Some standard content:
RCs11.080
National Standard of the People's Republic of China
GB/T19633--2005/IS011607:2003 Packaging for terminally sterilized medical devices(ISO 11507.2C03,IDT)
2005-01-24 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Administration of Standardization of the People's Republic of China
2005-05-01 Implementation
GB/T19633-2005/IS011607:2003 This standard is equivalent to ISO 11637:2003 Packaging for terminally sterilized medical devices. This standard adopts the international standard 13150: which was first issued in 195. This version is based on the European EN868-1c Recommended for medical devices - Packaging materials and systems - Part 1: Requirements and tests 3. In 18011607-2003, any clauses that differ from EN858-1 are explained in the form of annotations. This standard ensures that these are correct. The appendix to this standard is the normative requirements and the appendix () is the whole material. This standard is proposed by the National Food and Drug Administration. This standard is jointly initiated by the State Food and Drug Administration, Jinan Medical Device Product Quality Supervision and Inspection Center and the main units of this standard: Shandong Medical Device Production Center. The participating units of this standard: China Cunbang Group Co., Ltd., Shandong Chemical Paper Co., Ltd., and Shandong Guanghua Pharmaceutical Packaging Inspection Co., Ltd.
The main drafters of this standard are Guan Ban, Er Wei, Yong Yan, Leng Liping, and Chen Jiang. Scope
GH/T19533—2005/15011607.2003 Packaging of terminally sterilized medical devices
1.1 This standard specifies the requirements for packaging of final medical devices (either disposable or reclosable devices produced in a final manufacturing plant or in other medical institutions (see Section 6). 1.2 This standard outlines the requirements for the development and validation of packaging for terminally sterilized medical devices. Section 7: The molding process is considered to be the most critical process, but other processes may have an impact on the final packaging, not necessarily. This international standard provides guidance for the most common operating and technical requirements. 3 This standard specifies the basic requirements for the packaging of medical devices (see Chapter 7). Its purpose is to provide a comprehensive test and evaluation framework for the protection of medical devices and their components. 1.4 This standard does not cover the packaging of products produced under normal conditions. In these cases, there should be additional requirements to ensure that the color and packaging process will not form a source of product heat. 1.5 This standard does not include the determination of the number or duration of sample or parallel test groups. Design: Do not standardize the medical equipment of hospitals or other institutions, 2 normative reference documents || tt || The following clauses are recorded in this standard through the introduction of the market standard. All referenced documents with a noted date, including the memory of the error) or the repair board after that shall not apply the following standards. However, the parties who have not reached the research and development level of this standard can use the most recent version of these documents. The latest version of the reference document is suitable for this standard, G8/F5402: 1986 Paper and board gas determination (medium range) Part 5, when the prohibition 1ley) # (15056365.M0D)
G8282.12523 Health care products chemical index Part 1, General d011101: 193 Terms and definitions
F series and language research definitions are suitable for this standard,
Bioburden hinbnrlen
The number of viable microorganisms on a certain target. 3.2
Closed closne
The method of forming a seal is used for packaging. For example, folding five times to form a curved road. 3. 3
Closure integrity clasure (ntegril
The use of a sealing member can ensure that the sealing member has at least the same structure as other parts of the packaging to the extent that it can survive the microbial infection. In addition to the EB6M-1 concept,
Suitability assessment compliance compliance is the surface evidence that the packaging meets the final microbiological requirements of the device after inspection according to the method specified in the material specification. 1
0BT19633-2005/5)116072003
Development derelopment
The process of modifying the original design or process to achieve a product that meets the product standard. 3. 6
Failure
The event that one or more parts of the packaging fail to function within the specified limits under specified conditions. 3.
Failure Analysis
To infer and inspect the failure of a product, and analyze the potential failure and the potential of the failure that has already occurred, and try to find out the consequences. 3.8
Final Packaging The final packaging system (excluding the packaging box and transportation container) is designed to ensure that the product can be restored to the original quality level at the time of use.
Reference packaging plan 3.18
4, the quality level can be evaluated again: for physical, chemical and environmental protection, the user can use the screen 2: [S69-1 to evaluate the "packaging flow". The technical evaluation system used in E808-1 is the same as that used in E808-1. Labeling system Inbelinhystem The package label may provide any information (including information contained in or attached to the final package). 3.10 Manufacturer The person or supplier of the medical device packaging and/or the medical device packaging, whether individual or group: 3.11 Medical device The medical device is specially designed or primarily designed by the manufacturer to be one of the following: day and other forms and human, whether used alone or in combination, including the use of any device, equipment, appliance, machine or other replacement products: including use. These days after: disease diagnosis, prevention, monitoring, treatment of cases; diagnosis of injuries. Monitoring of treatment or compensation: research, replacement or repair of structure or life process, control of pregnancy:
its intended effect on or on the human body is not pharmacological, immune, metabolic or welding, there may be these methods and the same effect
microbial barrier mkerubial barrier
The ability of a public packaging system to prevent human movement under specified conditions: 8681 includes
parkaeintegrity
The state of a package that is not physically restrained.
pnckegeconyutibility
packaging adaptability
packaging materials and/or systems 4 do not produce harmful reactions to medical devices under the premise of meeting the requirements of the previous cloud, 2
packaging materials packagemalerial
The right to use in the manufacture or design of packaging materials for the initial packaging 3.16
packaging system packagesystem
GB/T 19633—20CE/[SO 11E0/:2003 white and or a combination of various packaging materials into an independent detailed unit, using ten parts to reduce the total package, 3. 17
Performance qualification performanceqnalification report The quality of the packaging materials tested in accordance with the applicable requirements of the standard, and the packaging meets the requirements of the whole packaging. 3.18
primapackage
A medical device that is contained in a sealed or closed packaging system with a microbial barrier. 3. *9
Producer. pruductr
The natural or legal person, individual or group responsible for the production of the packaging material and/or the system. 3.20
Product
The combination of the medical device and the components and the packaging. 3.21
Qualification
The quality of all specified design and performance requirements are met; 3.22
Revalidation: Revalidation The documented procedure for reconfirming the established validation: 3.23
Seal
The result of pressing between packaging layers:
: close bonding or heat,
seal integrity sealntegrlty
sealing condition ensures that the sealing condition has less micro-material thickness on the packaging: in NT, it defines the difference between the sealing strength
seal si1ength
the average mechanical strength
no slerile
the active micro-material
Note: FN&! 3.27 Sterile finite path packaging The medical device is designed to be in contact with the main components and/or components of the packaging. 3.28 Bacterial compatibility Sleriizntion imppatibility The characteristics of the packaging materials and/or systems that can withstand the sterilization process and reach the conditions required for sterilization in the packaging. 3.29 Terminal sterilization Tennluasteriized Medical devices are sterilized in a sealed container at least in the initial packaging. 3.30 User User The natural person or legal person, individual organization, who is responsible for the use of the product. 331
Confirmation
Through classification, record and analyze the results required by the engineer to demonstrate that a process can produce a product that meets the requirements of the two complete specifications and form a documented process product.
Permit: A partner believes that the whole process of the package is based on the "written method, the design indicators and the visual inspection specification of the equipment, the equipment can operate within the specified range under the specified working conditions, the new process test is carried out through the new level of adjustment, and the performance is guaranteed (performance is guaranteed). 4 General requirements
4.1 Quality assurance
This standard describes the operation of a correct quality system. Note: The requirements of the "1" standard are not consistent with the requirements of the actual standards, and the third party certification is required.
": The sample is a product that is compatible with our quality system. 4.2 Sampling
The selection and measurement of material structure and/or cumulative average inhibition of the sample should be made by the manufacturer and The manufacturer shall agree with the manufacturer, such as the adjustable quality level (AQL) or economical size control (51C) in accordance with GB/T2828 or GB/T1.50. For each selected test method, it shall be described in the form of a support.
2.3 Test method
4.3. "All test methods used to demonstrate compliance with this standard shall be confirmed. The test method must be selected based on the principle, the parameters to be measured and the acceptance criteria shall be formed into a complete part,
4.3.2 For some variations, there are currently acceptable standard test methods in practice. Use these methods. If other methods are used, they shall be confirmed and documented.
Unless otherwise specified in the vehicle test method: The test sample shall be adjusted in accordance with the method in (23 and (the corresponding state shall be selected.
Submission, special N shall be used to complete For the requirements of FN-119
Note 2, the other test methods in Appendix B and C of this sample do not exclude the need for confirmation. Do not rank other recognized methods of testing and performance verification. 4.1 The manufacturer is responsible for ensuring that the entire packaging is properly certified: 1, 4, 2 The manufacturer has the responsibility to conduct qualified testing on the materials. 4.4.3 The manufacturer is responsible for the performance verification: 4.5 Documentation
All steps and results used to confirm that the requirements of this standard are met shall be documented and carried out in accordance with a specified time. 1
GB/T19633-2005/IS>11E07:2003 Series Top Bao Lang Wu A willing time , the length of the verification period depends on many factors and limits, such as the validity period of the packaging materials and/or components, traceability testing, etc.,
Note that the packaging materials and/or components must be transported with the required medical equipment at the same time (Chapter 8). 5.1 General requirements
5.1.1 The purpose of terminal sterilization of medical packaging is to ensure that the product can be kept sterile during its intended life, transport and storage. The type of packaging materials and/or components must be confirmed, and the production, storage, transportation and handling conditions, and deformation standards of the packaging materials and/or components must be controlled to ensure that: These cases are consistent with the use of the packaging materials and/or components: - The characteristics of the packaging materials and/or components must be maintained within the specified pressure range +
—The maximum change in the packaging surface must be within the specified pressure range! When necessary): UV-free
Cleanliness:
Bio-load,
Note: Please consider the efficiency of the packaging rack and/or system when determining the internal sterilization process. 5.1.2 The same pump material can be used as the calibration material for the production of packaging materials. The material is recycled and has a history of moisture dissipation. We can control the energy consumption of the whole product to meet the requirements of the standard,
, and make the industrial production technology, except for the three materials in the production, it is impossible to control the safety of the packaging and the packaging equipment for the treatment of the waste. 5.1.3 The materials should be evaluated for the packaging equipment such as the process of processing. This should also include the impact of this process, this standard policy. In order to provide a relevant performance standard, 5.1.4: The following properties of the material should be evaluated in accordance with the method agreed upon by the manufacturer and the holder: a) Biological barrier properties: h! Toxicological properties;
Physical and chemical resistance:
d) The materials used should only be suitable for:
and the plasticizer should be suitable for the storage limit of the packaging material after the use of the material. f
5.1.5 For other packaging of short-term sterilized medical devices, the basic requirements of 5.1.5 to F.2.9 should be considered: the manufacturer should determine the necessary material properties according to each good application. If the material has the characteristics not listed in Chapter 1, it can be used. The properties listed in Chapter 1 can be used. 5.1.6 General packaging materials, such as packaging materials, single materials, or non-recognizable high-density polyethylene (H[>PE), should meet the following special requirements. The material should not be mixed with the release of substances and foreign substances that may affect its performance and safety. For the field of medical devices and intelligence, there are also certain adverse effects:
The material should have small cracks, cracks, wrinkles or uneven thickness that affect the kinetic energy of the material, and the quality should be consistent with the nominal quality of the producer;
The material should have acceptable cleanliness: the minimum physical properties should be established. Medical devices, -
The packaging and packaging process also require the most complete packaging standards! E
GB/T19633—2005/ISO11607;2003 should set up chemical properties, such as the content of chlorine, to determine the requirements of the medical device packaging process
Name: Under the conditions of use, whether before, after or after sterilization, other packaging materials and systems should not release substances that are sufficient to damage the product:
Second, for this purpose, it is recommended that there is sufficient evidence that the packaging structure or the product will not release neutral substances in the health-related layer. If necessary, the biocompatibility of the packaging material/or system should be evaluated as much as possible in the environment of the medical device. h)
, the phase diagram of the product should be natural. 14/116%.1<111G9-, 5.1.7
In addition to the requirements listed in product 1, the new product should also meet The following requirements are required: the coating should be free of any gaps or cracks to avoid the formation of gaps in the sealing area: a. The coating should be consistent with the manufacturer's label; b. The material specifications of the small seal should be confirmed: 5.1.8 The type and packaging should meet the following requirements: before, during and after sterilization, the material, bonding agent layer, printing layer and chemical indicators should not come into contact with the product and contaminate the product. In addition to meeting the requirements given in 5.1. and 1.?, the forming packaging (paper heat treatment and packaging) should also meet the following requirements: 1. The packaging quality should meet the technical specifications of the whole seal width, expansion slope and or height of the packaging: 2. The printing process of the small object in the packaging should meet the requirements of B1.8.(150111401): 3
Only the scientific and technical book can be opened, and the material should not be exposed to the third layer without affecting the atmosphere.
Jiang: In general, the heat-resistant packaging has a simple and comprehensive performance. The structure and packaging of the packaging should be changed. In addition to the requirements given in 5.1. and 5.1. as applicable, the following requirements should be met:) Each container should have an indication of the use system, when the combination is complete, the oil supply should be clearly indicated: b
In the exhibition from the south, the new and strong parts should have a micro-blue dance barrier (see 5.1.4). Thank you for your quick/willingness. 21! Specified biological barrier; the structure of the container should be easy to inspect all basic components. Before re-use, the manufacturer should specify the following:
) The manufacturer should specify the service cleaning and replacement methods of the equipment. 5.2 Confirmation requirements
2.2.1 The packaging materials and systems shall meet the following requirements for the sterilization process adaptation. 5.2.1.1 It shall be ensured that the specified materials in routine production are within the specified limits for light sterilization. 5.2.1.2 In special cases where multiple sterilization cycles are required, the performance of the packaging materials shall be evaluated to ensure that the performance of the materials is still within the current limits. This shall be determined by the manufacturer.
5.2.1.3 The determination of the properties under the specified conditions shall include the changes in the materials during the supply period. If the product is packaged in multiple layers, different limits shall be agreed upon for the properties of the outer packaging materials. The determination of suitability can be carried out at the same time as the validation of the sterilization process to be used. Material testing should evaluate basic changes such as the degree of mechanical deformation and/or pore size of the material. Will it have an impact on the material properties? 5.2.1.4 It should be demonstrated that the packaging materials and/or system are suitable for the specified sterilization process (such as extinguishing gases, steam, and air). It is also necessary to verify that the packaging materials and/or system have good air and flame penetration under the specified maximum load mode to achieve the required system performance and that the product is fully discharged after extinguishing. In addition, during the sterilization process, the dynamic characteristics of the rod surface should not change to have an impact on the production process: the standard should be adjusted according to the relevant European Cup (N25N55F552FN554 and V1122) to increase the normalizing self-adaptation bottom. These European and American standards are not in production. CB/I'9633-2005/ISO11607-20035.2.1.5 The organic normalizing process is also improved or when it is indeed the first process to use the sterilization process, there is no heat to the packaging materials and/or The manufacturer shall determine the suitability of the packaging materials and/or components with the medical device they contain, including the limits of the physical characteristics of the medical device, such as the stresses it will experience during subsequent operation and storage in a fire. 6) Factors to be considered include:
1) The shape and shape of the medical device to be packaged, 2) There are sharp edges or protruding objects;
The special protection needs of medical devices or their supplies:
Special risks caused by the extreme sensitivity of medical devices (radiation, moisture, electrical shock, etc.) : 1
Juice: For the use of packaging materials and/or the use of materials with the right to use the machine or system, the manufacturer and the industry should ensure that the materials used in the packaging are suitable for the specified materials and the packaging process will not affect the compatibility and effectiveness of the medical device. 5. 2.3 The label system should meet the following requirements. Label system library:
) The color material rate/reduction system and the source of the use of fire and the adverse effect of the self-adaptability: ) "will not be difficult to recognize due to the use of the decision-making guide: will not cause the market to lead to the main medical account being transferred to the packaging material and/or the system to cause damage to the packaging material and/or the system to cause the ink to be printed or the surface to be integrated, and the connection system should be able to withstand the original storage and transportation conditions. ：
生, run the whole process, for example, press the print or gas and in the creation of the package plan long movement/or make the night, happy Sichuan rush to grab the stacking report or the head of the world when the special product is pasted on the dry package material board basebzxz.net
3.2.4 The following requirements of microbial properties should be met. The microbial barrier properties of packaging materials are very important to ensure the integrity of the package and the state of the product: the detailed microbial barrier properties can be divided into the method of applicable non-permeable materials and the method of porous materials. The material should not be transparent. The materials should meet the requirements of microbial barrier properties: 1) The porous materials can provide suitable microbial barriers to ensure the integrity of the flow and the safety of the product, especially the packaging. Note: The porous materials must be properly tested for the speed of flow through the film, or the microbial characteristics of the film must be sufficient to ensure the safety of the product. The products must be tested under the conditions of E-glass, E-glass, etc. Under this established system conditions, the materials must be carefully controlled and the original materials must be reviewed by the doctors at the time of the initial examination. The three points can be related to the non-scientific nature of the other 4 items. 2) The manufacturer must consider the determination of the suitability of the sterile packaging for the intended use. 3) The manufacturer must determine the effectiveness of the drug packaging and determine whether it cannot meet the requirements of the scientific design environment: the microbial barrier test method should meet the following requirements: The steps should be formulated as a set, and the determination of microbial The biological world speaks of the ability to identify the characteristics of biological stimulation. Once the method is proven to be able to identify the characteristics of the material, it must be in the national pharmacopoeia and national standards. Jiang 1: Or three biological test methods have been used to study the economic code. When an acceptable national method is issued,
Jiang: The result will be confirmed sooner than the recognized method. The physical stimulation method can be used to assist the test of the barrier properties.
Note 3: If there is a confirmation that the material is finalized (certificate, the dust concentration of the device is >), then it will be considered to be included in the non-standard version and in the non-standard version.
CB/T19633-2C05/ISO11607:2003 Note 1: The standard is not adopted in accordance with EN8681. The material development and testing method is the same as that of EN8681. See FN831-1107, 1.25.3 Storage and transportation
5.3.1 In the specified conditions (such as During storage and handling, the packaging of hazardous materials and/or systems should provide the necessary protection to maintain their properties.
5.3.2 Since the packaging materials may deteriorate during the process, the manufacturer shall ensure that the properties of the packaging materials are maintained within the specified limits (see 5.1 and 3.3) by one of the following two methods: a) ensuring that these properties are maintained under the storage system specified by the manufacturer; or) ensuring that the extended storage conditions are maintained within the specified limits. These limits and conditions are determined by the manufacturer. 5.4.1 The design of the packaging materials and/or systems should minimize the risk of safety hazards to the intended user under the specified use conditions. 5.4.2 The design of the entire packaging should at least take into account the following points: Compatibility of the packaging materials and/or systems with the intended medical device, that is, the packaging is suitable for the medical device or the medical device is not suitable for the packaging (see 5.2.2); c) The packaging materials and/or systems must be compatible with the intended use (see 3.2.); d) The packaging materials and/or systems must be compatible with the intended use (see 3.2.1); e) The packaging materials and/or systems must be compatible with the intended use (see 3.2.2); f) The packaging materials and/or systems must be compatible with the intended use (see 3.2.3); g) The packaging materials and/or systems must be compatible with the intended use (see 3.2.3); g) The packaging materials and/or systems must be compatible with the intended use (see 3.2.3); g) The packaging materials and/or systems must be compatible with the intended use (see 3.2.3); g) The packaging materials and/or systems must be compatible with the intended use (see 3.2.3); g) The packaging materials and/or systems must be compatible with the intended use (see 3.2.3); g) The packaging materials and/or systems must be compatible with the intended use (see 3.2.3); g) The packaging materials and/or systems must be compatible with the intended use (see 3.2.3); The evaluation requirements of the packaging proposal are also listed. 6 Packaging forming and sealing
5.1 Equipment verification
Before starting or starting a complex process, it should be confirmed that the equipment and auxiliary equipment are operating within the specified design and operating limits:
a) The ability to monitor relevant parameters:
b) Written procedures and calibration (rliidalihraticr) for all instruments, sensors, displays and control terminals, etc.
) Reduction of the shape, seal or other related systems, and the formation of documents (.1 soldiers): d) Maintenance plan and cleaning procedures:
Software confirmation (if applicable)
The maintenance personnel should be trained.
6.2 Process development
62.1. The manufacturing process should be evaluated, and the upper and lower limits of the manufacturing process should be met. Before the materials are selected, the requirements of Chapter 5 of the standard should be changed, and the packaging should be identified whether it meets the requirements of Chapter 5 and the predetermined specifications. E.2.2 The following material suitability requirements apply: a) The manufacturer has the responsibility to ensure that all forming and packaging processes conform to the specified requirements and specifications (including the requirements in Chapter 1); b) The manufacturer has the responsibility to evaluate the ability to consistently produce materials that meet the design requirements; c) There will be differences between batches of material that are not specified, but these may affect the quality of the packaging produced. The manufacturer should take these differences into account when issuing the final packaging. 6.2.3 The following design requirements apply: 1) The material properties should be evaluated to determine which properties have an impact on the final packaging; h) The basic process parameters should be reviewed, which include, but are not limited to: 1) Force/space, including rate of change; 2) Workpiece retention time (line speed); 3) Maximum capacity/frequency/production rate); 4) Torque limit of the closure system. GB/T 19633-2J05/I5 11607:2003,) This basic technical cost should be able to produce a final package that meets the predetermined design specifications. It is recommended to conduct a packaging failure analysis to derive the operating process conditions that do not meet the specifications. This analysis ensures that the upper and lower limits of the operating process are away from critical and failure conditions. 6.2.4 Special process validation requirements apply: 1) Process validation should be carried out during the process and assembly process: upper! The packaging should be produced within the upper and lower limits of the yield, and the final packaging should be prepared appropriately <see Chapter 7) Sustainability: The following characteristics should be considered: 1) For forming and assembly: 1) For forming and assembly: 2) For forming and assembly: 3) For forming and assembly: 4) For forming and assembly: 5) For forming and assembly: 6) For forming and assembly: 7) For forming and assembly: 8) For forming and assembly: 9) For forming and assembly: 10) For forming and assembly: 11) For forming and assembly: 12) For forming and assembly: 13) For forming and assembly: 14) For forming and assembly: 15) For forming and assembly: 16) For forming and assembly: 17) For forming and assembly: 18) For forming and assembly: 19) For forming and assembly: 20) For forming and assembly: 21) For forming and assembly: 22) For forming and assembly: 23) For forming and assembly: 24) For forming and assembly: 25) For forming and assembly: 26) For forming and assembly: 27) For forming and assembly: 28) For forming and assembly: 29) For forming and assembly: 30) For forming and assembly: 31) For forming and assembly: 32) For forming and assembly: 33) For forming and assembly: 34) For forming and assembly: 35) For forming and assembly: 36) For forming and assembly: 37) For forming and assembly: 38) For forming and assembly: 39)
) For livestock:
--complete description of the sealing width;
perforation or gradual opening;
--material separation or separation
--through or open case through the village.
3) For other combined systems:
--closed:
. Perforation or gradual opening:
The material will be divided into islands and merchants
The physical performance test of the packaging produced under the process upper limit or over-position or under the condition of quantity damage should be carried out on the packaging 7.5):
E.3 Process performance appraisal
6.3.1 The difference in performance should be determined under the specified operating conditions for a production process to be adjusted, and the effectiveness of the process should be confirmed.
Design, development and support for accurate performance setting 6.3.2 Documented procedures and specifications for the rate control requirements of packaging operations shall be established and incorporated into the process performance assessment. For visual inspection and recording, this should include: 1) machine procedures:
6 effective test methods for sealing and family process parameters such as accuracy, pressure, torque and retention time, including design and maintenance: d) process parameters such as tightness, end selection and integrity, etc. d) process self-assembly procedures.
6.3.3 The appropriate number of test samples specified in the documented product case shall be repeated to achieve the reproducibility of the same effective cycle. Basic process changes shall be visually and documented. 6.4 Process Control
6.4,1 After the process is confirmed, the responsible person shall establish a procedure to ensure that the packaging process is under normal control. 6.4.2 The responsible person shall fully verify and document the control methods. E.,3 Process documentation of packaging and packaging design. The selection of packaging materials shall be carried out according to the procedures for the formation, approval and approval of changes in the process documentation:
CB/T 19633—2D05/ISO 11607:2DC36.5 Process Certification and Reconfirmation
65,1 As the last step of this confirmation procedure, the process is completed! This review and approval does not represent the meaning of the relevant documents. The following key points should be included in the technical summary:
AL The total station for completing the development and/or identification work; h) Find technical data and/or reference materials with design significance: ., Discussion of major problems and corrective measures taken to solve the problems, 6.3, 2 Initial confirmation of the plan and the effectiveness of the safety and uniformity of the equipment and output value, packaging materials or packaging. If there is any change that may affect the safety of the device during the initial confirmation and the effectiveness of the plan, the plan should be reconfirmed: 7 Final (product) packaging
7.1 Test selection and sampling
7.1.1 The manufacturer shall select the sampling plan for the test group based on the manufacturer's requirements such as AQL.P() and document the selection and inspection procedures. 7.1.2 Each test selection for the final package acceptance cannot be considered as a separate procedure. All tests should be considered comprehensively to ensure that the assembly system is confirmed:
Note: Additional tests may be required for special requirements (such as small parts of the machine). 7.13 When the test package is not assembled on a confirmed production line, the assembly system and process used should be as close as possible to the expected production conditions:
7.2 Visual inspection of the integrity of the sterile package
7.7.1 Visual inspection of packaging integrity 7.2.1 The inspection shall be conducted by a visual inspection person or a regular visual inspection person under the specified conditions of use, location, light source, time and (if necessary) conditions.
7.2.1.2 The manufacturer shall classify the defects found and specify the measures to be taken if any defects are found during normal production operation.
1.2.2 Inspection method
7.2.2. 7.2.2.2 For the packaging of openable components, the following defects should be inspected: a) Irregularity of sterile barrier materials, cracks, fissures, holes or broken parts; 3) There are foreign substances: ||tt| ... 7.3 Tightness/closure evaluation 7.3.1 According to 7.3.2 to 7, the closure of the sample shall be evaluated. 7.3.2 The sealing performance shall be verified by material testing to confirm the sealing performance and continuity of the sample. The microbial barrier test (5, 1.4) of the material shall be conducted to test the integrity of the aseptic packaging component. 7.3.3 There are some requirements on the elasticity of the seal. 1.3.3.1 The sealing process shall be completed within the specified range. The sealing strength shall be determined at the lower limit of the compensation parameter. 1. The sealing process shall be completed within the specified range. Confirm whether it meets the expected value. Note: The average sealing value is the evaluation method for the tightness.4. Specific process validation requirements apply:
) Process validation should be carried out during processing and assembly: upper! Packaging should be carried out within the upper and lower limits of production, and the final packaging should be prepared appropriately <see Chapter 7) Sustainability: The following characteristics should be considered:
1) For forming and assembly:
-: Packaging reduction/packaging complete;
The product is packed in the packaging is
a size that meets
.
) For livestock:
- Complete description of the sealing width;
Perforation or gradual opening;
- Material separation or separation
- A through-hole or opening case.
3) For other integrated systems:
A continuous gap is closed:
. A perforated or gradually opened:
The material will be divided into islands and islands.
The physical performance test of the packaging produced under the process upper limit or over-setting or under the condition of quantity damage should be carried out on the packaging. 7.5):
E.3 Process performance appraisal
6.3.1 The performance difference should be determined by adjusting the production process under the specified operating conditions. The effectiveness of the process should be verified.
Design, process development and support for accurate performance adjustment 6.3.2 The documented procedures and specifications for the rate control requirements of the packaging operation should be established and integrated into the process performance appraisal. The system should include: 1) machine procedures:
6 effective test methods for the quality of the package such as tightness, pressure, torque and retention time, including design and maintenance:
7 effective test methods for the quality of the package such as tightness, selection and integrity, d) process self-contained procedures.
6.3.3 The appropriate number of test samples specified in the documented product case shall be repeated for each run to achieve the reproducibility of the effective run. The basic process changes should be observed and documented. 6.4 Process Control
6.4, 1 After the process is confirmed, the manufacturer shall establish a procedure to ensure that the packaging process is under normal control. 6.4.2 The manufacturer shall fully verify and establish the control method for the obstruction. E., 3 Packaging and density process documents · The selection of packaging materials should be carried out according to the formation, certification and approval change procedures of the situation documents:
CB/T 19633-2D05/ISO 11607:2DC36.5 Process certification and reconfirmation
65, 1 as the last step of this confirmation procedure, pass! This review and approval does not represent the meaning of the relevant documents. The following key points should be included in the technical summary:
AL The total station for completing the development and/or identification work; h) Find technical data and/or reference materials with design significance: ., Discussion of major problems and corrective measures taken to solve the problems, 6.3, 2 Initial confirmation of the plan and the effectiveness of the safety and uniformity of the equipment and output value, packaging materials or packaging. If there is any change that may affect the safety of the device during the initial confirmation and the effectiveness of the plan, the plan should be reconfirmed: 7 Final (product) packaging
7.1 Test selection and sampling
7.1.1 The manufacturer shall select the sampling plan for the test group based on the manufacturer's requirements such as AQL.P() and document the selection and inspection procedures. 7.1.2 Each test selection for the final package acceptance cannot be considered as a separate procedure. All tests should be considered comprehensively to ensure that the assembly system is confirmed:
Note: Additional tests may be required for special requirements (such as small parts of the machine). 7.13 When the test package is not assembled on a confirmed production line, the assembly system and process used should be as close as possible to the expected production conditions:
7.2 Visual inspection of the integrity of the sterile package
7.7.1 Visual inspection of packaging integrity 7.2.1 The inspection shall be conducted by a visual inspection person or a regular visual inspection person under the specified conditions of use, location, light source, time and (if necessary) conditions.
7.2.1.2 The manufacturer shall classify the defects found and specify the measures to be taken if any defects are found during normal production operation.
1.2.2 Inspection method
7.2.2. 7.2.2.2 For the packaging of openable components, the following defects should be inspected: a) Irregularity of sterile barrier materials, cracks, fissures, holes or broken parts; 3) There are foreign substances: ||tt| ... 7.3 Tightness/closure evaluation 7.3.1 According to 7.3.2 to 7, the closure of the sample shall be evaluated. 7.3.2 The sealing performance shall be verified by material testing to confirm the sealing performance and continuity of the sample. The microbial barrier test (5, 1.4) of the material shall be conducted to test the integrity of the aseptic packaging component. 7.3.3 There are some requirements on the elasticity of the seal. 1.3.3.1 The sealing process shall be completed within the specified range. The sealing strength shall be determined at the lower limit of the compensation parameter. 1. The sealing process shall be completed within the specified range. Confirm whether it meets the expected value. Note: The average sealing value is the evaluation method for the tightness.4. Specific process validation requirements apply:
) Process validation should be carried out during processing and assembly: upper! Packaging should be carried out within the upper and lower limits of production, and the final packaging should be prepared appropriately <see Chapter 7) Sustainability: The following characteristics should be considered:
1) For forming and assembly:
-: Packaging reduction/packaging complete;
The product is packed in the packaging is
a size that meets
.
) For livestock:
- Complete description of the sealing width;
Perforation or gradual opening;
- Material separation or separation
- A through-hole or opening case.
3) For other integrated systems:
A continuous gap is closed:
. A perforated or gradually opened:
The material will be divided into islands and islands.
The physical performance test of the packaging produced under the process upper limit or over-setting or under the condition of quantity damage should be carried out on the packaging. 7.5):
E.3 Process performance appraisal
6.3.1 The performance difference should be determined by adjusting the production process under the specified operating conditions. The effectiveness of the process should be verified.
Design, process development and support for accurate performance adjustment 6.3.2 The documented procedures and specifications for the rate control requirements of the packaging operation should be established and integrated into the process performance appraisal. The system should include: 1) machine procedures:
6 effective test methods for the quality of the package such as tightness, pressure, torque and retention time, including design and maintenance:
7 effective test methods for the quality of the package such as tightness, selection and integrity, d) process self-contained procedures.
6.3.3 The appropriate number of test samples specified in the documented product case shall be repeated for each run to achieve the reproducibility of the effective run. The basic process changes should be observed and documented. 6.4 Process Control
6.4, 1 After the process is confirmed, the manufacturer shall establish a procedure to ensure that the packaging process is under normal control. 6.4.2 The manufacturer shall fully verify and establish the control method for the obstruction. E., 3 Packaging and density process documents · The selection of packaging materials should be carried out according to the formation, certification and approval change procedures of the situation documents:
CB/T 19633-2D05/ISO 11607:2DC36.5 Process certification and reconfirmation
65, 1 as the last step of this confirmation procedure, pass! This review and approval does not represent the meaning of the relevant documents. The following key points should be included in the technical summary:
AL The total station for completing the development and/or identification work; h) Find technical data and/or reference materials with design significance: ., Discussion of major problems and corrective measures taken to solve the problems, 6.3, 2 Initial confirmation of the plan and the effectiveness of the safety and uniformity of the equipment and output value, packaging materials or packaging. If there is any change that may affect the safety of the device during the initial confirmation and the effectiveness of the plan, the plan should be reconfirmed: 7 Final (product) packaging
7.1 Test selection and sampling
7.1.1 The manufacturer shall select the sampling plan for the test group based on the manufacturer's requirements such as AQL.P() and document the selection and inspection procedures. 7.1.2 Each test selection for the final package acceptance cannot be considered as a separate procedure. All tests should be considered comprehensively to ensure that the assembly system is confirmed:
Note: Additional tests may be required for special requirements (such as small parts of the machine). 7.13 When the test package is not assembled on a confirmed production line, the assembly system and process used should be as close as possible to the expected production conditions:
7.2 Visual inspection of the integrity of the sterile package
7.7.1 Visual inspection of packaging integrity 7.2.1 The inspection shall be conducted by a visual inspection person or a regular visual inspection person under the specified conditions of use, location, light source, time and (if necessary) conditions.
7.2.1.2 The manufacturer shall classify the defects found and specify the measures to be taken if any defects are found during normal production operation.
1.2.2 Inspection method
7.2.2. 7.2.2.2 For the packaging of openable components, the following defects should be inspected: a) Irregularity of sterile barrier materials, cracks, fissures, holes or broken parts; 3) There are foreign substances: ||tt| ... 7.3 Tightness/closure evaluation 7.3.1 According to 7.3.2 to 7, the closure of the sample shall be evaluated. 7.3.2 The sealing performance shall be verified by material testing to confirm the sealing performance and continuity of the sample. The microbial barrier test (5, 1.4) of the material shall be conducted to test the integrity of the aseptic packaging component. 7.3.3 There are some requirements on the elasticity of the seal. 1.3.3.1 The sealing process shall be completed within the specified range. The sealing strength shall be determined at the lower limit of the compensation parameter. 1. The sealing process shall be completed within the specified range. Confirm whether it meets the expected value. Note: The average sealing value is the evaluation method for the tightness.1! The following defects shall be tested by a visual inspection person or a regular visual inspection person under the specified conditions of use, location, light source, time and (if necessary) conditions.
7.2.1.2 The manufacturer shall classify the defects found in the new product and clarify the measures to be taken if the defects are found in the normal production process.
1.2.2 Test method
7.2.2.7 The external and internal parts of the final packaging shall be tested for the following defects: a) Irregularities of the sterile barrier material, cracks, fissures, holes or broken parts; b) The presence of foreign substances; c) Tightness of the seal (incomplete seal); d) The presence of airtight media or watermarks.
7.2.2.2 For startable components, the following defects should be checked: foreign matter, especially foreign matter in the embedded parts; a)
%! No teeth! There shall be no scratches on the inner surface of the material, and there shall be no cracks, punctures or breaks in the package (not evenly distributed, small-sized, discontinuous seals). d) There shall be no acceptable source of moisture or air.
7.3 Tightness/closure evaluation
7.3.1 According to 7.3.2 to 7, the closure of the packaged sample shall be evaluated. 7.3.2 The sealing performance shall be evaluated by material tests to confirm the tightness and continuity of the package. The microbial barrier test (5,1.4) of the material shall be conducted to test the integrity of the aseptic packaging component. 7.3.3 There are some requirements for the elasticity of the seal. 1.3.3.1 The sealing process shall be completed within the specified range. The sealing strength shall be measured at the lower limit of the maximum compensation parameter change. 1. The sealing strength shall be confirmed whether it meets the expected value. Note: The average value of the sealing seat is the evaluation method for the tightness.1! The following defects shall be tested by a visual inspection person or a regular visual inspection person under the specified conditions of use, location, light source, time and (if necessary) conditions.
7.2.1.2 The manufacturer shall classify the defects found in the new product and clarify the measures to be taken if the defects are found in the normal production process.
1.2.2 Test method
7.2.2.7 The external and internal parts of the final packaging shall be tested for the following defects: a) Irregularities of the sterile barrier material, cracks, fissures, holes or broken parts; b) The presence of foreign substances; c) Tightness of the seal (incomplete seal); d) The presence of airtight media or watermarks.
7.2.2.2 For startable components, the following defects should be checked: foreign matter, especially foreign matter in the embedded parts; a)
%! No teeth! There shall be no scratches on the inner surface of the material, and there shall be no cracks, punctures or breaks in the package (not evenly distributed, small-sized, discontinuous seals). d) There shall be no acceptable source of moisture or air.
7.3 Tightness/closure evaluation
7.3.1 According to 7.3.2 to 7, the closure of the packaged sample shall be evaluated. 7.3.2 The sealing performance shall be evaluated by material tests to confirm the tightness and continuity of the package. The microbial barrier test (5,1.4) of the material shall be conducted to test the integrity of the aseptic packaging component. 7.3.3 There are some requirements for the elasticity of the seal. 1.3.3.1 The sealing process shall be completed within the specified range. The sealing strength shall be measured at the lower limit of the maximum compensation parameter change. 1. The sealing strength shall be confirmed whether it meets the expected value. Note: The average value of the sealing seat is the evaluation method for the tightness.
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