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Sterile Barrier System (SBS) validation
With the recent release of ISO 11607 parts 1 and 2 there has been increased interest in topics related to global medical packaging compliance. A robust understanding of the basic aspects of a thorough Sterile Barrier System (SBS) validation program is instrumental to ensuring product efficacy and ultimately, patient safety.
The newly revised ISO 11607 documents establish better-defined terminology to help reduce confusion. Using the new terms will help medical device manufacturers (MDMs) more effectively communicate with suppliers, regulatory bodies, and each other. The new terms for consideration are listed below:
- Sterile Barrier System (SBS)—minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at point of use
- Preformed Sterile Barrier System (PSBS)—sterile barrier system that is supplied partially assembled, for filling and final closure or sealing
- Protective Packaging—configuration of materials designed to prevent damage to the sterile barrier system (SBS) and its contents from the time of assembly to the point of use
- Packaging System—combination of the sterile barrier system (SBS) and protective packaging
When developing a validation program for medical packaging, MDMs should first understand the reason for and objective of a "validation." The validation evaluation of a packaging system should prove that device packaging and shipping containers are constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution. MDMs can demonstrate compliance by following the guidelines ("shall" statements) included in ISO 11607 parts 1 and part 2.
The word "validation" is the most overused and misused term in medical packaging technology today. There are numerous definitions for validation including specific information related to general validation verses process validation. In the author's opinion, validation of a packaging system is the culmination of numerous tasks, processes, and events which demonstrate the ability of the sterile barrier system to ensure sterility maintenance and device effectiveness throughout the package lifecycle.
The chart below illustrates some of the necessary steps and stage gates for adequately validating a package system and the manufacturing processes required to produce it. The level of detail and steps required can vary from company to company based on a specific organization's approach to risk management.
Step ONE—The design input stage includes the collection of various design requirements needed to adequately understand the lifecycle of a packaged device. Design inputs should include device attribute requirements, protection requirements, sterilization processes, intended shelf life, sales unit configuration, and the mode(s) of distribution, to name a few.
Step TWO—The material selection and evaluation phase should include a review of the design inputs for consideration of specific material attributes. Various material attributes that should be considered include (but aren't limited to): sterilization, safety, barrier properties, visibility and appearance, durability, heat sealability, processing and printability, and manufacturability/availability.
Step THREE—Package system development is a multiphase process that includes design of the sterile barrier system as well as the overall protective packaging portion to make up the entire packaging system. This process should be well-documented following an established procedure to ensure the design output meets the requirements of the design inputs. Design of the SBS based on inputs and process capabilities should start as early in the product development project as possible. The protective packaging materials and design should be considered to determine how robust the SBS must be to maintain sterility.
Step FOUR—The package process feasibility phase includes considerations for the following areas: process risk analysis (FMEA, FTA, etc.), projected volumes, equipment capabilities, target cost for the total package system, and development of flowcharts and SOPs to facilitate fabricating, product loading, sealing, and packing.
Step FIVE—Sterile barrier system design feasibility can often be conducted in conjunction with phase six as an initial pass/fail test. This phase is nothing more than verifying the probability of success for a specified package system. The test samples should be exposed to dynamic testing to verify whether the SBS can withstand the hazards of the potentially rigorous distribution environment.
Step SIX—Validation of sterile barrier system manufacturing process includes the steps taken at the packaging material suppliers and the MDM that validate the manufacturing processes (i.e. sealing, coating, etc.), ensuring consistently reliable product each and every time. Sterile packaging manufacturers are responsible for validating their processes. MDMs are responsible for the closure seal applied in their operation to the SBS or PSBS. This phase should be conducted in accordance with the readily available guidance related to validation. The process should include, at a minimum, a well-documented installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Step SEVEN—The final packaging system design validation phase entails the actual functional testing phase of the packaging system. Investing sufficient time and effort in the first six steps can eliminate the need to invest significant package development time and money during this final validation phase. Often referred to as the "shake and bake" testing simulation, this method of testing often includes an evaluation of seal strength and seal (and/or whole package) integrity following exposure to distribution, aging, and the applicable sterilization process (not necessarily in that order).
The testing phase should be conducted on predetermined worst case scenarios to allow for grouping of products and packaging systems into product family categories. The determination (i.e. definition) of worst case can and should be defined by the MDM in terms of the many factors that could include (but are not limited to): sterile barrier system manufacturing parameters, sterilization method (including cycles, parameters, number of exposures), shipping configuration, distribution environment/mode, shelf life expectations, and specific product-related attributes.
Step EIGHT—Packaging system and manufacturing process revalidation is commonly overlooked by MDMs as development projects are completed and resource focus is redirected towards new initiatives. MDMs should use a formal risk analysis decision tree to review significant changes to product family, equipment, and critical packaging material or processes, and determine whether revalidation should be conducted.
A well-considered and planned approach to packaging system validation can reduce time and costs associated to bringing medical device products to market. A project of this magnitude should be well-documented to provide evidence of work for future inspections and review as required by notified bodies and government agencies.
References
21 CFR Part 820
FDA QSR Manual
AAMI/ANSI/ISO 11607-1
AAMI/ANSIISO 11607-2
EN 868 Series (part 2-10)
About the author
Randy Troutman is Oliver Medical's technical director. He is a member of the Institute of Packaging Professionals medical device packaging committee and the Association for the Advancement of Medical Instrumentation (AAMI) packaging working group ISO/TC 198. Troutman joined Oliver in 2006, having worked previously for Smith & Nephew, Medtronic, and Kimberly Clark.
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