The development of the hottest medical packaging i

The development of medical packaging is in line with the world (Part 2)

to sum up, this definition will include trays with covers and sealed pockets. If the sealing bag is planned to be a dust cover rather than a sterile barrier, it can also be just a tray with a cover. The preset barrier system is a "device to prevent damage to the sterile barrier system after packing and before the final unpacking", and includes small bags, sealed bags, and opening reusable sterilization containers. Protective packaging is "a packaging structure designed to protect sterile barrier systems and contents from damage from assembly to use". This definition includes shelf boxes, shipping cartons, and any other packaging used to protect sterile barrier systems. The packaging system is "the combination of sterile barrier system and protective packaging", and includes all packaging through the cargo container. Sterile liquid channel products, such as tubes that control fluids for infusion, are designed as closed-circuit systems to form a sterile barrier system to keep the interior of the catheter sterile and allow sterile exposure. A small bag wrapped with an infusion tube is marked with a sterile liquid path, which cannot be regarded as a sterile barrier system, but a dust cover

the expansion of Part 1 is mainly reusable container system and reusable textiles mainly used in hospitals. The focus of these contents is to ensure that the performance is guaranteed during the use of the entire sterile barrier system

validation process of preset sterile barrier system. Another potential impact of the ISO draft manual graded dispensing experimental space is that the preset sterile barrier system requires the use of confirmed process production. For many aseptic packaging manufacturers in the United States and the European Union, many of their customers require process validation, but this requirement has a significant impact on underdeveloped countries

test method. Now, the solution provided in part 1, draft 8, includes two new attachments. One is an extensive catalogue of test methods that meet the requirements of the standard. The catalogue information is rich but not standard, which indicates that if they are properly verified, other test methods can also be used. Another attachment is an introduction to medical packaging, which is useful for non packaging professionals to have a little understanding of medical packaging

en 868 part. The ISO Committee has determined that these drafts meet the needs of Cen. It is expected that when these drafts are put on trial for five years, cen will retain them and begin to revise them. ISO has adopted these drafts as information references in the draft. These drafts can be used to prove compliance with the applicable part of the ISO draft, which is currently the applicable part they use to show how to comply with en, and there is no plan to transfer the authority of these drafts from Cen to ISO

industry impact

if these draft standards are adopted, they will inevitably affect medical device manufacturers, sterile packaging manufacturers and hospitals worldwide. If a device manufacturer wants to sell a set of sterile medical devices in Europe, it must show compliance with the medical device directive, that is, to prove compliance with the sterile packaging provisions of the directive by following en. If the packaging used includes one or more parts of en 868, compliance with en requirements can be shown by consistency with these parts. If any draft standard is approved as a draft of en, compliance with the Equipment Directive is displayed by following this new ISO/en standard

if the draft is adopted as an en standard, manufacturers selling preset sterile barrier systems in Europe will be required to confirm the process of sealing and closing systems for goods in their small bags, sealing pockets and drums. If Europe chooses not to adopt Part 2 (and only part 1), this requirement does not need to be followed in Europe. The main reason for adopting the two parts of the standard in Europe is the validation of all processes. Why does the final seal on the small packaging bag need to use the product produced by the approved process, while all other seals do not need this process? In the United States, the pre-set sterile barrier system sold to hospitals is considered by FDA to be a medical device, so the quality system regulation (QSR) requires verification of the packaging process. European hospitals are not required to follow the Medical Equipment Directive unless they sell sterile products to the market. However, they can voluntarily choose to follow en. If 11607 draft is adopted, they will be able to follow automatically or both. If the hospital sells sterile products to the market, it will be regarded as the behavior of the equipment manufacturer, and must show compliance with the instructions and standards as described above

follow ISO 11607 packaging for terminally sterilized medical devices in the United States, medical device manufacturers do not have to follow ISO 11607. However, because FDA has approved the first edition, manufacturers can choose to declare compliance in 510 (k) submitted to them. The reprint has been nominated for FDA approval and will soon be published as a recognized standard in the Federal Register. If the new drafts are recognized as ISO standards, they will be nominated for FDA approval and registered for publication once approved

if the new drafts are approved, they may also be voted as ansi/aami standards with a view to being approved as American national standards. The new draft of 11607 does not contain requirements that are not addressed in the current version of 11607. American equipment manufacturers have mainly used 11607 as a guide, with little follow-up to prove that their compliance is corresponding. However, several manufacturers have used consistent instructions after the submission of new equipment, and this trend should continue

aseptic packaging manufacturers that produce and sell preset aseptic barrier systems have achieved process validation to varying degrees in the United States. Some processors will introduce to you the selection and measurement of pressure testing machines. Precautions to confirm everything. Some will only confirm their processes according to the needs of customers. If they also manufacture goods in small bags and drums for sale to hospitals, the process must be confirmed to comply with QSR. If both ISO and the draft are adopted, it will further promote the verification of the whole process

11607 the applicability of the proposed draft in American hospitals is basically the same as that in Europe; If you can choose, Europe will voluntarily adopt 11607 as the standard. The problems in the hospital seem to be related to the second part of the proposed validation packaging process. For example, consider medical equipment wrapped in a central supply space (CSR) before sterilization. Some hospital representatives believe that this kind of packaging process in the hospital can never be approved, while others insist that it can be approved. The argument lies in the ability to prove that closing the box with folded form can maintain the sterility of products, and the procedure to prove that the folded form is actually implemented in the CSR area according to the instructions. It may not be easy, but it can also be done. More importantly, because the process of producing the preset sterile barrier system must be confirmed, it is meaningful that the final sealing and closing system should also be confirmed. Unless the closing process is confirmed, it is difficult to prove that the product can remain sterile before use

each country handles regulations differently. Countries outside North America and Europe use the current en 868 and ISO 11607, which are consistent with similar standards used in Europe or the United States. Several Asian countries are considering adopting en 868 or ISO 11607 as regulatory requirements. The integration of these drafts allows these countries not to choose which standard to use

summary

the packaging system of sterile medical equipment is an important component of putting safe and effective products into the global health care market. A long standard catalogue indicates all sterilization types in sterilization and validation sterilization in industry and hospitals

if the packaging system does not implement the standard, the sterilization process, no matter how good, will be meaningless. If the packaging of sterilized products is improperly designed or selected, or if there is an error in the production process, it will lead to further problems, making the products contaminated and unusable. Today, we already have two specifications and standards for medical packaging, and the relevant ISO and Cen committees are working diligently to obtain globally consistent and unified specifications and standards

this article was written by Dr. Michael H. scholla, senior consultant of DuPont medical fabrics and packaging (Wilmington, Delaware)

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