Central Service Suppl. 2012 ANNEX A.

1 | 11

Annex A.1: Validation plan checklist «pouch, reel or bag sealing»19

❑ Initial validation
❑ Revalidation (at regular intervals, only performance requalification)
❑ Revalidation for special reasons (e. g. new materials)

|| a) Competences
Name of institution (operator)

Location

Validator
(Name of persons, or companies, conducting validation)

Responsible for overall validation

|| b) Description of sealing device

Manufacturer of sealing device

Type of sealer (e. g. rotary sealer)

Serial number

Supplier
Last calibration
Contact person

|| c) Description of material
Manufacturer

Type of material

Manufacturer’s QM certificate available?* ❑ Yes ❑ No ❑ Evidence

Supplier

Contact person

CE conformity?* ❑ Yes ❑ No ❑ Evidence

❑ Paper/foil ❑ Paper/paper
Specification of material to be sealed */** ❑ Tyvek® 20/foil ❑ Nonwovens/nonwovens
❑ Nonwovens/foil Other: ________
ISO 11607 Part 1 conformity?* 21 ❑ Yes ❑ No ❑ Evidence
from _____________ to __________________
Sealing temperature range (in °C)* Specification of: __________________________
❑ Evidence available
Compatible with sterilization process* ❑ Yes ❑ No ❑ Evidence
* Information featuring an * must, in accordance with EN 868-5 and ISO 11607-1, be made available by the manufacturer of the
packaging material.
** For each material combination or each category of heat sealable sterile barrier systems a complete checklist must be filled out and the
validation process conducted.

19 If other sealing methods are used, a customized checklist must be compiled if necessary.
20 Tyvek® is a registered trademark of E.I. du Pont de Nemours.
21 Conformity with ISO 11607-1 is an absolute prerequisite and in general includes conformity with EN 868-5. Often, CE conformity
and conformity with ISO 11607 Part 1 are declared jointly in one document.
12 | ANNEX A.1 Central Service Suppl. 2012

|| d) Description of sterilization process

Sterilization process ❑ STEAM

Sterilization process validated? ❑ Yes ❑ No

Validated by:

Last validation:

Validation report number(s):

(if there is more than one sterilizer)

Next validation:

Sterilization process ❑ EO (ethylene oxide)

Sterilization process validated? ❑ Yes ❑ No

Validated by:

Last validation:

Validation report number(s):

(if there is more than one sterilizer)

Next validation:

Sterilization process ❑ VH2O2 (plasma)

Sterilization process validated? ❑ Yes ❑ No

Validated by:

Last validation:

Validation report number(s):

(if there is more than one sterilizer)

Next validation:

Sterilization process ❑ FORM (formaldehyde)

Sterilization process validated? ❑ Yes ❑ No

Validated by:

Last validation:

Validation report number(s):

(if there is more than one sterilizer)

Next validation:
Central Service Suppl. 2012 ANNEX A.1 | 13

Sterilization process ❑ Other : __________________________

Sterilization process validated? ❑ Yes ❑ No

Validated by:

Last validation:

Validation report number(s):

(if there is more than one sterilizer)

Next validation:

|| e) Qualification steps
If this is an initial validation, all three qualification steps (IQ, OQ and PQ) must be carried out as per the checklists in
Annex A.2, A.3 and A.4. For revalidation/performance requalification it may be possible to omit some steps.

Installation qualification (IQ) ❑ executed

❑ already executed during validation on:

__________________________

❑ passed ❑ failed

Date/signature : ___________________

Operational qualification (OQ) ❑ executed

❑ already executed during validation on:

__________________________

❑ passed ❑ failed

Date/signature : ___________________

Performance qualification (PQ) ❑ executed

❑ passed ❑ failed

Date/signature : ___________________

|| f) Formal approval of validation/revalidation by the operator

❑ All parts of validation/revalidation passed
❑ Parts of validation/revalidation failed
❑ Measures have been defined and documented

Place, date Name

Signature
14 | ANNEX A.2 Central Service Suppl. 2012

Annex A.2: Installation qualification (IQ) checklist «pouch, reel or bag sealing»22

Are standard operating procedures (SOPs) available? ❑ Where?

❑ Yes ❑ No
(example, see Annex A.6) __________________

|| a) General data
Device (designation/number)

Manufacturer

Manufacturer’s address

Quality management system ❑ Evidence available (certificate):

Type of sealer (e. g. rotary sealer)

Serial number

Year of manufacture

Location

Responsible for validation

Other IQ inspectors

Date of test

❑ Bar sealer ❑ Serial device

❑ Rotary sealer ❑ Special device from manufacturer

Type of device
❑ Modified device
modified by:
CE conformity?23 ❑ Yes ❑ No ❑ Evidence

ISO 11607-2 conformity? 24

❑ Yes ❑ No ❑ Evidence

Service team

Address

Telephone number

Contact person

Authorized by the
manufacturer ❑ Yes, evidence25:_______________________________________ ❑ No

22 If other sealing methods are used, a customized checklist must be compiled if necessary.
23 A heat sealer is neither a medical device nor an accesory to a medical device according the European Medical Device Directive.
24 Conformity with ISO 11607-2 is an absolute prerequisite.
25 Authorization by the manufacturer must be available in the written form.
Central Service Suppl. 2012 ANNEX A.2 | 15

|| b) Installation conditions
Parameters Required Available (measured)

Tension in volts 220 – 240 Volt ❑ Yes

Frequency in Hz 50/60 Hz ❑ Yes

Fuse protection in ampere 26

❑ Yes

Air flow rate (only for vacuum devices) 27

❑ Yes

Compliance ❑ Yes ❑ No Date/signature : ____________________

|| c) Documentation
Document Available Where (archival site)

Operating instructions ❑ Yes ❑ No

Spare parts/Order list ❑ Yes ❑ No

Compliance ❑ Yes ❑ No Date/signature : ____________________

|| d) Safety features
Parameters Required Available
Seal seam width 6 mm28
Distance to medical device 30 mm29
Compliance ❑ Yes ❑ No Date/signature : ____________________

In general, the operating instructions suffice as evidence of these aspects. In addition, the following aspects must be
verified by an authorized person:

Description Compliance Remarks

Has the sealing device been properly
❑ Yes ❑ No
connected?
Is the sealing device free of visual safety
defects (defective casing, power cables, ❑ Yes ❑ No
connector, etc.)?
Is the sealing device free of functional
defects (unknown running noise, clat- ❑ Yes ❑ No
tering, grating, etc.)?

Compliance ❑ Yes ❑ No Date/signature : ____________________

26 Please consult the manufacturer’s instructions for the fuse protection required.
27 Please consult the manufacturer’s instructions for the air flow rate required.
28 EN 868-5 § 4.3.2 «The overall width of the seal(s) shall be not less than 6 mm. For ribbed seals, the sum of the widths of the ribs
shall be not less than 6 mm».
29 German standard DIN 58953-7 § 6.3.1 «Beneath the seal seam at least 30 mm must be left between the sterile item and the seal
seam».
16 | ANNEX A.2 Central Service Suppl. 2012

|| e) Critical parameters
The following other aspects must be defined or verified by the user (evidence required in some cases):

× Sealing temperature
❑ × Contact pressure
❑
Which parameters have been defined as
critical during process development?30
❑ Sealing time ❑ Sealing speed

Issues to be clarified Compliance Evidence based on

Are the critical parameters monitored? ❑ Yes ❑ No

Are there systems available which, in
the event of deviation from pre-deter-
mined limit values for critical process ❑ Yes ❑ No
parameters, trigger an alarm or warning
or bring the device to a standstill?31
Are these critical process parameters
❑ Yes ❑ No
routinely controlled and monitored?32

Compliance ❑ Yes ❑ No Date/signature : ____________________

The following other aspects must be confirmed by providing appropriate evidence:

Issues to be clarified Compliance Evidence based on

Has the sealing device been serviced

and are written servicing plans avail- ❑ Yes ❑ No
able?
Have the essential sensors (e. g. tem-
perature sensor and DMS module) to
❑ Yes ❑ No
the process been calibrated and are
written calibration plans available?

Compliance ❑ Yes ❑ No Date/signature : ____________________

In addition, the following must be simulated and documented:

Are the parameter settings preserved in

❑ Yes ❑ No
the event of power failure?
Compliance ❑ Yes ❑ No Date/signature : ____________________

30 ISO 11607-2 § 5.2.2 «Critical process parameters shall be defined». Note: For rotary sealers the critical parameters include at least
the sealing temperature and contact pressure (monitoring of the sealing speed is recommended additionally). For bar sealers the criti-
cal parameters are sealing temperature, contact pressure and sealing time».
31 ISO 11607-2 § 5.2.4 «Alarms, warning systems or machine stops shall be challenged in the event that critical process parameters
exceed predetermined limits».
32 ISO 11607-2 § 5.6.2 «The critical process parameters shall be controlled and monitored».
Central Service Suppl. 2012 ANNEX A.2 | 17

|| f) Induction/Training
Name of trained staff Training Signature
member By Qualification Date Trainer Trainee

Only if all questions have been answered with «Yes», the required sources of evidence provided and users inducted/trained will installation
qualification be deemed to have been passed.
18 | ANNEX A.3 Central Service Suppl. 2012

Annex A.3: Operational qualification (OQ) checklist «pouch, reel or bag sealing»33

Criterion Lower limit (LL) Upper limit (UL)

1. Target temperature (as per packaging manufacturer = M ) 34

LLM = ULM =

2. Actual temperature during test (measured/read) LL = UL =

3. Requirement LL ≥ LLM UL ≤ ULM

4. Compliance with requirement from line 3 ❑ Yes ❑ No

Quality properties Compliance Compliance

Intact seal for a specified seal width ❑ Yes ❑ No ❑ Yes ❑ No

Evidence based on
_______________ _______________
Test method: ____________________*
Name/signature Name/signature
No channels or open seals ❑ Yes ❑ No ❑ Yes ❑ No

Evidence based on
_______________ _______________
Test method: ____________________*
Name/signature Name/signature
No punctures or tears ❑ Yes ❑ No ❑ Yes ❑ No

Evidence based on
_______________ _______________
Test method: ____________________*
Name/signature Name/signature
No material delamination or separation ❑ Yes ❑ No ❑ Yes ❑ No

Evidence based on
_______________ _______________
Test method: ____________________*
Name/signature Name/signature
Temperature (T) defined for PQ
(mean value from upper and lower limit values of actual temperature T = _____________
at the time of testing)
* Test methods are given in Table 3.

33 If other sealing methods are used, a customized checklist must be compiled if necessary.
34 If special materials are used (e. g. HDPE), limit values must also be calculated in sample seals if necessary.
Central Service Suppl. 2012 ANNEX A.4 | 19

Annex A.4: Performance qualification (PQ) checklist «pouch, reel or bag sealing»35
Temperature defined for the sealing process in the decontam-
T = _______________
ination circuit (carried forward from OQ checklist)
Target temperature for operational qualification (carried for-
LL = UL =
ward from OQ checklist)
Switch-off tolerance in degree Celsius as per DIN 58953-
SO = _______________
7:2010 (max. ± 5 °C)36
Resultant upper and lower value T – SO = T + SO =
Requirements T – SO ≥ LL T + SO ≤ UL
Compliance with requirements ❑ Yes ❑ No ❑ Yes ❑ No

Sterilization cycle (batch) Sterilization cycle (batch) Sterilization cycle (batch)

Criteria
A B C
Date/time of sterilization
Sterilization protocol (log) avail-
able and correct process sequence ❑ Yes ❑ No ❑ Yes ❑ No ❑ Yes ❑ No
confirmed
Sealing parameters:
Sealing temperature
Contact pressure
Sealing speed/sealing time (dwell)
Seal strength test
Free end supported ❑ Yes ❑ No ❑ Yes ❑ No ❑ Yes ❑ No
Maximum strength
Sample A: B: C:
Strength value (Smax)
Test passed
❑ Yes ❑ No ❑ Yes ❑ No ❑ Yes ❑ No
(if all values Smax ≥ 1.5 N)
Evidence based on
(name of laboratory or company)
Verification of quality properties:
Sample A: B: C:
Intact seal for a specified seal width
❑ Yes ❑ No ❑ Yes ❑ No ❑ Yes ❑ No
Test method: _____________*
No channels or open seals
❑ Yes ❑ No ❑ Yes ❑ No ❑ Yes ❑ No
Test method: _____________*
No punctures or tears
❑ Yes ❑ No ❑ Yes ❑ No ❑ Yes ❑ No
Test method: _____________*
No material delamination or separa-
tion ❑ Yes ❑ No ❑ Yes ❑ No ❑ Yes ❑ No
Test method: _____________*
* Test methods are given in Table 3.

35 If other sealing methods are used, a customized checklist must be compiled if necessary.
36 If special materials are used (e. g. HDPE), narrower switch-off tolerances must be defined if necessary (e. g. ± 3 °C instead of
± 5°C).
20 | ANNEX A.5 Central Service Suppl. 2012

Annex A.5: Example for determining the scope of process validation per heat sealer
Example from everyday practice
A Central Sterile Supply Department (CSSD) has two heat sealers, three different steam sterilization programs as well as one
formaldehyde sterilizer and one «plasma sterilizer», each with one program.
Materials are assigned as follows:

EO
FORM
STEAM (ethylene VH2O2 (plasma)
(formaldehyde)
Sealer 1 oxide)
134 °C 134 °C 121 °C
5 min 18 min 20 min
Material A
× × × ×
(see through flat pouch)
Material B
× ×* × ×
(see through gusseted pouch)
Material C
(Tyvek®)
Material D
×*
(paper bag)
EO
FORM
STEAM (ethylene VH2O2 (plasma)
(formaldehyde)
Sealer 2 oxide)
134 °C 134 °C 121 °C
5 min 18 min 20 min
Material A
(see through flat pouch)
Material B
(see through gusseted pouch)
Material C
×*
(Tyvek®)
Material D
(paper bag)

The ten combinations outlined in the table can be reduced by taking account of only the maximum material stress (worst-case
scenario, while providing documentary proof to justify this; in this example for material A and B: 134 °C/18 min as well as see
through gusseted pouch). This combination is marked with an ×* in the table.

The seal seam is subjected to the greatest stress during steam sterilization, hence this must be viewed as a «worst case».
Here in turn the program with the higher temperature must be first considered and then the longer exposure time with the
same temperature.

This example shows that in total validation must be carried out three times. A further reduction can be achieved by a deliberate
choice of sterile barrier system (e. g. see through flat pouch instead of paper bag). Accordingly, for this example the number
of validations needed would be reduced from three to two.
Central Service Suppl. 2012 ANNEX A.6 | 21

Logo of Institution Quality Management Manual Page of page

Department Scope Revision

Annex A.6: Sample standard operating procedure «heat sealing»

Note: the German standard DIN 58953-7, § 6.3 gives a guide to packing in pouches and reels. That guide has been used as a basis
for compiling this sample standard operating procedure (SOP).
1. Selecting pouches or reels
Select preformed pouches in accordance with the size of the medical device (MD).
If no preformed pouches are available in the correct size, cut reels to an appropriate size and seal at the lower edges such that
the reel section can be filled like a pouch. Alternatively, a preformed pouch can also be shortened. Neither the sterile barrier
system nor the protective packaging should be kinked or folded.
The MD may occupy at most 75 % of the pouch (DIN 58953-7).
The width chosen must allow for unimpeded introduction of the MD, but it is not advisable to use a bigger size.
The space between the upper end of the MD and the seal seam on the peeling side must be at least 3 cm (DIN 58953-7).
After sealing, an excess of at least 1 cm must be left above the seal seam (recommended in practice: 2–3 cm) to allow for un-
impeded peeling as well as aseptic withdrawal (DIN 58953-7).
When using gusseted pouches or reels the distance to the seal seam should be markedly more than 3 cm to permit orderly
sealing of original folds (the folded foil lies evenly on the paper side to prevent formation of any additional folds).

2. Packing the medical device

Insert the MD into the see through pouch such that the user can hold the gripping end (on the peel side). For reels, pay atten-
tion to the opening direction/peeling direction.
A protective must be fitted to any pointed or sharp instruments before they are placed in pouches or reels.
MDs with a cavity (e.g. kidney dish) must be arranged such that their opening will face the paper side.

3. Sealing pouches and reels

Pull tightly on the open end of pouches or reels so that the foil and paper lie evenly and free of folds in the guide mechanism
on the feed-in side of the heat sealer until the device has transported the pouches or reels and a seam has been sealed.
If necessary, manually support transport while the seal seam is being produced.
Special care has to be taken when sealing gusseted pouches and reels: formation of any additional compression or shrinkage
folds, giving rise to channels in the seal seam, must be avoided.
Recommendation: if gusseted pouches or reels can be replaced with larger sizes without a gusset this should be done in the
interest of risk minimization.

4. Visual inspection of the seal seam

Each seal must extend along the total width and length of the seal lines. There must not be any channels, kinks, folds, air
pockets or notches. There must not be any signs of burning or melting.37

37 The test method ASTM F1886 listed in ISO11607-1 Annex B «Standard test method for determining integrity of seals for medical pack-
aging by visual inspection» can be used for routine visual inspection.

Compiled: Reviewed: Approved:

Date: Date: Date:

22 | ANNEX A.6 Central Service Suppl. 2012

Logo of Institution Quality Management Manual Page of page

Department Scope Revision

5. Protective packaging in the form of an outer see through wrap

If a second wrap is specified in the packing instructions for the respective instrument, repeat steps 1 to 5, while paying at-
tention additionally to the following:
–– The pouch or reel size must permit unimpeded introduction of the inner wrap.
–– The inner see through foil must not be kinked or folded. Attention must be paid to ensuring that the inner wrap is not sealed
into the seal seam of the outer wrap.
–– Make absolutely sure that the paper side of inner pouches and reels face the paper side of the outer pouches and reels.

6. Labelling
Labels should as a rule be affixed to the foil side.
If the label is to be affixed to the paper side, the size of the label must not exceed 20 % of the paper surface.
Do not affix labels to the seal seam.
Label only outside the seal seam and outside the area surrounding the sterile MD. To that effect, use ink cassettes that meet
the requirements of DIN 58953-7.
In exceptional cases a suitable pen may be used to label outside the seal seam and the area enclosing the sterile MD. Here use
only pens that meet the requirements of DIN 58953-7 (see Annex D for Sample Data Sheet for Sterilization Markers).

7. Using a further protective packaging after sterilization

This can be done, e. g. for transport and storage, protection as well as extension of the storage time, and is documented in
the packing lists.

Compiled: Reviewed: Approved:

Date: Date: Date:

Central Service Suppl. 2012 ANNEX A.7 | 23

Logo of Institution Quality Management Manual Page of page

Department Scope Revision

Annex A.7 : Sample standard operating procedure for verification of seal seams (daily when using)
Scope
This operating procedure is intended for all CSSD personnel who have successfully completed at least Specialist Training
Course 1.

Aim
Daily routine visual inspection of the integrity and peelability of self-produced seal seams.

|| Standard reference:
Dye penetration test (ink test):
ISO 11607-1 designates the dye penetration test as a test method for verification of the integrity of seal seams (e. g. ASTM
F1929: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration).

Peel test:
EN 868-5, Annex E: «Method for determination of the peel characteristics of paper/plastic laminate products».

Materials and prerequisites:

1) Sealing device must be switched on and ready for operation (target temperature reached).
2) Dye penetration test pack (InkTest)38:
–– Suitable test ink with defined, very low viscosity
–– Pipette
–– Liquid-impermeable underlay
–– If necessary, small disposable cloth, handkerchief, or similar
3) Reel sections or pouches (approx. 20 cm width) of all see through packaging needed for the dye penetration test.
4) Reel sections of all see through packaging needed for the peel test 39.

38 Complete test packs are commercially available.

39 If only pouch packaging is used, the peel test can be omitted after sterilization.

Compiled: Reviewed: Approved:

Date: Date: Date:

24 | ANNEX A.7 Central Service Suppl. 2012

Logo of Institution Quality Management Manual Page of page

Department Scope Revision

Procedure
1) Switch on the sealing device and wait until it has reached operating temperate.

Dye penetration test (InkTest)40:

2) Switch sealing device to test mode (if applicable)41.
3) Seal an empty pouch or reel section; width at least 20 cm/length approx. 10 cm.
4) Cut the pouch approximately 5 cm above the sealing seam (the reel section is already open at the top).
5) Using a pipette, inject around 2 ml of dye penetrant into the opened pouch or reel section just above the sealing seam. Us-
ing a finger or cloth, rub the testing ink along the sealing seam from the outside.
6) After around 20 seconds, check whether the sealing seam is intact.
7) Seal leaks in the sealing seam will be visible from the penetration of test ink.

Note: If left for a long time the extremely thin-liquid test ink can penetrate the porous material (paper or Tyvek® 42) of the
pouch or reel. This is not a leak.

Peel test:
8) Introduce reel section into sealing device and seal on peel side.
9) Expose sealed reel section to a sterilization cycle.
10) Slowly and carefully peel the seal joints apart by hand. Visually check that the seal extends along the total width and length
of the seal lines. There must be no splitting of the paper more than 10 mm from the seal43. The results must be documented.

40 Seal integrity indicators (e. g. Seal Check) can also be used for routine checks of seal seams.
41 In the test mode (Seal Check mode) the critical sealing parameters as well as the name of test person, test date/time and serial number
can be printed on the test packaging.
42 Tyvek® is a registered trademark of E.I. du Pont de Nemours.
43 Requirement as per EN 868-5, Annex E

Compiled: Reviewed: Approved:

Date: Date: Date: