• Aseptic Presentation: Transfer of sterile contents from its sterile barrier system using conditions and procedures that minimize the risk of microbial contamination
  • Bioburden: Population of viable microorganisms on or in product and/or sterile barrier system
  • CAPA : Corrective Action/Preventive Action
  • Closure: Means used to complete a sterile barrier system where no seal is formed
  • Closure Integrity: Characteristics of a closure to minimize the risk of ingress of microorganisms
  • Control: Regulation of variables within specified limits
  • Corrective Action: Action taken to eliminate an existing nonconformity to prevent reoccurence
  • Defensible Test: Utilizing objective evidence to make a claim
  • Design Input: The physical and performane requirements of a device that are used as a basis for device design
  • Design Output: Results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.
  • Design Review: A documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems
  • Device Master Record (DMR): A compiliation of records containing the production history of a finished device
  • DOE (Design of Experiments): Planning, conducting, analyzing, interpreting, controlled tests to evaluate the factors that control the value of the parameter or a group of parameters
  • EUMDR: European Union Medical Device Regulation
  • expiry date: Date by which product should be used
  • Finished Device: Any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized
  • FMEA: Failure Mode Effect Analysis
  • Gap Analysis: Ensuring product conformance to new or updated regulations
  • Installation Qualification (IQ): Process of establishing by objective evidence that all key aspects of the process equipment and ancillary
    system installation comply with the approved specification
  • ISO 11607 Part 1: Packaging for terminally sterilized medical devices- Requirements for materials, sterile barrier systems and packaging systems
  • ISO 11607 Part 2: Packaging for terminally sterilized medical devices- Validation requirements for forming, sealing and assembly processes
  • Labeling: Label, instructions for use and any other information that is related to identification, technical description, intended purpose and proper use of the health care product, but excluding shipping documents
  • Lot: One or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits
  • Master Validation Plan: Outlines the principles involved in the qualification of a facility or process, defining the areas and systems to be validated, and provides a written program for achieving and maintaining a qualified facility or process
  • Medical Device: Instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
    — diagnosis, prevention, monitoring, treatment or alleviation of disease;
    — diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
    — investigation, replacement, modification, or support of the anatomy or of a physiological process;
    — supporting or sustaining life;
    — control of conception;
    — disinfection of medical devices;
    — providing information by means of in vitro examination of specimens derived from the human body;
    and does not achieve its primary intended action by pharmacological, immunological or metabolic
    means, in or on the human body, but which may be assisted in its intended function by such means
  • Microbial Barrier: Property of a sterile barrier system to minimize the risk of ingress of microorganisms
  • Monitoring: Continual checking, supervising, critically observing, or determining the status, in order to identify change from the performance level required or expected
  • Nonconformity: The nonfulfillment of a specified requirement
  • Notified Body: An organization that has been designated by a member state (of the EU) to assess the conformity of certain products with the applicable essential technical requirements
  • Operational Qualification (OQ): Process of obtaining and documenting evidence that installed equipment operates within predetermined
    limits when used in accordance with its operational procedures
  • Package Design: Packaging is the science, art, and technology of enclosing or protecting product for distribution, storage, sale, and use
  • Packaging System: Combination of a sterile barrier system and protective packaging
  • Performance Qualification (PQ): Process of establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements
  • Performance Testing: The process of evaluating the quality or capability of a product
  • Preformed Sterile Barrier system: Sterile barrier system that is supplied partially assembled for filling and final closure or sealing
  • Preventive Action: Actions taken to eliminate a potential nonconformity or to prevent an occurrence
  • Primary Packaging: Packaging in direct contact with the product itself
  • Process Parameter: Specified value for a process variable
  • Process Specification: Documented procedure that includes all equipment, process parameters, monitors and materials
    required to manufacture a product that consistently meets requirements
  • Process Variable: Chemical or physical attribute within a cleaning, disinfection, packaging or sterilization process,
    changes in which can alter its effectiveness
  • Product: Tangible result of a process
  • Protective Packaging: Configuration of materials designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use
  • Remediation: The process of improving or correcting a situation
  • Repeatability : Condition of measurement, out of a set of conditions that includes the same measurement procedure, same operators, same measuring system, same operating conditions and same location, and replicate measurements on the same or similar objects over a short period of time
  • Reproducibility: Condition of measurement, out of a set of conditions that includes different locations, processors, measuring systems, and replicate measurements on the same or similar objects
  • Reusable Container: Rigid sterile barrier system designed to be used repeatedly
  • Root Cause Analysis: Method of problem solving used to identify root causes
  • Seal: Result of joining surfaces together by fusion to form a microbial barrier
  • Seal Integrity: Characteristics of a seal to minimize the ingress of microorganisms
  • Seal Strength: Mechanical capacity of the seal to withstand force
  • Secondary Packaging: Packaging that holds together individual products
  • Service Life: Number of processing cycles and/or lifetime up to which a product is claimed to remain suitable and safe for its intended use when used according to the labelling
  • SOP: Standard Operating Procedure
  • Specification: Any requirement with which a product, process, service, or other activity must conform
  • Stability Testing: Evaluation of how a product maintains integrity over its life span
  • Sterile: Free from viable microorganisms
  • Sterile Barrier System (SBS): Minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation of the sterile contents at the point of use
  • Sterile Fluid-Path Packaging: System of protective port covers and/or packaging designed to ensure sterility of the portion of the medical device intended for contact with fluids
  • Sterilization Compatibility: Attributes of the packaging material and/or system that allow it both to withstand the sterilization process and attain the required conditions for sterilization within the packaging system
  • Sterilizing Agent: Physical or chemical entity, or combination of entities, having sufficient microbiocidal activity to achieve sterility under specified conditions
  • Terminal Sterilization: Process whereby a product is sterilized within its sterile barrier system
  • Terminally Sterilized: Condition of a product that has been exposed to a sterilization process in its sterile barrier system
  • Tertiary Packaging: Packaging that is used to protect not only the product but also its secondary and primary packaging
  • Test Method Validation: Demonstrate the suitability of the method used, including repeatability, reproducibility, and sensitivity
  • Use By Date/Shelf Life: Upper limit of the time interval during which the performance characteristics of a material and/or preformed sterile barrier system, stored under the specified conditions, have been demonstrated
  • User Needs: Qualities or characteristics meaningful to the customer
  • Validation: Confirmation process, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled
  • Verification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

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