HOW TO VALIDATE PACKAGE SYSTEMS FOR MEDICAL DEVICES

1
A Case Study

• HOW TO VALIDATE PACKAGE SYSTEMS FOR MEDICAL
  DEVICES
• HEALTHPACK 2001
• MARCH 19, 2001

2
PRESENTATION OUTLINE

• Introduction
• Purpose
• Project Scope
• Standard
• Validation Plan
• Package Description
• Material Qualification
• Equipment Qualification
• Sterilization Validation
• Package Design and Development
• Final Package Design Qualification
• Test Methods
• Summary

3
INTRODUCTION

• Package system validation conducted for a
  start-up medical device company.
• Company is ISO 9000 certified
• No packaging design expertise on staff
• Validating the package system was essential for
  successful market introduction of their products.

4
PURPOSE OF PACKAGE VALIDATION

• FDA requires that all processes be validated.
• manufacturer must prove the efficacy of the
  product and package system.
• must ensure the product and package system
  combine to create a total product which performs
  efficiently, safely, and effectively in the hands
  of the user (ISO 11607 Introduction)

5
PROJECT SCOPE

• To provide documentation supporting the final
  package design, engineering, production, and
  distribution environment performance under
  conditions incident to the manufacturing and
  distribution of the product.

6
STANDARD
ANSI/AAMI/ISO 11607 Clause 4Packaging
Materials Clause 5Package forming and
sealing Clause 6Final (product) package
7
THE VALIDATION PLAN

• Package System Validation must include the
  following Qualifications
• Material
• Equipment Installation
• Equipment Performance
• Package Process
• Sterilization Validation
• Package Design and Development
• Final Package

8
PACKAGE DESCRIPTION

• PETG thermoform tray with Tyvek lid.
• Tyvek-to-PE plastic pouch
• Paperboard carton
• Shipping Box
• Detailed material specifications must be
  developed for the DMR.

9
PACKAGE DESCRIPTION
Initial Package Design Configuration
Final shipping configuration
Thermoform tray inserted in Tyvek/poly header bag
10
MATERIAL QUALIFICATION
Clause 4

• Properties, performance attributes, and
  interactions with product materials are well
  known and are developed by vendors.
• Microbial barrier properties of Tyvek is well
  known.
• Compatibility of materials with EtO sterilization
  process is known.
• Materials meet all vendor performance
  specifications.

11
MATERIAL QUALIFICATION

• A Quality System in place to evaluate incoming
  materials for conformance to performance
  specifications.
• Company was ISO 9000 certified.
• Responsibilities
• Company required vendors to certify compliance to
  material specifications
• Company performed incoming quality control of
  materials to verify compliance.

12
STERILIZATION VALIDATION
Clause 4

• Stand alone validation within package system
  validation
• Validate effectiveness of product sterilization
  (e.g. bioburden, biological indicators, sterility
  tests)
• Evaluate condition of packaging materials after
  sterilization

13
EQUIPMENT QUALIFICATION

• Before starting final process development, it
  shall be demonstrated that the process equipment
  and ancillary systems are capable of consistently
  operating within established design and operating
  limits and tolerances.

Clause 5
Example of Blister Sealer
14
EQUIPMENT QUALIFICATION

• Process Development
• establish upper and lower process limits
• compatibility of materials with forming machine.
• Process design--establish machine parameters
• Process Verification--challenge the process limits

15
EQUIPMENT QUALIFICATION

• Process Performance Qualification
• demonstrate effectiveness and reproducibility of
  the process
• document procedures and specification
• document protocols
• Process Control
• ensure that the packaging process is under
  control during routine operation

16
EQUIPMENT QUALIFICATION
17
PACKAGE DESIGN AND DEVELOPMENT
Clause 6

• Packages must be evaluated under conditions
  incident to the normal processing (e.g.
  sterilization), storage, and handling
  environments.
• This can be done effectively through a design
  and development phase.

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PACKAGE DESIGN AND DEVELOPMENT

• Each test selection cannot be considered as a
  stand-alone procedure for final package
  acceptance.
• However, it is often useful to evaluate the
  package system to the inputs from each process
  individually to assess the response.
• So, a package design and development phase may
  circumvent critical problems during final package
  qualification.

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PACKAGE DESIGN AND DEVELOPMENT
Documentation is key...

• So, a protocol is essential to establish the
  plan for this phase of package system validation.

20
PACKAGE DESIGN AND DEVELOPMENT
Test Plan
21
PACKAGE DESIGN AND DEVELOPMENT

• After the testing is completed, a final Test
  Report must be generated to document the test
  results, corrective actions, or other

issues found during this design development phase
of the validation.
22
CORRECTIVE ACTIONS
Initial Package Design
1st Redesign
2nd Redesign
Flow charts show progress for each package design
23
PACKAGE DESIGN AND DEVELOPMENT

• When all corrective actions have been taken and
  re-qualified to the design/development protocol,
  then the final package design qualification can
  be executed.

24
FINAL PACKAGE DESIGN QUALIFICATION

• A protocol must be developed that details the
  test plan and acceptance criteria.
• The protocol must be
• approved by all parties
• This phase incorporates all of the processes
  involved in delivering a product to its end user
  (e.g. sealing, sterilization, shipping, storage,
  etc.)

Clause 6
25
FINAL PACKAGE DESIGN QUALIFICATION
26
TEST PROCEDURE FLOW CHART
27
TEST METHODS
28
TEST METHODS

• Distribution Simulation Testing
• ASTM D 4169
• ISTA

29
FINAL PACKAGE DESIGN QUALIFICATION

• A final Discussion summarizes the Acceptance
  Criteria and Rationale for Acceptance of the
  Validation.

30
FINAL PACKAGE DESIGN QUALIFICATION
31
SUMMARY

• A complete package system validation includes
  the following qualifications
• Equipment Installation
• Equipment Performance
• Package Process
• Sterilization
• Package Performance (optional)
• Final Package Design

32
SUMMARY

• Time to complete a package system validation
  6-9 months
• Cost to complete a package system validation
  10,000-20,000

33
QUESTIONS?