Gap Analysis of ISO 11607-2: 2019 & ISO 11607-2: 2006

2019
Clause Clause
No Clause Gap/Description No
1 Scope 1
2 Normative
reference 2
3 Terms and
Definitions 3

3.1 Aseptic presentation- transfer of sterile contents from its

sterile barrier system using conditions and procedures that
minimise the risk of microbial contamination
3.2 Closure- means used to complete a sterile barrier system
where no seal is formed
3.3
Control- regulation of variables within specified limits
3.4 Expiry date 3.1
3.5 Installation qualification 3.2
3.6 Labelling 3.3
3.7 Medical Device
3.8 Microbial Barrier
3.9 Monitoring
3.10 Operational qualification 3.4
3.11 Packaging System 3.5
3.12 Performance qualification 3.6
3.13 Preformed Sterile Barrier system 3.7
3.14 Process Parameter
3.15 Process Specification
3.16 Process variable
3.17 Product 3.9
3.18 Protective packaging 3.10
3.19 Repeatability 3.11
3.20 Reproducibility 3.12
3.21 Reusable container 3.13
3.22 Seal
3.23 Seal Strength
3.24 Sterile
3.25 Sterile barrier system 3.14
3.26 Sterile fluid path packaging 3.15
3.27 Terminally Sterilised
3.28 Validation 3.16

3.8
 4 General 4
Requirements
4.1
4.1 Activities described in this document shall be carried out 4.1.1
Quality Systems within a formal quality system
4.1.2

4.1.3

4.2 Risk the activities described within this document shall consider
Management risk management to medical devices
4.3 Sampling plan used shall be validated and based upon
Sampling stastically valid rationale 4.2
4.4 Test Methods
4.4.1 A rationale for selection of appropriate tests for packaging
system shall be established and recorded 4.3.2
4.4.2 A rationale for acceptance criteria shall be established and
recorded 4.3.2
4.4.3 All the test methods used shall be validated & documented
by the laboratory performing test 4.3.1

4.4.4
The test method validation shall demonstrate the suitability
of the method as used. Following elements shall be included-
- determination of test method repeatability, reproducibility
- establishment of test method senstivity for integrity tests 4.3.2

4.3.3
4.5
Documentation
Demonstration of conformity with the requirements of this
4.5.1 document shall be recorded 4.4.1

4.5.2 All Records shall be retained for a specified period of time. 4.4.2

Records of conformity with the requirements shall include ,

but is not limited to, performance data, specifications and tet
results from validated test methods, as well as validation
4.5.3 protocols, conclusions and any necessary actions. 4.4.3
 Electronic records, electronic signatures and handwritten
signatures executed to executed to electronic records that
contribute to validation, process control or other quality
decision-making processes shall remain legible, readily
4.5.4 identifiable and retrievable. 4.4.4

Validation of
5 Packaging 5
process
5.1 General 5.1

5.1.1 Preformed sterile barrier system and sterile barrier system 5.1.1
manufacturing process shall be validated
5.1.2 Process validation shall include, at a minimum, an IQ, OQ and
Pq, in this order 5.1.2
the process
- process parameters for control to produce specified output
Process Development is consideredan integral part of 5.1.3
5.1.3 forming and sealing
validation of existing prodcts can rely on data from previous
validations and can be used for determining tolerances for
process parameter 5.1.4

5.1.4 When similar manufacturing processes are validated, a

rationale for establishing similarities and identifying the
worst case configuration shall be documented and validated 5.1.5
5.2 Installation 5.2
Qualification
5.2.1 The IQ Shall be performed , as minimum, all elements to be 5.2.1
listed in the process specification.
5.2.2 Test Shall be performed to confirm that process variables can
be controlled as specified 5.2.2
5.2.3 Funtions that allow process variable monitoring shall be
checked or certified in place 5.2.3

Alarms, warning systems or machine stops shall be

5.2.4 challenged in the event that process variables exceed
predetermined limits 5.2.4
5.2.5 Specified instruments, sensors, displays etc shall be
caliberated and have written caliberation schedules 5.2.5
5.2.6 There shall be written preventive maintenance and cleaning
schedules 5.2.6
5.2.7 The application software systems shall be validated 5.2.7
5.3 Operational 5.3
qualification

5.3.1 Process variables shall be challenged to determine upper and 5.3.1

lower parameter limits that produce packaging system that
meet all predetermined specifications
 As a minimum, preformed sterile barrier systems and sterile
5.3.2 barrier systems shall be produced at both the upper & lower 5.3.2
process limits and exhibit properties that meet the
predefined specifications
5.4 Performance 5.4
Qualification

5.4.1 The PQ shall demonstrate that the process will consistently 5.4.1
produce packaging system that meet predetermined
requirements under anticipated operating conditions

The PQ shall include the following-

-the actual or simulated contents, unless a rationale can be
5.4.2 established that contents are not required 5.4.2
- nominal process parameters established in the OQ
-verification of produc/package requirements
-assurance of process control & capability
- process repeatability & reproducibility
5.4.3 Challenges to the process shall include conditions anticipated 5.4.3
to be encountered during manufacture

5.4.4 The PQ process shall include at least three production runs 5.4.4
to assess repeatability & reproducibility

5.4.5 Documented procedures and/or specifications for various 5.4.5

operations shall be established and incorporated inPQ
5.4.6 5.4.6
Special process variables shall be monitored and recorded

The process shall be under control & capable of consistently

5.4.7 producing products according to predetermined 5.4.7
requirements

5.5 Formal Approval 5.5

of the process
validation

Review and formal approval of the process validation shall be

5.5.1 carried out and documented as a final step in the validation 5.5.1
program

The documentation shall summarize and reference all

5.5.2 protocols & results, and state conclusions regarding the 5.5.2
validation status of the process
5.6 Process control 5.6
& monitoring
 Procedures shall be established, implemented and
5.6.1 maintained to ensure that the packaging process is under 5.6.1
control and within the established parameters during routine
operation and consistently producing the specified process
output
5.6.2 Specified process variables shall be routinely monitored and
records shall be maintained 5.6.2

5.7 Process Changes 5.7

& Revalidation

Proceses concerning forming,assembly etc shallbe covered

5.7.1 by a change-control procedure for documenting, verifying 5.7.1
and authorizing change

5.7.2 Processes shall be revalidated if changes are made to the 5.7.2

equipment, contents, packaging material or packaging
process that compromise the original validation

The need of revalidation shallbe evaluated & documented.

5.7.3 Revalidation does no have to be as extensive as initial 5.7.3
validation
5.7.4 Minor process changes shall be documented and can require 5.7.4
review of validation status

6
Assembly 6

The sterile barrier system shall be assembled under

6.1 appropriate environmental conditions to minimize risk posed 6.1
by contaminants to medical device

The packaging system assembly process shall follow

6.2 controlled labelling and processing procedures to prevent 6.2
mislabelling

6.3 Packaging system shall be assembled and filled according to 6.3

the instructions based on validated process that enables
sterilisation in a defined sterilisation process.

7 Use of reusable In addition to the requirements listed in 6, instrucions and 7

sterile barrier restrictions for use as specified in ISO 11607-1 shall be
system followed

8 Sterile fluid path Assembly of sterile fluid path components and closures shall 8
packaging meet the requirements of clause 5 and 6
7-2: 2019 & ISO 11607-2: 2006
2006

Clause Gap/Description
Scope
Normative
reference
Terms and
Definitions

Expiry date
Installation qualification
Labelling

Operational qualification
Packaging System
Performance qualification
Preformed Sterile Barrier system

Product
Protective packaging
Repeatability
Reproducibility
Reusable container

Sterile barrier system

Sterile fluid path packaging

Validation
Process development- establishing the nominal values and
limit(s) for critical process parameter
General
Requirements
Quality Systems
Activities described in this document shall be carried out
within a formal quality system
It is not necessary to obtain third-party certification of the
QMS to fulfill requirements of this part
Healthcare facilities may use the QMS required by their
country/region

Sampling plan used shall be validated and based upon

Sampling stastically valid rationale
Test Methods
A rationale for selection of appropriate tests for packaging
system shall be established and recorded
A rationale for acceptance criteria shall be established and
recorded
All the test methods used shall be validated & documented
by the laboratory performing test

The test method validation shall demonstrate the

suitability of the method as used. Following elements shall
be included-
- determination of test method repeatability,
reproducibility
- establishment of test method senstivity for integrity tests

Unless otherwise specified in the test methods, test

samples shall be conditioned at (23+- 1Deg Cel) and (50+-
2)% relative humidity for a minimum of 24h.

Demonstration of conformity with the requirements of this

document shall be recorded

All Records shall be retained for a specified period of time.

Records of conformity with the requirements shall include ,

but is not limited to, performance data, specifications and
tet results from validated test methods.
 Electronic records, electronic signatures and handwritten
signatures executed to executed to electronic records that
contribute to validation, process control or other quality
decision-making processes shall be reliable.

Validation of
Packaging process
General
Preformed sterile barrier system and sterile barrier system
manufacturing process shall be validated
Process validation shall include, at a minimum, an IQ, OQ
and Pq, in this order
Process Development is consideredan integral part of
forming and sealing

validation of existing prodcts can rely on data from

previous validations and can be used for determining
tolerances for process parameter

When similar manufacturing processes are validated, a

rationale for establishing similarities and identifying the
worst case configuration shall be documented and
validated
Installation
Qualification

Installation qualification shall be performed

Critical process parameters shall be defined

Critical process parameters shall be controlled and
monitored

Alarms, warning systems or machine stops shall be

challenged in the event that process variables exceed
predetermined limits
Specified instruments, sensors, displays etc shall be
caliberated and have written caliberation schedules
There shall be written preventive maintenance and
cleaning schedules
The application software systems shall be validated
Operational
qualification

Process variables shall be challenged to determine upper

and lower parameter limits that produce packaging system
that meet all predetermined specifications
 As a minimum, preformed sterile barrier systems and
sterile barrier systems shall be produced at both the upper
& lower process limits and exhibit properties that meet the
predefined specifications
Performance
Qualification

The PQ shall demonstrate that the process will consistently

produce packaging system that meet predetermined
requirements under anticipated operating conditions

The PQ shall include the following-

-the actual or simulated contents, unless a rationale can be
established that contents are not required
- nominal process parameters established in the OQ
-verification of produc/package requirements
-assurance of process control & capability
- process repeatability & reproducibility
Challenges to the process shall include conditions
anticipated to be encountered during manufacture

The PQ process shall include at least three production runs

to assess repeatability & reproducibility

Documented procedures and/or specifications for various

operations shall be established and incorporated inPQ

Special process variables shall be monitored and recorded

The process shall be under control & capable of

consistently producing products according to
predetermined requirements

Formal Approval
of the process
validation

Review and formal approval of the process validation shall

be carried out and documented as a final step in the
validation program

The documentation shall summarize and reference all

protocols & results, and state conclusions regarding the
validation status of the process
Process control &
monitoring
 Procedures shall be established, implemented and
maintained to ensure that the packaging process is under
control and within the established parameters during
routine operation and consistently producing the specified
process output
Critical process parameters shall be routinely monitored
and documented

Process Changes &

Revalidation

Proceses concerning forming,assembly etc shallbe covered

by a change-control procedure for documenting, verifying
and authorizing change

Processes shall be revalidated if changes are made to the

equipment, contents, packaging material or packaging
process that compromise the original validation

The need of revalidation shallbe evaluated & documented.

Revalidation does no have to be as extensive as initial
validation
Minor process changes shall be documented and can
require review of validation status

Packaging system
Assembly

The sterile barrier system shall be assembled under

appropriate environmental conditions to minimize risk
posed by contaminants to medical device

The packaging system assembly process shall follow

controlled labelling and processing procedures to prevent
mislabelling

Packaging system shall be assembled and filled according

to the instructions based on validated process that enables
sterilisation in a defined sterilisation process.

Use of reusable In addition to the requirements listed in 6, instrucions and

sterile barrier restrictions for use as specified in ISO 11607-1 shall be
system followed

Sterile fluid path

packaging

Assembly of sterile fluid path components and closures

8.1 shall meet the requirements of clause 5 and 6
 Medical device labelled 'sterile fluid path' shall maintain
sterility of the fluid path by construction of the device in
8.2 combination with its closure