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China's medical equipment sterilization packaging status and related considerations (five)

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I believe that for most people involved in packaging related work, "packaging process verification" should be a very strange term, because it is not a theoretical type of vocabulary, so the general university or vocational school textbooks There is no such term.
Packaging Process Validation
I believe that for most people engaged in packaging related work for e-commerce, "packaging process validation" should be a very strange term, because it is not a theoretical type of vocabulary, so the general university or vocational school textbooks there is no The term. To be precise, apart from the phrase "packaging process", the word "verification" itself should be a typical vocabulary of the industrial sector. The common industrial fields are the IT semiconductor industry, the pharmaceutical industry and the medical device industry. It can be seen, "verification" is a rigorous vocabulary, which is applied to some of the process safety and stability requirements of the industry is very high, the packaging industry has not been a security or stability is very sensitive to the industry, therefore The industry to understand the "verification" and fewer people. However, when the packaging and packaging to be built into consideration when the Chinese printing companies strong, the packaging of packaging requirements played a decisive role, this paper is one of the typical MDSP.
Or take a look at the relevant standards and regulations on MDSP process validation requirements. The first is ISO13485-2003, which is a modified inherited the ISO9001 quality management system, such as general-purpose and specifically applicable to the medical device manufacturing industry integrated quality management system, which clearly provides for those in the production or service process can not be followed by the sequence It is necessary to verify the operation and management, but only after the delivery of products or services in the process of appearing in the process, it is clear that the packaging heat sealing process and sterilization process is the most two of the most Typically require verification because they can not be monitored by subsequent monitoring or measurement means to confirm that they meet the expected design requirements, and only when the product or service is being used can the final confirmation of its existence problems. Konica Minolta
Then look at the EU Medical Device Directive on CE certification part of the offset, which clearly stipulates the packaging and sterilization process verification report and product technical drawings and specifications and other documents together, is essential to form the CE technical documents section. In other words, in order to obtain CE certification, packaging process validation is essential. Of course, the actual situation may not be so EFI, for example, you have a range of products, in accordance with the requirements of ISO11607-2006, you can choose one of the most challenging products, such as the most weight, the largest size, sharp protrusions, and its Packaging process validation policies and regulations, and then use a written document describing your choice of this most challenging products rationalization reasons, and archived as part of the verification report, you can prove that this series of products are certified by the packaging .
The above mentioned ISO 11607-2006 is also related to the MDSP process validation standards, and it is also one of the most direct and detailed on the MDSP process validation standards, the second part of the clear provisions of the preformed sterile barrier system (PSBS) And sterile barrier systems (SBS) are required to verify the necessary heat-sealing processes in their manufacturing processes. Unfortunately, offset printing, the current domestic medical device packaging suppliers have not been in the production process must be heat sealing process of systematic validation, and related knowledge and training is also very lacking.
While all three of these regulations specify the need for MDSP process validation, the concepts presented in these standards for MDSP process verification are generally difficult to understand for the average person. Broadly speaking, process validation is interpreted as a documented process, that is, those with the product packaging quality and stability of the factors related to information and packaging of the general principles of documents, and the formation of the verification report process. In accordance with the GHTF (Global Harmonization Task Force, the global medical device standards and regulatory coordination organizations, mainly responsible for Europe, the United States, Japan, Australia and other developed countries and regions related to medical device standards and regulations of the harmonization and coordination) in 2004 released a In the process known as "Process Validation Guidance," the validation process is a process to ensure continuous process stability, but in the end it is necessary to file a very systematic form to submit a verification report vendor information, and There are relevant experimental data to support this report. Of course, GHTF's documentation is suitable for many processes used in the manufacture of medical devices, such as sterilization and injection molding, not just for the packaging process, but the FDA also recommends this guidance as a reference for medical device manufacturers for process validation . Screening
Written here, I need to clarify the domestic industry is very easy to confuse the two concepts of delivery, because it involves the Chinese and English equivalence of translation issues. The first is Verification, literal translation is "confirmation, verification," the meaning of such a range is relatively small, the concept of relatively weak, can be a simple data, experiments or drawings to prove that a design meets the expected requirements, such as The actual heat seal strength of the sample data to prove that it meets the expected range of settings; the second is Validation Network Publishing, is the "verification", it is a very large concept, including the collection of various programs, evidence And data to demonstrate the continuous stability of the packaging process. The difference between these two concepts is a headache, I have this experience, the original is "Verification" translated as "confirmation" activities, the "Validation" translated as "verification", but later learned that industry authority The company's translation results just the opposite, the author can only follow their name. However, this article referred to the "verification" or the concept of Validation, I believe that this is the other popular domestic packaging, but it is relatively easy to accept the name.
After the introduction of the MDSP process validation standard regulatory requirements and basic concepts and other related information activities, we will talk about how to carry out specific MDSP process validation work. Obviously, a necessary verification scheme is essential for a complex, systematic effort to successfully complete MDSP process validation, which is provided by an experienced validation team. A qualified packaging process validation program should include at least the following points.
(1) the scope of validation: such as packaging, packaging materials and related equipment to determine the heat sealing, and re-verify the conditions.
(2) The three essential components of process validation: Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ), it is clear that here the Qualification has also been translated into "confirm" printability, but not the concept of Verification.
(3) Checklist items in IQ, training records of equipment operation and calibration records of equipment parameters; the definition of the key process parameters and key acceptance criteria in OQ, find the description of the optimum process parameter interval method; Sample experimental program and experimental data; PQ in the batch definition and related samples of the experimental program, experimental data, verification conclusions.
As can be seen from the above, in addition to the scope of validation and other necessary information outside the layout design, the rest of the content and MDSP process validation are the three necessary components IQ, OQ and PQ related to the following are focused on the three concepts . label
The first is IQ, which requires that the equipment be properly installed at the right location, including adequate operational space, adequate ancillary facilities such as water and electricity, whether the equipment parameters are calibrated, and whether the equipment is capable of responding to production environmental parameters The ability of the fluctuation and the performance of this ability, whether the relevant software of the equipment has been verified and updated, whether the equipment operator has been trained, the drawings and instructions of the equipment are complete, etc., and can list the above information. Into the digital printing post-press processing, and check one by one whether has been completed, if all completed, then the IQ is completed. The device parameter check information table and the operator training table need to be given in the form of an appendix after the IQ section.
Followed by the OQ, it requires to find a consistent and stable production of products in line with the target range parameters (Note that emphasis here is the parameter range, not just a parameter point) packaging logistics, is the core of the verification, Or process equipment and content changes in a more project. You can initially determine the approximate parameters of the OQ range, which can be determined based on the basic characteristics of the material, past experience and historical experience of effective data. Next, we need to design an experimental scheme to confirm the validity of this initially determined parameter range. The design process is usually called the DOE (Design of Experiment) process flow. There are many experimental schemes, depending on the packaging Design and heat sealing equipment to determine, of course, MDSP packaging quality acceptance criteria and project detection methods are also defined in this OQ. It is worth noting that, MDSP packaging quality acceptance criteria are generally self-defined, because the existing packaging details of the standard or lack of universal applicability of the North shares, so the general acceptance of packaging standards to corporate self-standards, open standards For reference only. Finally, according to the DOE to make samples and according to the provisions of the detection method to detect the relevant packaging items, conventional items for the packaging integrity, packaging, protection, clean open and packaging appearance, may be clean open the test index is not in the country There are a number of factors that are important to people and subjective judgments, but this is a critical test for instruments used in the operating room, which is particularly stringent in the US market. If the results of all test items reach a predetermined target value, the parameter interval is regarded as the validated parameter interval; if the film can not be fully reached, the parameters may be fine-tuned. Of course, the actual implementation may be some more skills, where the inconvenience to describe too much, in short, a wealth of experience and knowledge of the material are very helpful in the OQ quickly find the best process parameter range, which is the process development experience and Knowledge of cost savings is a reflection of color management, because according to statistics, a complete process validation is very expensive. ink jet
OQ, it is necessary to determine the parameter range rather than just a parameter point, because for general packaging equipment, such as automatic forming - filling - heat sealing machine and ordinary heat sealing machine, heat sealing mold temperature and air compressor supply If the pressure fluctuation in the normal production process is extremely easy to be cut, if only a parameter point is given instead of an interval, once the normal production must produce the parameter fluctuation beyond the practically acceptable range, There will be unqualified products. In theory, the parameters should be considered an interval rather than a point, but the size of this interval is different manufacturers information, when the range is very small when close to a point. Production parameters should be set in the mid-range parameter range, so when there are fluctuations in the parameters can also have a certain tolerance to space; if the click in the parameter range of the upper or lower limit, even if there are small fluctuations in the parameters, will cause quality Stability of the problem.
Finally, the PQ layout design, which requires that the parameters of the selected space is in large-scale production scale continuous and stable production of qualified products. Of course, PQ is more like a product quality and stability control related projects, with the relevance of engineering and technical departments is not, and its itself is relatively easy to understand and implementation. It is common practice to sample samples in the first three batches of products at the beginning of continuous production at a predetermined sample size and acceptance level (AQL), ​​to carry out the relevant sample testing according to the test items and test methods in OQ, The data comes to the PQ report as a basis for judging whether the entire packaging validation process is finalized.
After a thorough understanding of the core IQ, OQ and PQ of the MDSP process validation and design of a validated verification scheme, the personnel in the production and technical departments can complete the inspection and validation of the equipment according to the requirements of the verification scheme, The establishment of the initial three batches of production quality and stability of the confirmation of the work by the quality department staff responsible for the detection of the relevant data and feedback to the front of color management, if all meet the expected requirements, then these get Parameter information and experimental data into the verification program, you can constitute a final MDSP process validation report.
The MDSP Process Validation Report thus obtained is a complete written record of the results obtained through a series of rigorous testing processes and a strong reason for confidence in the continuous quality of the product packaging. The report contains more general content, such as full program details, experimental project design and the final experimental data commercial rotation in China, and therefore the length is generally very long, 10 pages or more is normal. I confirm the report to customers in general more than 20 pages, of course, our partners in the medical device industry's highest packaging requirements of the enterprise, and the report is bilingual. Inkjet printing
It is noteworthy that, because the packaging certification does not have a fixed pattern of authentication, nor very credible company or organization to give a detailed program template (I have read many large companies in Europe and the United States packaging verification program, each company or each person , And for standardization of packaging validation, each manufacturer of medical device or its packaging supplier should have a template for their own packaging validation program, Manroland, to standardize The company's work in packaging validation, and a unified reporting model. Of course, different products in the test items may not be the same point of consideration, but in the IQ and PQ areas and OQ part of the DOE is very close, so the template is still a certain degree of versatility.
At present the packaging process verification is only used in the field of MDSP digital presses, but based on the depth of understanding of the packaging industry, I believe that as food and pharmaceutical packaging as closely related to the health of consumers, and therefore its packaging design is also very necessary Packaging process validation to confirm the continuous stability of the product packaging; cosmetic and personal hygiene care products packaging protection and security requirements are slightly lower than the above products, but if necessary, also need to verify the packaging; general industrial products and Consumer electronics packaging process is too simple high-fidelity printing, or a low degree of automation (of course, some foreign automated packing equipment is also very advanced), the package integrity or sealing requirements are not very strict, and Emphasis is placed on the transport of the buffer process in the protective packaging, which basically does not require very strict and complex packaging test
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