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Standards & Packaging

Standards & Packaging. Implant placed in barrier package  Sterilize  Package provides barrier to microorganisms until use. ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

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Standards & Packaging

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  1. Standards & Packaging Implant placed in barrier package  Sterilize  Package provides barrier to microorganisms until use

  2. ISO 11607-1:2006 • Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems • ISO 11607-2:2006 • Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes • EN 868-1 • Packaging Materials and Systems for Medical Devices which are to be Sterilised • ASTM F2097 • Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

  3. ISO 11607 Packaging for Terminally Sterilised Medical Devices.1,2 • Is the sterile barrier packaging material suitable for the task? • Can it be sealed successfully by the equipment in use? • Has the reliable performance of the sealing equipment been proven? • Does the outer packaging protect the sterile barrier packaging in transit and storage? • Does this protection continue throughout the stated shelf to the point of use?

  4. Blister‑Packaging: • 85% of solid drugs in Europe are packed in blisters • DOT is one of Europe's leading providers of medical coating solutions for orthopedic and dental (Optimised product safety through cleanroom packaging and laser marking) has validated blister-sealing machines for sterile packaging under clean room conditions at her disposal. Products can be boxed and labeled in accordance with individual customer needs.

  5. Pouch Packaging: • validated vacuum- sealing machines are especially designed for sterile packaging of healthcare products under cleanroom conditions. • The products are vacuum packed in PA and PE bags. A protective gas can also be added if desired. The bags can then be boxed and labeled as well. All sealing is subjected to a regular process monitoring. • Self seal& heat seal • Limited size

  6. Pouches are suitable for flat, low bulk products such as dressings, although, many other products are packed this way. • The main requirement is that the product should not be free to move in anyway that could allow it to pierce or damage the packaging materials or seals. Pouch performance in this respect can be improved by immobilising the product, for example by mounting it on a card. • Blister packs are ideal for heavier products or those with edges or corners that may damage the pack if it is jolted. • A typical example is orthopaedic implants, which could gain sufficient momentum to pass through a pack seal. The blister is usually designed to restrain the product and has the added advantages of presenting the product to the user in a desired orientation and giving the impression of high quality.

  7. Non sterile Packaging • The non sterile serial packaging covers the packaging of implants and instruments in PE pouches, including inline printing using any layout desired. Various counts of roll bags can be packaged. These bags can also be supplied perforated, thus allowing for easy separation (an ideal solution for packaging in sets). • Shrink wrapping: • Boxed products can be shrink- wrapped, with tear-open strips if desired.

  8. Implant Packaging Solution • Problem: Multiple-sized spinal implants needed to fit in one package • Solution: A tray that accommodated all spinal implants was designed and produced • Additional Benefits: • Flexibility of package allowed the company to keep their packaging costs down • Streamlined practical use of the product • Increased ease of identification

  9. Can the sterile barrier material be sealed successfully by the equipment in use? • Strength tests such as burst tests, peel tests and for integrity with dye or gas penetration tests. • This is also the time to investigate the robustness of packaging design prototypes with product prototypes. • The integrity of the sterile barrier should be confirmed by simple drop and shaking cycles followed by seal tests. • It is also worth considering initiating some ageing studies.

  10. A Peel test (photo:Mark-10)

  11. ASTM F 2054 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates, www.astm.org/Standards/F2054.htm • ASTM F 1140 Standard Test Method for Burst Testing of Unrestrained Flexible Package Seals Using Internal Air Pressurisation,www.astm.org/Standards/F1140.htm • ASTM F 1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration, www.astm.org/Standards/F1929.htm • ASTM F88/F88M - 09 Standard Test Method for Seal Strength of Flexible Barrier Materials, www.astm.org/Standards/F88.htm • ASTM F 2338 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method, www.astm.org/Standards/F2338.htm

  12. Has the reliable performance of the sealing equipment been proven? • The optimum sealing parameters should be identified. • combination of time, pressure and temperature. All of these parameters combine to regulate the amount of energy that goes into a seal. Once the optimum settings are found an operating window is required. To identify this window, all the parameters must be reduced gradually to establish a lower level that still produces seals of the correct quality, strength and integrity. The process is repeated for high energy settings. In the validation process, seal strength and integrity tests are performed at the upper and lower limits and over three batches at the production (usually optimum) settings.

  13. Does the outer packaging protect the sterile barrier packaging in transit and storage? • Transit testing on the "final" product • However, sometimes a dummy product is used to simulate the shape and mass when product is expensive or not available. The least protected packaging unit should be tested. This is usually the minimum shipping quantity. • The impact and vibration cycles must be followed by sterile barrier integrity checks and this requires that sufficient quantities of product are processed to give statistically significant results. • The storage and shipping environment should be considered in the testing process.

  14. Does this protection continue throughout the stated shelf to the point of use? • Shelf life validation (long time) • The continued function of the product and packaging must be proven at the end of the shelf life. • Accelerated ageing is used to reduce the timescales. • This is enacted by holding the packages at an elevated temperature for an extended period. The most common ageing temperature is 55°C. If used in conjunction with recommended storage conditions of 20-25°C, this delivers one year of accelerated ageing in six weeks. For a five year shelf life that amounts to 30 weeks (in the ageing chamber) with the seal strength and integrity test being performed after this period. One process used to shorten timescales, at least to product launch, is to build up the shelf life by sampling the packs at one year equivalent periods.Again sufficient numbers of tests for statistical significance are required and the use of packages sealed at minimum and maximum energy settings should be considered.

  15. ISO 11607 requires that real-time samples are made and put aside at the same time as accelerated ageing samples are produced.Information on packaging transit testing is found in these standards: • ASTM D4169 -09, Standard Practice for Performance Testing of Shipping Containers and systems, www.astm.org/Standards/D4169.htm • International Safe Transit Association. Procedure 2A: ISTA Preshipment Testing Procedures- Combination Tests for Packaged Products Weighing 150 lb (68 kg) or less, www.ista.org/forms/2Aoverview.pdf • ISO 4180:2009, Packaging - Complete, Filled Transport Packages - General Rules for the Compilation of Performance Test Schedules.

  16. Primary Packaging • ISO 11607 Packaging for terminally sterilized medical devices, parts 1 and 2 • ASTM D3078 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission • ASTM D4991 Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method • ASTM D6653 Standard Test Method for Determining the Affects of High Altitude on Packaging Systems by Vacuum Method • ASTM F88/F88M Standard Test Method for Seal Strength of Flexible Barrier Materials • ASTM F1140 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

  17. ASTM F1585 Standard Guide for Integrity Testing of Porous Barrier Medical Packages1 • ASTM F1886 Standard Test method for Determining Integrity of Seals for Medical Packaging by Visual Inspection • ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration • ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices • ASTM F2054 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization within Restraining Plates • ASTM F2096 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) • ASTM F2338 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method • USP Container closure and elastomeric tests • USP Medicinal container test 

  18. ISO /TC 150 Implants for surgeryCreation date: 1971 Standardization in the field of implants for surgery and their required instrumentation, covering terminology, specifications and methods of tests for all types of implants, and for the materials both basic and composite used in their manufacture and application. 1) Objects or devices which are surgically implanted in the body either temporarily or permanently for diagnostic or therapeutic purposes. Total number of published ISO standards related to the TC and its SCs (number includes updates): 133 Number of published ISO standards under the direct responsibility of TC 150 (number includes updates): 10 Participating countries: 24 Observing countries: 19

  19. TC 150 - Implants for surgery • Subcommittees • TC 150/SC 1 Materials • TC 150/SC 2 Cardiovascular implants and extracorporeal systems • TC 150/SC 3 Neurosurgical implants • TC 150/SC 4 Bone and joint replacements • TC 150/SC 5 Osteosynthesis and spinal devices • TC 150/SC 6 Active implants • TC 150/SC 7 Tissue-engineered medical products

  20. ISO 13779-4 • ISO 13779-4:2002 • Implants for surgery -- Hydroxyapatite -- Part 4: Determination of coating adhesion strengthMore details, Edition 1 • Stage90.60 • TCTC 150/SC 1 • ICS11.040.40 • Document available as of 2002-05-09 • ISO 13779-3:2008 • Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity and phase purityMore details , Edition 1 • Stage90.60 • TCTC 150/SC 1 • ICS11.040.40 • Document available as of 2008-01-31 • ISO 13779-1:2008 • Implants for surgery -- Hydroxyapatite -- Part 1: Ceramic hydroxyapatiteMore details , Edition 2 • Stage90.60 • TCTC 150/SC 1 • ICS11.040.40 • Document available as of 2008-09-17 • ISO 13779-2:2008 • Implants for surgery -- Hydroxyapatite -- Part 2: Coatings of hydroxyapatite, Determination of coating adhesion strength

  21. , BS 8432:2005 gives guidance on the design of spinal orthoses. • BS EN ISO 25539-2:2009 Cardiovascular implants. Endovascular devices. Vascular stents • BS ISO 23317:2007 Implants for surgery. In vitro evaluation for apatite-forming ability of implant materials • BS ISO 13779-1:2008 Implants for surgery. Hydroxyapatite. Ceramic hydroxyapatite • BS ISO 13779-2:2008 Implants for surgery. Hydroxyapatite. Coatings of hydroxyapatite • BS ISO 13779-3:2008 Implants for surgery. Hydroxyapatite. Chemical analysis and characterization of crystallinity and phase purity • BS ISO 5832-1:2007 Implants for surgery. Metallic materials. Wrought stainless steel • BS ISO 29781:2008 Prostheses and orthoses. Factors to be included when describing physical activity of a person who has had a lower limb • BS ISO 29782:2008 Prostheses and orthoses. Factors to be considered when specifying a prosthesis for a person who has had a lower limb • BS ISO 29783-1:2008 Prosthetics and orthotics. Vocabulary. Normal gait • BS ISO 7206-1:2008 Implants for surgery. Partial and total hip joint prostheses. Classification and designation of dimensions

  22. ISO 13779-3:2008 • Abstract • specifies methods of test for the chemical analysis and assessment of crystallinity and phase composition of hydroxyapatite-based materials such as coatings and sintered products • استاندارد ملی ایران 1-13705 • بسته بندی نهایی وسایل پزشکی سترون شده: قسمت 1: الزامات مواد، سیستم های حافظ سترونی و سیستم های بسته بندی

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