Validation of packaging for the packaging of sterile distro jogja products | Good Practice
Validation is the mechanism used to ensure that any procedure, process, equipment, material, activity or system actually leads to expected distro jogja results (WHO, 2007). It is a documented procedure for obtaining, recording and interpreting the results demonstrate that the process will yield products in accordance with predetermined criteria (ISO 11607-1, 2006). According NOLAN (2004), the validation of packaging for the packaging of sterile medical products must address:
The mentioned points are established in the development phase of the package distro jogja and must be ensured at all stages distro jogja of the manufacturing process. The Handbook of Quality distro jogja Management Systems for Medical Devices of the U.S. Food & Drug Administration - FDA states that vendors can test the materials and provide the manufacturer with a certificate of conformity in accordance with the required specifications, which can be accepted distro jogja as a document in the validation process after qualifying distro jogja the supplier (FDA, 2009). However, the validation of the final package is up to the manufacturer who, in addition to qualifying equipment, distro jogja develop, qualify and monitor distro jogja manufacturing processes (NOLAN, 2004).
Generally there are two types of validation: An evidenced distro jogja by trials distro jogja (prospective validation) and another based on analysis of historical (retrospective validation), however the latter is not applicable distro jogja for sterile products (WHO, 2007). distro jogja The validation of the package involves two distinct aspects: the validation of the developed packaging design and validation of the manufacturing process. The first evidence that the project meets the intended use and the second ensures that the process results in a product that meets specifications (FDA, 2009).
For packagings intended for the packaging distro jogja of sterile products for health, the mechanisms to ensure that the material and / or sterile barrier system present conditions of production compatible with the intended use are contained in ISO 11607-1 (2006) standard Packaging distro jogja for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, which specifies the basic attributes for a wide variety distro jogja of materials and their interaction with medical devices, packaging designs, sterilization methods and forms of distribution; defines the activities to describe the processes used in the manufacture and assembly of the final product, assists in the selection of tests and provides criteria that can be used in the evaluation of the packaging system.
ISO 11607-2 (2006) standard Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes, deals with the validation of the packaging system and provides some examples of processes that must be validated as training and rigid blister sealing, flexible, envelopes and coils; automated processes of formation, filling and sealing etc..
The Guide to Quality Assurance for Pharmaceuticals World Health Organization (WHO) states that validation must have written protocols distro jogja that must contain at least: objectives, responsible and study site; description of default (POPs) procedures to be followed; equipment , standards and criteria for relevant processes and products; kind of validation, processes and / or parameters contemplated; sampling, testing and monitoring requirements, and acceptance criteria for evaluating results (WHO, 2007).
Due to the large number of combinations and the consequent impossibility of evaluating all possibilities, is usually employed distro jogja the concept of worst case (worst distro jogja case), so that the validation process becomes feasible. According to the WHO Guide (2007) the worst case is defined as:
"A condition or set of conditions encompassing upper and lower processing limits for operating parameters and conditions defined in SOPs, which pose the greatest chance of product or process failure when compared to ideal conditions."
The worst case should be determined by the manufacturer taking into account the different applications of the product, size of packaging, sealing area, sort of sealer, sealing conditions etc.. Once set, you must determine which tests will be performed to ensure the manufacturing process of the packaging. ISO 11607-1 (2006) standard distro jogja suggests a number of assays distro jogja that can be used to evaluate the performance of the packaging, including: internal pressure, penetration colored solution, detection of gas leakage, vacuum sealing force, distro jogja simulation transport, microbial barrier.
The World Forum for Hospital Sterile Supply - WFHSS developed a Guideline for Validation of Process Selage
Validation is the mechanism used to ensure that any procedure, process, equipment, material, activity or system actually leads to expected distro jogja results (WHO, 2007). It is a documented procedure for obtaining, recording and interpreting the results demonstrate that the process will yield products in accordance with predetermined criteria (ISO 11607-1, 2006). According NOLAN (2004), the validation of packaging for the packaging of sterile medical products must address:
The mentioned points are established in the development phase of the package distro jogja and must be ensured at all stages distro jogja of the manufacturing process. The Handbook of Quality distro jogja Management Systems for Medical Devices of the U.S. Food & Drug Administration - FDA states that vendors can test the materials and provide the manufacturer with a certificate of conformity in accordance with the required specifications, which can be accepted distro jogja as a document in the validation process after qualifying distro jogja the supplier (FDA, 2009). However, the validation of the final package is up to the manufacturer who, in addition to qualifying equipment, distro jogja develop, qualify and monitor distro jogja manufacturing processes (NOLAN, 2004).
Generally there are two types of validation: An evidenced distro jogja by trials distro jogja (prospective validation) and another based on analysis of historical (retrospective validation), however the latter is not applicable distro jogja for sterile products (WHO, 2007). distro jogja The validation of the package involves two distinct aspects: the validation of the developed packaging design and validation of the manufacturing process. The first evidence that the project meets the intended use and the second ensures that the process results in a product that meets specifications (FDA, 2009).
For packagings intended for the packaging distro jogja of sterile products for health, the mechanisms to ensure that the material and / or sterile barrier system present conditions of production compatible with the intended use are contained in ISO 11607-1 (2006) standard Packaging distro jogja for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, which specifies the basic attributes for a wide variety distro jogja of materials and their interaction with medical devices, packaging designs, sterilization methods and forms of distribution; defines the activities to describe the processes used in the manufacture and assembly of the final product, assists in the selection of tests and provides criteria that can be used in the evaluation of the packaging system.
ISO 11607-2 (2006) standard Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes, deals with the validation of the packaging system and provides some examples of processes that must be validated as training and rigid blister sealing, flexible, envelopes and coils; automated processes of formation, filling and sealing etc..
The Guide to Quality Assurance for Pharmaceuticals World Health Organization (WHO) states that validation must have written protocols distro jogja that must contain at least: objectives, responsible and study site; description of default (POPs) procedures to be followed; equipment , standards and criteria for relevant processes and products; kind of validation, processes and / or parameters contemplated; sampling, testing and monitoring requirements, and acceptance criteria for evaluating results (WHO, 2007).
Due to the large number of combinations and the consequent impossibility of evaluating all possibilities, is usually employed distro jogja the concept of worst case (worst distro jogja case), so that the validation process becomes feasible. According to the WHO Guide (2007) the worst case is defined as:
"A condition or set of conditions encompassing upper and lower processing limits for operating parameters and conditions defined in SOPs, which pose the greatest chance of product or process failure when compared to ideal conditions."
The worst case should be determined by the manufacturer taking into account the different applications of the product, size of packaging, sealing area, sort of sealer, sealing conditions etc.. Once set, you must determine which tests will be performed to ensure the manufacturing process of the packaging. ISO 11607-1 (2006) standard distro jogja suggests a number of assays distro jogja that can be used to evaluate the performance of the packaging, including: internal pressure, penetration colored solution, detection of gas leakage, vacuum sealing force, distro jogja simulation transport, microbial barrier.
The World Forum for Hospital Sterile Supply - WFHSS developed a Guideline for Validation of Process Selage
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