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QUALITY

MEDICAL DEVICE PACKAGING REQUIREMENTS FOR QUALITY CERTIFICATION OF MEDICAL DEVICES


Mr. Sanjay Shah
Quality System Consultant for Medical Devices

MEDICAL DEVICE - DEFINITION 

‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: 

¨ diagnosis, prevention, monitoring, treatment Or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means ¨ 

¨ active implantable devices covered by Directive 90/385/EEC 

INTRODUCTION 

PACKAGING - Basic Requirements 

The medical device packing should 

  • prevent damage during shipment and storage of Medical Components and Devices 

IMPORTANCE OF MEDICAL DEVICE PACKAGING 

  • To comply with current FDA Quality Systems Good Manufacturing Practices (GMP)

  • European Medical Device Directives & EN Standards 

  • ISO 14000 and other international standards and requirements 

REQUIREMENTS FOR COMPLIANCE 

COMPLIANCE TO IS, ISO, EN (EUROPEAN NORMS), US FDA STANDARDS 

Standards ISO 9001 and EN ISO 13485 & EN 980 

  • The quality system requirements for the design, development, production, installation, and servicing of healthcare products, specifically Medical Devices 

  • EN : 980 Labeling 

  • EN : 980 - Graphical Symbols For Use in The Labeling of Medical Devices 

  • EN : 556 - Requirements for Medical Devices to be Designated “Sterile” 

REQUIREMENTS FOR PACKAGING

  • Sterile Barrier Package Integrity 

  • Materials Specifications 

  • Industry Benchmarking 

  • Labeling 

  • Materials Data Base

NEED FOR INNOVATION 

International and domestic regulatory requirements are added periodically 

  • new sterilization methods appear 

  • packaging materials change 

  • new standards are written 

  • packaging and bar-coding equipment becomes more sophisticated and concern for the environment increases 

Medical Device Packaging Materials  

  • Medical-grade Papers, Non-Wovens, Tyvek Grades 

  • Film and Sheet 

  • Monolayer Films, Coextruded Films, Monolayer Sheet, Foils 

  • Sealants for Medical Device Packaging 

  • Seal Performance Requirements 

  • Other Medical Device Packaging Materials 

  • Lidding Materials 

  • High Barrier Materials 

  • Multi-layer Films 

  • Porous Films 

  • Formable Foils 

  • Non-coated Systems 

  • New Sealant Developments 

VARIOUS STERILIZATION METHODS 

Steam under Pressure 

  • Temperature: 121-132ºC 

  • Pressure: 15-19 lbs/inch2 (gauge) 

  • Exposure time: 5-45 minutes 

  • Sterilization by steam under pressure is a relatively simple process 

Ethylene Oxide

  • Temperature: 25-75ºC 

  • Pressure: subatmospheric to 1.3 Kg/cm2 or 25 lbs/in2 (gauge) 

  • Gas concentration: 450-1000 mg/L 

  • Relative Humidity: 50-80% 

  • Exposure time: 1-12 hours 

  • involves exposure to dry saturated steam at the desired temperature and pressure 

Radiation (Co-60, Cs-137, accelerated electrons) 

  • Dose: 1.5-3.5 Mrad 

  • Radiation sterilization, either by gamma rays from Co-60 or Cs-137 

  • radioisotopes, or accelerated electrons, offers a simple sterilization 

  • alternative for moisture sensitive / thermolabile non-liquid products 

Asceptic Processing 

  • Many liquid pharmaceutical and biological products cannot withstand any form of thermal sterilization so aseptic technique 

  • filtration and then filled into pre sterilized containers in a clean room environment 

  • Aseptic filtration-passing the solution through a sterile 0.1 to 0.22 mm microbiological filter 

  • Emerging Sterilization Processes 

  • Hydrogen Peroxide Gas Plasma 

  • Flash Sterilization 

  • Alternative Gases 

  • Pulsed Light 

  • Continuous Process 

Characterization of Materials 

  • Chemical, physical and biological characterization of raw materials or components: 

  • Establish material fitness for intended use 

  • Develop material specification 

  • Ensure material consistency from lot to lot 

  • Reduce reliance on biological testing 

  • Identify unacceptable materials 

Biocompatibility of Materials 

  • Evaluation of biocompatibility appropriate for the intended use 

  • Provide support for regulatory approval submission

  • Evaluate components or product biocompatibility 

  • Ensure product safety and suitability

  • Meet ISO 10993 standards

  • Full range of in vivo and in vitro testing 

Product and Process Validation 

  • Aims at demonstrating that manufacturing process controls are sufficient for pre-production QA requirements and product specifications. 

  • Environmental control 

  • Establish manufacturing process control 

  • Sterility tests 

  • Qualification of finished product 

Audit and Release Testing 

  • Tests to qualify regulatory requirements for a finished product prior to its release into the market and on a batch-to-batch or periodic basis to assure uniformity and compliance with product claims and quality systems regulations 

  • Fulfil requirements for sale 

  • Verify conformity to specifications 

  • Conduct periodic audit testing 

VALIDATION OF PACKAGING MATERIAL DEFINITIONS

  • Verification - Objective evidence that requirements have been fulfilled. Performed through inspection or measurement

  • Validation - Objective evidence that a material consistently produces a result that meets specification. Performed by using packaging material at different conditions keeping in mind requirements for Device Packed 

ETHYLENE OXIDE  

  • Efficacy to kill is measured in Sterility Assurance Levels (SALs) 

  • for Ethylene Oxide it is 10-6 or 99.9999% 

  • To test efficacy, a highly resistant Bacillus Subtilis is used to challenge each sterilization load 

  • Because it is imperative that the EtO penetrates the packaging and contacts all surfaces of the item, Biological indicators impregnated with B Subtilis are placed in each load 

DETERMINING THE APPROPRIATE MICROBIAL CHALLENGE 

  • A biological indicator (BI) is an “inoculated carrier contained within its primary pack providing a known resistance to the relevant process” 

DETERMINING THE APPROPRIATE PRODUCT LOAD CHALLENGE  

  • Microbiological performance qualification (MPQ) should be performed using specified products and packaging configured in the same manner in which they will be routinely sterilized.***
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