1March 3-5, 2009www.healthpack.net

Case Study in Test Method Validation - ASTM F1886 (2004),

Visual Examination

Todd Dehmer CPPSenior Packaging Engineer

St. Jude Medical, AFD Division

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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 ValidationTest 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 ValidationTest 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.

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Process for ValidationCreate 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 dataTrays

–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 dataPouches

–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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