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Form Ref. ST-64300/65300 Rev.: B2
Date: 28 May 2015
STERIKING See-through Reels with 3 Indicators

The STERIKING See-through Reels with 3 indicators are for use as packing material for medical
devices in sterilization by steam, ethylene oxide gas or formaldehyde in health care establishments. The
common steam sterilization conditions are 3 minutes at 134C or 15 minutes at 121C. The products are
for single use only.
Conformity to International Standards
The STERIKING See-Through range of peel
packages conform to the international product
standards and norms: ISO 11607-1:2006, ISO
11607-2:2006, EN 868-5:2009.
The products are registered under Class 1 as
accessories in compliance with the European
Medical Device Directive 93/42/EEC and its
amendment 2007/47/EC. To show compliance
with MDD the CE mark is printed on the label of
the transport carton.
The products are registered by FDA under 510(k)

Premarket Submission No. 953776.
Wipak Oy is certified to ISO 9001:2008; ISO
14001: 2004; OHSAS 18001: 2007, ISO 22000:
2005 and ISO 13485:2003.
STERIKING sterilization packages are
designed, validated, and manufactured to suit
their intended purposes.
Technical Data & Performance Characteristics

2
The STERIKING See-Through packages are constructed of medical grade paper (70g/m ) is heat
sealed together with a multiply PET/PP-plastic laminate (12/40 microns). Recommended sealing
temperature for final closing is 165-200C (329-392F) depending on pressure and time.
Specific Product Features
Dimensions and Tolerances
Width:
nominal +/- 2 mm
Length:
nominal +500, -0 mm
Heat Seal Design
The seal is formed to facilitate easy opening. The width and the strength of the seal are specified in order to
achieve the optimum strength necessary for autoclaving and at the same time to facilitate easy opening of the
pack. The seal is ribbed having 3 aligned sealed lines and the total width is minimum 6 mm.
Heat Seal Strength
Flat reels:
Minimum strength with tail supported
up to 100 mm wide
140 N/m ( 2.1 N/15 mm )
wider than 100 mm
165 N/m ( 2,5 N/15 mm )
Gusseted reels:
165 N/m ( 2,5 N/15 mm )
Splices and Joints
Reels 200m:
max. 2 per reel
Reels 100m:
max. 1 per reel
Direction of Peel
The correct direction of peel is marked on each individual reel at specified intervals in order to ensure safe
opening without breaks and/or fiber tear.
Lot Coding
Each reel bears a code number enabling traceability of the production history.
The code is YYMM (year / month). Converting lane numbering offers added value for production traceability.
Chemical Indicators
conform to ISO 11140-1:2014 type 1: Process indicators.
Steam indicator change from red/pink to brown,
EO gas from pink to gold/ochre and
FO gas from pink/red to green
Wipak Oy Medical Division Phone +358-(0)20-510 311 Fax +358-(0)20-510 3333

E-Mail [email protected] Websites www.wipak.com www.steriking.info
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Form Ref. ST-64300/65300 Rev.: B2
Page 2 (3 )
The paper is a high-weight medical grade with improved barrier and water repellent properties. The controlled pore
size provides for effective air evacuation and steam penetration. The specially treated surface facilitates strong
sealing against the film but allows fiber-free peeling off without breaks. The paper conforms to the requirements of
the European EN 868-3:2009 and it is free from dirt, toxic substances and odor.
Medical Grade Paper

Property
Grammage
Tensile strength, MD
Tensile strength, CD
Tear strength, MD
Tear strength, CD
Burst strength
Air permeability
Air resistance Gurley
Sterilization method
Test Method
ISO 536
ISO 1924-2
ISO 1924-2
ISO 1974
ISO 1974
ISO 2758
ISO 5636-3
ISO 5636-5
Steam, gas
Unit
2
g/m
kN/m
kN/m
mN
mN
kPa
m/Pas
s
Typical
70
7,3
4,0
700
750
400
13
11
Tolerances
67-73
>5,1
>2,6
>550
>550
>270
5,3-14,2
9-20
The Wipak Multi-X9 film is transparent, non-toxic and heat sealable with medical grade paper. It can be sterilized at
the extreme sterilization conditions of 140 C (284 F) for 10 minutes. In addition it can be sterilized using low
temperature sterilization methods (other than irradiation). The materials have been permitted for use in contact with
food and drugs by the German BGA and the American FDA.
Multi-X9 Film
Property
Method
Unit
Nominal
Thickness
52
Weight
g/m
53
Tear strength, MD
ISO 6383-2
mN
300
Tear strength, CD
ISO 6383-2
mN
300
Elongation at break, MD
ISO 527-3
70
Elongation at break, CD
ISO 527-3
70
Sterilization method
steam, gas
MD= machine direction, CD= cross direction Test conditions: 23C, 50 RH-%
Storage Recommendations & Shelf Life
Restrictions in Use
It is recommended that the STERIKING products are kept

in the original, closed transport carton and are stored in dry
and clean conditions protected from direct sunlight and
excessive moisture.
The STERIKING standard range of See-Through 3

indicator Reels is not suitable for sterilization by irradiation
or by hot, dry air at the temperatures over 140 o C. Some
restrictions may also be valid when plasma sterilization
processes are concerned.
It is recommended that the products are put to their end use

within 5 years of manufacture. The recommended Best
before date and the manufacturing date are stated on the
carton label. However, depending on the requirements of
the user, products older than five years may still be useable
if the storage conditions have been according to the
recommendations. No collapsing of performance of the
product will take place after any time period. In the cases
where the recommended expire date has been exceeded it
is advisable to test the product prior to use.
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Form Ref. ST-64300/65300 Rev.: B2
Sales and Transport Packing

Each reel is wrapped in a polyethylene dust cover (LDPE)
and then packed in an unbleached corrugated cardboard
case (partially recycled and further recyclable). The case is
closed with adhesive coated polypropylene tape. Cases are
palletized to reusable wooden EUR size pallet and covered
by plastic pallet-tightening bands (PET). Partially recycled
and further recyclable cardboard-sheet is placed on the
bottom of the pallet.
Please refer to the local/national regulations regarding
waste disposal.
Page 3 (3 )
Labeling: Each case bears a label with the necessary

information/instructions for the contents of the case in
accordance with ISO 11607-1:2006 and EN 868-5:2009.
In Case of Complaint
In event of any complaint, the lot number and identification
code must be provided by the complainant. For evaluation
of claimed product, a defective sample (or a digital photo)
and description of the defect together with an unused
specimen must be made available to Wipak.
STERIKING is a registered trademark of Wipak Oy.
Steriking Flat Rolls

Code
Size (mm)
R39
R40
R41
R125
R42
R43
R44
R45
R46
R47
50 : 200
75 : 200
100 : 200
125 : 200
150 : 200
200 : 200
250 : 200
300 : 200
350 : 200
400 : 200
Sales Packing
(Rolls/Case)
5
4
3
2
2
1
1
1
1
1
Steriking Rolls with Gusset

Code
Size (mm)
RB50
RB51
RB52
RB53
RB54
RB55
RB56
RB57
75 x 25: 100
100 x 50: 100
150 x 50: 100
200 x 55: 100
250 x 65: 100
300 x 80: 100
350 x 80: 100
400 x 80: 100
Steriking R/31-Flat Rolls
Steriking R/100-Flat Rolls

Code
Size (mm)
R39/100
R40/100
R41/100
R42/100
R43/100
R44/100
R45/100
R47/100
R49/100
50 : 100
75 : 100
100 :100
150 : 100
200 : 100
250 : 100
300 : 100
400 : 100
500 : 100
Sales Packing
(Rolls/Case)
8
8
4
2
2
2
1
1
1
Sales Packing
(Rolls/Case)
4
3
2
1
1
1
1
1
Code
Size (mm)
R39/31
R40/31
R41/31
R42/31
R43/31
R44/31
R45/31
50 : 31
75 : 31
100 : 31
150 : 31
200 : 31
250 : 31
300 : 31
Sales Packing
(Rolls/Case)
10
10
10
16
6
6
6
This specification refers to the named product group and shall be valid until the next revision. Other product related documents
may be available upon request.
The information contained here is to our knowledge accurate and reliable as of the date of the publication. Wipak extends no
warranties and makes no representations as to the accuracy or completeness of the information contained herein, and assumes
no responsibility regarding the consequences of its use or for any printing errors. It is the customers responsibility to inspect and
test our products in order to satisfy himself as to the suitability of the products for the customers particular purpose and suitability
to the actual circumstances the product is exposed to. The customer is also responsible for the appropriate, safe and legal use,
processing and handling of our products especially when recommendations for safe use and storage are given. Nothing herein
shall constitute any warranty, nor is a protection from any law or patent to be inferred.

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STERIKING See-through Reels with 3 Indicators

The products are registered by FDA under 510(k)

Technical Data & Performance Characteristics

Wipak Oy Medical Division Phone +358-(0)20-510 311 Fax +358-(0)20-510 3333

Medical Grade Paper

Storage Recommendations & Shelf Life

It is recommended that the STERIKING products are kept

The STERIKING standard range of See-Through 3

It is recommended that the products are put to their end use

Sales and Transport Packing

Labeling: Each case bears a label with the necessary

Steriking Flat Rolls

Steriking Rolls with Gusset

Steriking R/31-Flat Rolls

Steriking R/100-Flat Rolls

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