Case Study in Test Method
Validation - ASTM F1886 (2004),
Visual Examination
Todd Dehmer CPP
Senior Packaging Engineer
Presentation Overview
•
Visual Inspection Usage
•
ASTM F1886 Overview
•
Reason for Validation
•
Process for Validation
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.
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
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.
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.
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
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.
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.
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.
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.
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.
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
Process for Validation
Test Prerequisites - continued
• Have properly installed, calibrated, andmaintained 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.
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
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)
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)
Process for Validation
•
Sampling Plan
–Document quantity to be tested for each category (0.003”, 0.005”, & “no defect” negative controls)
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)
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)
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
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…
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
Process for Validation
•
Getting started – follow thru with your
Validation plan… - continued
–Document your Package Sample Defect & Identification Key
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).
Process for Validation
• Sample Preparation
Process for Validation
• Sample Preparation
– Follow your Identification Key and label sample appropriately.
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.
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
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
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
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.
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.
Thank You
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