 Answer:
Compliance to EN ISO 11607 part 1 & 2
Part 1 : Requirements for material and Packaging System Design
Part 2 : Validation requirements of processes for packaging
3 requested conditions:
1- Have the adequate material
2- Have a validated packaging system design
3- Follow a protocol from packaging to operating room with regular
check of the integrity of the packaging

11. Different options of packaging…
Wraps Cellulosique paper Linen
Wet laid non-woven SMS (PP)
Containers
Pouches Cellulosic paper
PEHD (flash spun bond)
11

12. Sharp instrument tip protection

13. Topics
 1- MATERIAL REQUIREMENT
 2- PACKAGING SYSTEM DESIGN
REQUIREMENTS
 3- PROCESSES VALIDATION
 4- STERILITY MAITENANCE SHELF
LIFE

14. Role of packaging
Allow sterilization AND provide a high bacterial barrier
performance during the storage of the sterilized packs
Sterilizing agent Micro-organisms
____________
Bacterial barrier against contamination coming from:
- Air (airborne, micro particles, dust)
- Fluids (drops, aerosols)
14

15. Microbial barrier
 The principle of bacterial barrier is that bacteria die / burn their
energy before crossing barrier material  Tortuous path
 Part of the non-compliant materials are the ones which are not
barrier enough to stop bacteria on their way
Film to paper pouches poorly manufactured (no sealing
in some areas)
Materials with holes or with insufficient tortuous path
15

16. Microbial barrier : Focus on linen
LINEN CELLULOSE
MATERIALS
Easy pénétration of Dense and matted layers of
micro organisme cellulosique fibres blocking
micro organisme
16

17. Microbial barrier : Focus on linen
CELLULOSE
LINEN
MATERIALS
Water
drop
Fluide droplet in contact with linen and with Cellulose Sterisheet® material .
Due to the natural absorbancy of linen, the droplet passes straight through.
With the repellent qualities of Sterisheet® the passage is inhibited.
17

18. Microbial barrier : Focus on linen
DRY STATE WET STATE
Germ Bacterial Germ Water
Proofness Filtration Proofness resitance
Efficiency EN 868-2 Annex B
Non woven
Cellulose fibers- PASS 96% to 99% PASS 30s
crepe paper pulp,
plastic polymers
Non woven
Cellulose fibers- PASS 85% PASS 25s
Wet laid
Woven Textiles
FAILED 48% FAILED 2s
(new Linen)
Woven Textiles (re-
FAILED 17% FAILED 0s
usedLinen)
18

19. How to validate that the design of your
packaging system is adapted ?
:Validation of the packaging system design by real test & good practices
 Several wrapping methods
- Envelope folding
- Square folding
- Pasteur folding
- Roll method
 The most common and recommended folding is envelope folding
 Why?
- To create the more tortuous path which means a better
barrier against penetration of micro-organism
Design validated by Event-Related Sterility Maintenance Study
- Reduce handling during opening 19

20. How to validate that the design of your
packaging system is adapted ?
 Double sequential wrap is recommended
 Why?
-Bacterial filtration efficiency & germproof ness test
(DIN 58953-6 2.14 & 2.15) is improved.
- Guarantee aseptic opening
- Possibility to combine different generation wraps.
-Can offer a combination of the best characteristics and benefits of each
generation of products.
-Provide the most adapted wrapping solution and a tailored made wrapping
system.
-Possibility to have a colour coding :Security : Superposition of two colours
allows to visualise any defect & prevent dust cover entering the operation rooms
20

21. Validation of the double wrapping Vs
single wrapping
double sequential wrapping

22. Validation of the double wrapping Vs single
wrapping
Bacterial Filtration Efficiency test (ASTM F2101)
Double Wrapping
BFE Single Wrapping
(interleaved)
Cellulose fibers, paper 85% to 99% 95% to 100%
New Linen 48% 75%
Re-used linen 17% 59%
22

23. Notes
 The three Cellulose Materials wraper sheet generations offer
high bacterial barrier performances, making Cellulose
Materials a true sterilization wrap. The Bacterial Filtration
Efficiency test (BFE) which measures the ability of any given
material to withstand penetrations by bacterias, show readings
of up to 98% for Cellulose Materials crepe papers.
Furthermore, all Cellulose Materials wraps pass the DIN
Bacterial barrier Test considered one of the most severe and
realistic test designed up to date.
 Linen, on the contrary, show poor Bacterial Filtration
Efficiency readings (17% for reused linen), do not pass the
DIN test and therefore do not offer any protection to
penetration of bacterias.

24. Topics
 1- MATERIAL REQUIREMENT
 2- PACKAGING SYSTEM DESIGN
REQUIREMENTS
 3- PROCESSES VALIDATION
 4- STERILITY MAITENANCE SHELF
LIFE

25. How to validate that the design of your
packaging system is adapted ?
Validation of the packaging system design by real test & good practices
 Efficiency of sterilization :
Steam penetration testing thru activating sterilization indicators
 Integrity of the packege / Maintenance of sterility integrity over time :
Event-Related Sterility Maintenance Study (Nelson laboratories)
This test is performed on double-layer packaging after sterilization, and
simulates shelf storage – inside a room whose humidity and temperature
are regularly recorded – along with weekly handling of the packaged
packs. The packs are inspected after period of 180 days and the results is
given as the percentage of uncontaminated packs.
Microbial aerosol challenge test (Nelson laboratories)
aerosolizing high number of Bacillus atrophaeus spores and then testing
the contents of the package for ingression of that organism.
25

26. Validation of the maintenance of sterility
over time
Event-Related Sterility Maintenance Study
30 days 180 days
Cellulose fibers, paper 100% 100%
New Linen 76% 66%
Re-used linen Not tested
Tested on double sequential wrapping
26

27. Topics
 1- MATERIAL REQUIREMENT
 2- PACKAGING SYSTEM DESIGN
REQUIREMENTS
 3- PROCESSES VALIDATION
 4- STERILITY MAITENANCE SHELF
LIFE

28. GUIDELINE FOR PACKAGIN
 All the items must be carefully checked before packing
 Medical devices
• check the medical devices are clean
• check the medical devices are not damaged
- no stain / no corrosion
• check there is no residual water
• check all items for a given procedure are there
 Sterilization sheets
• check if packaging product is clean, without any holes & tears &
secure its tracking number trace ability feature
 Packing area
• prepare a clear & clean area
28

29. PROTOCOL FOR VALIDATION OF
PACKAGING PROCESS
Condition A written protocol and visual aids for each step:
1- Packing preparation
2- Sterilization (Loading)
3- Transportation
4- Storage
5- Opening
Only a visual inspection, will guarantee the integrity of the
packaging
At the end of each stage, a visual inspection must be
performed thru a documented quality system including
records, training & qualifying any actor of the chain
Following guideline is based on these 3 conditions and the
results of in situ testing, experience & good practices
29

30. Topics
 1- MATERIAL REQUIREMENT
 2- PACKAGING SYSTEM DESIGN
REQUIREMENTS
 3- PROCESSES VALIDATION
 4- STERILITY MAITENANCE SHELF
LIFE

31. STERILITY MAITENANCE SHELF
LIFE
 Shelf life refers to the period of time any disinfected or
sterilized item is safe to use.
 The time an item remains safe for use is more event-related
than time-related.(Actual sterility may be indefinite
depending on the package materials, the item itself and the
handling and storage).
 Some manufactured items have a label claim of “Sterility
guaranteed unless packaged is punctured or broken.” This
labeling claims indefinite shelf life under the condition of
proper handling and storage.

32. ROTATION OF THE STOCK
 Rotation of stock entails a system of adding
newer sterilized items to an inventory to
enable the use of the oldest first to prevent
stale dating. When we go to the supermarket
we always do the opposite: we look for and
select the items that are freshest. In
contrast, in dispensing we should select the
oldest dated sterile items and use them first.

33. COMPROMISET CONDITIONS
 Any package with puncture, or dropped on
the floor, rough
handled, bended, creased, getting wet or
damp, writing on the paper
portion, pressurized and impacted.
 Packages that are found to be bent, damp etc.
are considered no longer fit for service and
require re-processing.
puncture

34. GUIDE LINE FOR STORAGE
 shelf life of a package sterile is event related not time-related
Sterile items should be stored in a manner that reduces the potential for
contamination
• Storage area dedicated to sterile supplies
• Temperature and humidity controlled (Room temperature between 22 & 24 C & Humidity does not
exceed 70%)
• Away from direct sunlight
• Traffic should be controlled to limit access to sterile items.
• Sterile items stored far enough away from the floor, the ceiling, and outside walls
to allow for adequate air circulation
• Avoid friction of packs against the shelves during handling
• first in / first out policy
•Written policies and procedures should be developed for the storage, handling and rotation.
34

35. WHERE ARE WE ?
COMPARISON BETWEEN OUR RCMC
CSSD & OTHER FACILITY CSSD

36. OTHER CSSD FACILITY

37. RCMC CSSD

38. RCMC CSSD

39. OTHER FACILITY
DECOTAMINATION AREA

40. RCMC CSSD
DECONTAMINATION

41. OTHER FACILITY CSSD
PROCESSING AREA

42. OUR PROCESSING AREA

43. OTHER FACILITY PACKAGING
AREA

44. PACKAGING AREA

45. OTHER FACILITY STERILE
STORAGE ROOM

46. RCMC CSSD STERILE STORAGE
ROOM

47. MESSAGE
 The following guidelines should be observed when opening sterile packages:
•Remove the outer wrap before entering the OR, not to
introduce exterior micro-organisms.
• Enter the OR with the inner wrap only
 Aseptic technique presentation
If the material is a non woven resistant to
disinfectants, it can be used as sterile field
• Internal indicators should be checked to confirm before the
appropriate end point response

48. MESSAGE
Opening sterile packages
• Before it is opened, the package should be inspected for the
appropriate appearance of the external sterilization indicator and
the physical integrity of the packaging
 Last and more crucial inspection
 Place visual aids of final packaging
inspection & refused package in this
area if compromised.
48

53. ISO 11607-1 : Material Requirements
 Example of what RCMC CSSD done to be in compliance with ISO 11607-1 for material
requirements ( during the period of preparation for the JCI survey).
 Documentation provided by the supplier
Key properties Requirements Compliance demonstrating Tools:
to be evaluated Standards & appropriate Test
methods
Microbial barrier Porous material shall provide an Tests listed in EN 868-2
adequate microbial barrier Bacterial Filtration Efficiency (ASTM F2101)
Germ Proofness (DIN 58953-6 § 2.14 & §
2.15)
Biocompatibility & toxicological Biocompatibility ISO 10993
attributes Sensitisation / Irritation / Cyto- ISO 10993
toxicity EN 11737
Bio-burden control EN 868-2
Chemical properties
Physical & chemical properties Physical & chemical properties Tests listed in EN 868-2
follow-up
Compatibility with respect to Folding EN 868-2
forming and sealing processes Drape ability EN 868-2
Compatibility with respect to Suitability for use in sterilization EN 868-2 after sterilization
the intended sterilization processes and cycle parameters
processes
Acceptable shelf-life Any shelf-life limitations for pre- EN 868-2
sterilization and post-sterilization storage Bacterial Filtration Efficiency (ASTM F2101)
Germ Proofness (DIN 58953-6 § 2.14 & § 2.15) on
5 years aged paper, before and after sterilization
53

54. What can be done against nosocomial
diseases?
 Good practices:
- Hand washing
- PPE (gloves, gowns..)
- Medical and surgical equipment care:
- Cleaning
- Disinfection
- Packaging
- Sterilization of reusable medical devices
- Traceability
- Preference of single use devices
- Good sterilization method.
- Good storage technique.