patient safety: medical device distribution evaluation and ... · patient safety: medical device...

Patient Safety: Medical

Device Distribution

Evaluation and Sterile Barrier

System Integrity

Jan Gates, VP Client Solutions, Adept Packaging

Jane Severin, VP Technical Solutions, Network Partners

ASTM Work Shop , 11 October 2017

2ASTM D10 and F02 Workshop, October 2017

OBJECTIVE

Present information on package distribution simulation and

sterile barrier integrity testing

Describe ASTM tests to assist in meeting regulatory and

standards requirements


3ASTM D10 and F02 Workshop, October 2017ASTM D10 and F02 Workshop, October 2017

DISCLAIMER

These slides

are our

opinions,

based on our

60+ years’

experience,

and not

necessarily the

opinion of the

companies we

represent.


AGENDA

ISO 11607-1/-2 Overview

ISO 11607-1/-2 Design and Validation Specifics

• Design and validations

• General requirements

• Process validations

• Packaging validations

• Test methods validations

• Microbial/whole package integrity

• Microbial testing

• Integrity Testing

Shipping and Important Considerations

The Last 1000 Feet

Proposals

ASTM D10 and F02 Workshop, October 20174


Packaging For Terminally Sterilized

Medical Devices —

Part 1: Requirements for Materials, Sterile Barrier

Systems and Packaging Systems

Part 2: Validation Requirements for Forming,

Sealing and Assembly Processes


ISO 11607-1/-2 STANDARDS


ISO 11607-1/-2 STANDARDS

Outlines the packaging design, development and testing

Over 150 “shall” statements in the two documents

FDA harmonized with the standard in November 2006



ISO 11607-1/-2 VALIDATION SPECIFICS

Validating a sterile barrier system involves four different types of

validation activities:

• Design

• Packaging Process

• Sterilization

• Test Methods



ISO 11607-1 DESIGN

Design

• 6.1.1 The Packaging System shall be designed to minimize the

safety hazard to the user and patient under the intended specified

conditions of use.

Accomplished with the use of risk assessment and mitigation

techniques-output examples: Component and Process

Specifications, process knowledge, user needs, etc.

Develop pre-determined requirements for the design

Validation provides objective evidence that the requirements have

been met; ‘design outputs = design inputs’



ISO 11607-1 DESIGN VALIDATION

Design Validation <definition>

3.28 validation

• (general) confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled.

Consists of two elements - Industry practice to conduct these tests as independent studies

• Package Performance Testing - A physical evaluation to demonstrate that the packaging system is adequate to protect the product throughout distribution, handling and storage

• Stability Testing - A chemical and physical evaluation to demonstrate that the SBS maintains integrity over time. Basis for expiry claims.



TRANSPORTATION

Will your design survive?

Copyright © 2013 DuPont.


DESIGN AND VALIDATION ARE KEY…

Examples of sterile packaging failures:

Seal Creep Seal Failure Transport Damage



ISO 11607-2 PROCESS VALIDATION

Process Validation <definition>

• 3.16 validation (process) documented procedure for obtaining,

recording and interpreting the results required to establish that a

process will consistently yield product complying with predetermined

specifications.

Provide documented, objective evidence that the packaging

process is in statistical control, is repeatable, and makes product

that meets predetermined specifications.


• IQ Installation Qualification - Verify equipment is correctly

installed and functional, including all high and low settings

• OQ Operational Qualification - Defined process window

(seal)

• PQ Performance Qualification - Adequate process control

and capability


13

PACKAGING SYSTEM QUALIFICATIONS


EN ISO 11607:2006 - SECTIONS 1 TO 4

General Requirements

Test Methods

• All test methods, including non-standardised ones, shall be validated and documented

• Note: ISO 11607-1, Annex B contains a list of suitable test methods

Test method validation shall include

• Rational for selection of appropriate tests

• Establishment of acceptance criteria

• Determination of repeatability (r)

• Determination of reproducibility (R)

• Establishment of sensitivity for integrity tests

Needs interlaboratory check and comparison with published test method r & R



PACKAGE VALIDATION - ISO 11607-1:2006

➢ 5.2.3: Porous materials shall provide an adequate microbial barrier to microorganisms in order to provide integrity of the sterile barrier system and product safety.

➢ 6.3 Packaging-system performance testing

➢ 6.3.1 Integrity of the sterile barrier system shall be demonstrated after

sterilization and subsequent performance testing.

➢ 6.3.2 Physical tests, along with microbial barrier testing of porous

packaging materials, can be used to establish the capability of the

sterile barrier system to maintain sterility.

➢ 6.3.3 In the absence of applicable validated tests (for the complete

package), microbial barrier performance requirements can be

established by testing:

➢ The microbial barrier properties of materials

➢ The integrity of seals and closures



TWO FUNDAMENTAL QUESTIONS

Why is Microbial Barrier Important?

• The key factor in selecting packaging materials for medical

devices is the ability of the package to maintain sterility

from the point of sterilization until it is opened for use

➢ Why is Microbial Barrier Testing Important?

• Need to understand how the packaging material will perform

as a microbial barrier during handling, distribution and

storage; post sterilization



MICROBIAL BARRIER TESTING

Traditional Whole Package Microbial Challenge

• HIMA Study comparing whole package test and physical tests

o Dye and Visual

o Found a significant difference; Whole Package Challenge found to be unreliable

and fraught with false-positives

o Hansen, J; Jones, L. et al (1995) In Quest of Sterile Packaging; Part 1 Approach

to Package Testing MDDI 17(8) 56-61

• Current practice is to use material microbial testing for porous substrates and physical testing for finished packages

o ASTM F1608-16 Standard Test Method for Microbial Ranking of Porous Packaging

Materials (Exposure Chamber Method)

o ASTM F2638-12 Standard Test Method for Using Aerosol Filtration for Measuring the

Performance of Porous Packaging Materials as a Surrogate Microbial Barrier


PACKAGE INTEGRITY TEST METHODS

ASTM F1886 Standard Test Method for Determining Integrity of

Seals for Medical Packaging by Visual Inspection

• 75 micron (60-100% Probability)

ASTM F2096 Standard Test Method for Detecting Gross Leaks in

Medical Packaging by Internal Pressurization (Bubble Leak Test)

• Sensitivity Down to 250 micron

ASTM F1929 Standard Test Method for Detecting Seal Leaks in

Porous Medical Packaging by Dye Penetration

• Sensitivity Down to 50 micron



SENSITIVITIES

ASTM

Test

Type of Test Test Focus Destructive

?

Hole/ Channel

Size

F1886 Visual Inspection Seals No 75 μm

F1929 Dye Penetration Seals Yes 50 μm

F2096 Internal

Pressurization

bubble test

Package Yes 250 μm

F2228 CO2 tracer gas Package

(porous area

masked)

No 50-l00 μm

F2338 Vacuum Decay Package

(porous area

masked)

No 100-125 μm

F3004 Airborne

Ultrasound

Seals No Depending on

defect type

(750 μm)



SHIPPING AND IMPORTANT

CONSIDERATIONS



CALCULATING DIM

L= length

W = width

H = height

DIM = (L x W x H)/DIM ratio by carrier



PALLET/BOX STRENGTH CALCULATIONS



SIMULATED DISTRIBUTION TESTING

ISTA 3A, 3B, and 3E are FDA Consensus Standards (2016)

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/results.cfm



SIMULATED DISTRIBUTION TESTING ASTM D4169 and D7386 FDA Recognized for many years

Common Usage

Assurance Levels – I and II used

Standard Distribution Cycle

Use

ASTM D4169 DC 4 Single package with pallet or skid, LTL motor

freight

ASTM D4169 DC 13 Air (intercity) and motor freight (local, single

package up to 150 lb. (61.8 kg).

ASTM D4169 DC 2 Specially defined distribution system, user

specified

ASTM D7386 Not

applicable*

Single parcel carrier shipments



HEALTHPACK LIVE POLLING 2017



ORIGINAL DISTRIBUTION CONSIDERATIONS

UseHospital

Manufacturer

Manufacturer

Manufacturer


ASTM D4169 – may have trucks, planes or trains in the transit

ASTM D7386 – single parcel shipment added

Plane Transit


MORE CURRENT DISTRIBUTION LANE

UseHospital

Manufacturer

Manufacturer

ManufacturerHome

Product

Trunk StockWhere does trunk stock occur?


ASTM D4169 or D7386? More discussion later.


CASE FILL

Full case of one product?

Mixed product loads?

Full pallet loads?

Potential to bulk ship to one location

(distributor) then individually or small

quantity ship to another location

(customer)?

Last mile issues


MIXED LOAD SHIPPING


ONE SIMPLE U.S. DISTRIBUTION LANE

Ship to hubTransfer/sorting hub

FlyStack in tarmacLoad plane

Ship to airport Unload truckLoad truck

Unload planeStack in tarmac

Unload truck

Load truckShip to customer

Customer unloads shipper Prep product for use

Use



DISTRIBUTION MAPPING –DETAILED MULTIPLE SHIPPING COUNT EXAMPLE

Domestic System and Domestic Repetition

Round trip Handling Truck Transit Plane Transit Compression

1 23 6 1 3

2 47 13 3 7

3 71 20 5 11

4 95 27 7 15

5 119 34 9 19

6 143 41 11 23

International System and International Repetition

Round trip Handling Truck Transit Plane Transit Compression

1 37 10 3 7

2 77 21 7 15

3 124 32 11 23

4 171 43 15 31

5 218 54 19 39

6 265 65 23 47



3

2


LAST 1000 FEET/LAST MILE

► Unexpected situations occurring

before use

UseHospital



HEALTHCARE ASSOCIATED INFECTIONS

► CDC reports that the causal agent is not known for roughly 30% of HAIs in the US

► Could packaging materials be a contributor?

► What are the elements that medical devicepackaging are exposed to that could impact thebarrier?

► Do you know what your product is exposed to inhealthcare facilities once removed from shipping container?

► How do current test methods for microbial barrier provide meaningful data?

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PROPOSALS1. Last 1000 feet investigation work group developed?

• Important for us to collaborate closely with healthcare

• Should an new work group be developed in ASTM for

this work?

• Task force formed to evaluate whole package

microbial testing?

2. Mixed load work group, D10.21.05

• Currently being developed as an ‘e-commence’ work

group and subsections are possible

• Add drone shipping to the schedules?

3. Volunteers?

• Let us know…..



QUESTIONS?



CONTACTS

Jan GatesVice President, Client Solutions

Phone/Cell: 650.743.5780

E-mail: [email protected]

Website: www.adeptpackaging.com

Jane Severin, PhD, CPPVice President, Technical SolutionsPhone/Cell: 248.408.0127

E-mail:

[email protected]

Website: www.networkpartners.com

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