Case Study in Test Method

Validation - ASTM F1886 (2004),

Visual Examination

Todd Dehmer CPP

Senior Packaging Engineer
St. Jude Medical, AFD Division

March 3-5, 2009

www.healthpack.net 1
 Presentation Overview

•Visual Inspection Usage

•ASTM F1886 Overview
•Reason for Validation
•Process for Validation
•On-going Validation

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 Visual Inspection Usage
•Many Medical Device Manufactures are
referencing ASTM F1886 as the visual inspection
method they use to verify the sterile barrier
integrity of their packaging.
•Are the MDM’s referencing this Standard
accurately?
•As specified per ASTM F1886:
–Should be validated to meet the precision
and bias of ASTM F1886.
–Should be validated in accordance with
AAMI/ANSI/ISO 11607-1:2006 and -2:2006?
• Work within your own quality department to determine
applicability.

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 Background
• Per ISO 11607 Part 1:

• 4.4 Test Methods

• 4.4.1 All test methods used to show compliance with this part of ISO
11607 shall be validated and documented.
NOTE Annex B contains a list of suitable test methods (such as ASTM F1886).
• 4.4.2 The test method validation shall demonstrate the suitability of
the method used. The following elements shall be included:
– establishment of a rationale for the selection of the appropriate
test for the packaging system;
– establishment of acceptance criteria;
NOTE Pass/fail is a type of criteria;
– determination of test method repeatability;
– determination of test method reproducibility; and
– establishment of test method sensitivity for integrity tests.

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 ASTM F1886 Overview
Scope:
• To determine channels in a package
seal down to a width of 75μm (0.003
in.) with a 60-100% probability.

• To visually detect channel defects

applicable to flexible and rigid
packages with at least one
transparent side.

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ASTM F1886-04 Overview
Summary:
• To provide a qualitative visual
inspection method to evaluate the
appearance characteristics of
unopened, intact seals in order to
determine the presence of defects
that may affect the integrity of the
package.

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ASTM F1886-04 Overview
Significance and Use
• Seal attributes can be linked directly
to a number of variables in process
parameters, equipment, or material,
as well as environmental.

• Visual seal characteristics and

defects can provide evidence of
sterile package integriy and
production sealing problems.
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ASTM F1886-04 Overview
Lighting and Procedure
• Lighting arrangements to give
approximately 540 lumens/m2 (50fc)
of white light or daylight.

• Visual acuity shall be such that the

inspection of the seal may be
performed at a distance of 12 to 18
in.

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 ASTM F1886 Overview
Precision and Bias
• A round robin study was conducted
for ASTM F 1886.

• The internal test method should be

shown to be equivalent to or better
than ASTM F 1886 round robin
results to differentiate acceptable
package seals from specific types of
defects.

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 ASTM F1886 Overview
Precision and Bias - continued
• To accomplish this, samples with the
same defect categories as those
documented in the ASTM method can be
produced as well as a quantity of negative
control samples with no channels.

• The defect categories used were 0.003”

(75μm) channel leaks and 0.005” (125μm)
channel leaks.
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When would this method be used?
• As an internal method to validate SBS
sealing processes and new SBS
configurations.

• As an internal method to evaluate SBS

after package performance testing.

• As a process monitoring/control tool.

• Evaluating seal integrity after an aging

study on an SBS.
Note: ASTM F1886 is an FDA Recognized Consensus Standard

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 Need for Validation
Why is it necessary to validate
this test?
• Requirement per ISO 11607
• Current internal visual inspection
method may not have provided any
formal training or attempt to
validate.
• Provides better packaging quality.

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 Process for Validation
Test Prerequisites
• Acquire 0.003” & 0.005” diameter wire to
create channel defects.
• Determine sample category to use for
validation (such as pouches or sealed
trays).
• Sample has to have one transparent
side.
• Determine quantity of each sample
category to use during validation (this can
be based on internal statistical
requirements and significance).
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 Process for Validation
Test Prerequisites - continued
• Have properly installed, calibrated, and
maintained sealing equipment (bar
sealers/tray sealers).
• Confirm lighting requirements are met per
ASTM F1886 where the internal visual
inspection of defects will be performed
(measure via a light meter or similar
device).
• Determine who will be assembling the
samples.
• Determine who will be examining the
samples. 14
 Process for Validation
Create a test method validation plan to
include:
– Plan information
– Plan approvals
– Test Method Data
– Validation Planning
– Validation Targets
– Sampling Plan
– Preparation Records
– Training, Examination and Data Collection Plan
– Analyze the data and prepare a Validation Report
– Approval Section

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 Process for Validation
• Plan information
– Internal document number/identification/revision

• Plan approvals
– Author(s) of Validation Plan and others (such as
quality representative) per your internal requirements

• Test Method Data

– Test method description (Documented Visual
Inspection procedure of pouch seals or tray seals)
– Test method identification (ASTM F 1886)

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 Process for Validation
• Validation Planning
–The scope/purpose of the validation
–Description of what your trying to accomplish

• Validation Targets
–Repeatability
–Reproducibility
–Validation (target of what needs to be met to
conform to ASTM F 1886)

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 Process for Validation

• Sampling Plan
–Document quantity to be tested for each
category (0.003”, 0.005”, & “no defect”
negative controls)

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 Process for Validation

• Preparation Records
–Sample numbering (what labeling/marking
method to use to determine which samples
have certain channel sizes and no defect
samples)
–Equipment
–Equipment settings (process number and
revision)
–Environmental Conditions during assembly

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 Process for Validation
• Preparation Records - continued
–Tooling (as required)
–Part and lot numbers of the SBS components
used to assemble the samples
–Person(s) assembling the samples
–Date parts were assembled
–Person pre-judging the parts (if
applicable/required)

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 Process for Validation
• Training, Examination and Data
Collection Plan
–Instruction provided to examiners (such as a
review of ASTM F 1886) and existing internal
visual inspection procedure
–Data Collection Plan
–Administering the examinations

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 Process for Validation
• Analyze the data and prepare a
Validation Report
– Organize and analyze the data collected from
the examination
– Make determination of the validation status
based upon the data
– Document the results in a Validation Report
including all applicable data

After a Validation Plan is complete its time to

get started…

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 Process for Validation
• Getting started – follow thru with
your Validation plan…
– Document your equipment used (internal designation
or otherwise, calibration date, etc.)
– Confirm equipment settings meet internal
manufacturing process requirements
– Document environmental conditions during assembly
– Tooling used
– Document part numbers, lot information, etc.
– Person(s) assembling the samples
– Date of assembly
– Person pre-judging the parts (if applicable)

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 Process for Validation
• Getting started – follow thru with your
Validation plan… - continued
–Document your Package Sample
Defect & Identification Key

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 Process for Validation
• Prepare samples per validation plan
• Sample Preparation
– Randomly place the wire between the location to be sealed to
create the defect (channel).

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 Process for Validation
• Sample Preparation
– Example photo of how defect areas were designated.

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 Process for Validation
• Sample Preparation
– Follow your Identification Key and label sample appropriately.

– Depending on your sample category (trays, pouches, etc) you

will seal up samples for the 0.003”, 0.005”, and no defect.
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Administer Visual Examinations
• Perform visual examination (confirm
adequate lighting per ASTM F 1886)
–When successfully completed it
will provide evidence that an
operator can perform the visual
inspection and will be considered
a validated operator.

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 Analyze the data
• Based on the results, the
personnel who examined the
samples should demonstrate
the ability to repeat the results
of the round robin study done
by ASTM

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 Analyze the data
Trays
–Personnel who examined tray/lid
samples should have identified 98% of
no defects or better.
–Personnel who examined defects of
the 0.003” channels should have
determined there to be defects 60% of
the time.
–Personnel who examined defects of
the 0.005” channels should have
determine there to be defects 83% of
the time.
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 Analyze the data
Pouches
–Personnel who examined pouch
samples should have identified 97% of
no defects or better.
–Personnel who examined defects of
the 0.003” channels should have
determined there to be defects 69% of
the time.
–Personnel who examined defects of
the 0.005” channels should have
determine there to be defects 96% of
the time.
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 Internal visual inspection
This presentation walked through the
validation process for ASTM F1886.
This standard can be used for the following
and are examples:
– Manufacturing Procedure
– Workmanship Specification

Work within your own quality department to

determine applicability.

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 References
- ASTM F1886-98(2004); Standard Test Method for
Determining Integrity of Seals for Medical Packaging
by Visual Inspection.

- ANSI/AAMI/ISO 11607-1:2006; Packaging for

terminally sterilized medical devices – Part 1:
Requirements for materials, sterile barrier systems,
and packaging systems.

- ANSI/AAMI/ISO 11607-2:2006; Packaging for

terminally sterilized medical devices – Part 2:
Validation requirements for forming, sealing, and
assembly processes.

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Thank You

Questions?

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