Sterile Medical Dedicated Sealing Machine, Sterile Medical Sealing Machine

Sterile medical special sealing machine, sterile medical sealing machine

Suitable for the sterilization requirements and service environment of clean workshops; it can be used for heat sealing of Class III medical packaging in Class 10,000* clean workshops, such as the fusion between PET, APET, PET, PETG blister boxes and medical composite paper, etc.

Shanghai Zhuanjing Industrial Co., Ltd. (www.zhuanjing.net) specializes in the production of: fully automatic blister forming machines, high-frequency machines, high-frequency heat-sealing machines, high-frequency welding machines, ultrasonic welding machines, ultrasonic welding machines, PET eco-material fusing machines, fully automatic baffle and bar welding machines, automotive leather and sponge heat-sealing machines, medical special sealing machines, cutting machines, blister sealing machines, blister folding machines, heat-shrink packaging machines, skin packaging machines, matching molds, etc.

Sterile medical special sealing machine, sterile medical sealing machine – Equipment features:

1. Body material: the overall frame structure is 304 all-stainless steel, with Japan Kobe 5052, US aluminum 6061 and linear guide rails; the equipment's levelness is very accurate, with an error of ±0.5 mm;
2. Components used in the whole machine: PLC LCD touch-screen automatic control system, PLC programmable controller, Japanese Omron (temperature controller, timer, intermediate relay, temperature control module) to ensure a heat-sealing temperature error of ±1°C; the heating part uses Kobe Steel 5052 aluminum with good thermal conductivity and a low deformation rate;
3. An imported AirTAC aluminum-alloy cylinder provides stable pressure (high output 16000N), and a precision frame structure (drawer-type parallel push-pull linear guide rails, four independent guide-post design) makes the pressure on the mold more even;
4. The mold is custom-made from aviation aluminum, CNC precision-machined with a Teflon coating, with a mold temperature error of ±1°C;
5. In addition, the equipment is also equipped with parameter display and regulation functions, production counting and parameter recording, and a sealing-cycle parameter confirmation alarm system; the control electrical components are all imported;
6. The equipment is simple to operate, the heat-sealing mold is easy to replace, and the process is easy to control.

Sterile medical special sealing machine, sterile medical sealing machine – Widely adopted by the medical packaging industry:

1. The heat-sealed products can be judged by visual inspection from appearance to welding strength, and by sealing-strength tests, peel tests and dye penetration tests; compared with other equipment, the sealing effect can be regarded as superior.
2. Our equipment models are complete (single-station, dual-station, with optional automatic heat sealing), and the appropriate equipment can be selected according to different products and different outputs; our equipment has both a price advantage and a quality* assurance advantage;
3. We can quickly produce welding molds for customers and carry out technical development of new products;
4. We can provide customers with professional manufacturers of Class II and III medical devices and a biopharmaceutical outer-packaging blister shells, as well as suppliers of DuPont Tyvek breathable paper

Chinese and English: PLC LCD touch-screen control system

1. System scalability: production counting and parameter recording, standard USB and network connection ports; and online printing (optional for users);
2. Working-mode memory: parameter display and regulation — pressure, temperature and heat-sealing time can all be stored;
3. Diverse operation modes: three working modes — dual-linkage, automatic and standby;
4. Forward-looking machine design: large stainless steel frame design, which can effectively prevent machine failures caused by overheating of electrical components, and is equipped with an alarm system;
5. Outstanding working performance: it can run at a constant temperature for long periods without interruption; main components have a 2-year warranty.

Model ZJ-3000 ZJ-3600 ZJ-4200

Power 3000W 3600W 4200W

Working air pressure 4～5KG 5～6KG 6～7KG

Voltage 220V Temperature control ±1°

Applicable materials Medical DuPont paper, Tyvek paper, Typar paper, medical coated paper Medical PVC, PET blister

Applicable clean workshop Class 10,000*, Class 100,000*, and above clean workshop

Working size (mm) 300×450 300×550 300×650

Machine size (mm) 900×800×1600 900×800×1600 900×800×1600

Net weight 200KG 250KG 280KG

Introduction to Biocompatibility sealing test items:

Item name Test basis Certification category

Vacuum leak test ISO 11607: 2006 ASTM F1980-02 CMA&CMAS

Seal peel test Peel test can only be carried out 40 hours after heat sealing; tensile speed: 200～300nm/min; ASTM 88-06, ASTM F1980-02 CMA&CMAS

Dye penetration test Standard test method for detecting the seal integrity of porous medical packaging using dye penetrant; ASTM F1929-1988, F1980-02 CMA&CMAS

Test Burst point pressure ≥12.6KPa or 50.81 in;H20 ASTM-1140-00, ASTM F1980-02 CMA&CMAS

Accelerated aging test Standard guide for accelerated aging of sterile medical packaging products ASTM F1980-2002, ISO 11737-2:1988 CMA&CMAS

Medical packaging trends that cannot be ignored → Shanghai Zhuanjing Medical Packaging Machinery

In recent years, four major trends have emerged in the field of medical device packaging. For medical device manufacturers, these trends can be seen both as a challenge and as an opportunity. Clinicians and other surgical staff may prefer rigid lidded trays, such as PETG trays packaged with Tyvek.

In medical packaging, medical device manufacturers have many issues to consider. Device manufacturers must strive to meet the requirements of healthcare institutions, consider how to streamline packaging to reduce costs, cut waste, ensure standardization, and adopt unique technologies to design composite products suited to pharmaceuticals and medical instruments.

Meeting all the above requirements is not simple, but if these challenges can be successfully addressed, it can increase the chances of products gaining market acceptance. In today's fiercely competitive business environment, any advantage is beneficial. The US FDA requires every product to be packaged, so why not make packaging a competitive advantage? This article explores the industry trends that medical device manufacturers face when selecting packaging and discusses how to meet those challenges.

●Responding to the needs of healthcare institutions ()

For medical device manufacturers, success can be defined as developing and selling medical devices that meet unique medical needs or greatly improve existing technologies. These products are developed directly for patients and their specific needs. In addition, device manufacturers must strive to improve the efficiency of the procedure or reduce recovery time. Producers must recognize that patients are the true focus of medical progress, and the purpose of product improvement is to achieve better treatment outcomes. But if the medical-technological differences between products are minimal, the manufacturer's goal is to sell more medical devices than its competitors.

One important determining factor is persuading healthcare institutions to choose and use your device products. Healthcare institutions include doctors and nurses in the operating room, as well as other hospital staff. In many cases, they will choose the more ** medical technology. But what happens when they choose among three similar devices? They must make a choice based on other factors. One of those factors is the packaging that protects those medical devices.

A survey initiated by the Institute of Packaging Professionals (IoPP) and conducted among members of the Association of periOperative Registered Nurses (AORN) in the United States can shed light on the needs and preferences of healthcare institutions. One preference is the type of packaging. Among all respondents, 60.4% preferred formed rigid trays with lids, while 19.3% favored flexible pouches. In addition, 13.9% preferred header bags, and 6.4% chose formed flexible pouches with lids. In addition, 84.4% of nurses wanted medical devices to be packaged using a dual barrier sterilization system.

In this survey, respondents said that being able to quickly read labels and quickly open the packaging during surgery is very important. When evaluating labels, sterility indicators and product shelf life are important considerations when selecting products. Clearly, universal labeling requirements must also be marked, and device manufacturers must focus on label design to strengthen the advantage of this preference.

In addition, the tray wraps the product within the cavity, which can reduce the incidence of common problems. For standard medical packaging, the problems that occur most frequently are wear of the packaging material and tearing of the pouch corners. Furthermore, 98.7% of respondents indicated that they check the packaging before opening it, while 60% check after opening it. Dumping the product directly onto the sterile field is a common practice, considered acceptable by 57.5% of respondents.

The message learned from this survey is: not all packaging is equally recognized. Success depends mainly on user preferences. Packaging designed according to the specific needs of medical users helps increase market share, especially when competitors do not pay attention to packaging.

●Must move toward green development ()

Bioplastics used in medical devices still have sterility issues.

Sustainability. Green. Eco-friendly. These terms can be heard every day. There is increasing pressure to re-examine existing practices from the perspective of efficacy. More and more companies care about whether they can be good citizens of the natural environment and are paying increasing attention to their carbon emissions.

As medical and pharmaceutical companies begin to evaluate their own green environmental plans, one of the metrics that receives close attention is packaging. These discussions involve many aspects, including specific packaging materials and the processes by which suppliers produce the packaging. At present, numerous R&D projects are under way in the packaging field to develop more eco-friendly products and bring them to market.

In the packaging field, green materials have broad market space. For example, the food packaging industry began using polylactic acid (PLA) produced by NatureWorks many years ago. This is a material derived from corn and is extremely popular. The material's advantages lie in its rapid biodegradability and compostability.

Many such materials have begun to be applied in the cold-food packaging market. However, compared with traditional petroleum-based plastics, today's bioplastics still have many limitations in impact strength and heat-deformation characteristics. Today, many bioplastics are still far from meeting the evaluation standards for sterile barrier systems. Nevertheless, device OEMs should recognize that this technology is advancing rapidly and may soon be able to meet the needs of ordinary packaging.

As technology continues to improve, some of these green materials will become available for use in medical packaging. At the same time, several large medical device manufacturers have begun to evaluate other streamlining mechanisms. For example, some companies are trying an extremely simple method that can save raw materials. Companies must also evaluate the current packaging structure and determine whether, by streamlining the specifications or the packaging of some components slightly, it can achieve the same product protection effect. These small changes can save large amounts of raw materials.

Many packaging systems are over-designed. Streamlining packaging also helps control costs. For example, the commonly used dual sterilization packaging system. Usually, if designed properly, it can be streamlined into a single sterilization system.

●PETG pellets are usually regenerated and processed into sheets, which can be used for the packaging of Class I non-sterile or over-the-counter devices. ()

Another way to achieve sustainability is to use recycled plastic, in most cases post-industrial recycled plastic. This process has been successfully applied in food and consumer goods packaging for many years. The ideal use of recycled plastic is in the field of ordinary medical packaging, such as (heavy-duty) blister trays used repeatedly during production, medical consumer product packaging and non-sterile medical product packaging. This is common especially in rigid packaging using materials such as HIPS and PET.

There are basically two ways to obtain recycled or reprocessed materials. One is post-consumer recycled material (for example, PET soda bottles). Because of the higher requirements, this material is difficult to obtain. The other source is post-industrial recycled material (scrap from the packaging line or waste generated after processing, recycled back into the material source). By comparison, this material is easier to obtain and provides an interesting source for packaging.

The Sustainable Packaging Coalition (SPC) is one of the organizations actively promoting the use of recycled materials and streamlined packaging. The SPC is an industry working group that champions the "cradle-to-cradle" environmental concept. It is committed to transforming packaging into a system that both encourages economic prosperity and enables sustainable sources of materials. Some medical companies, including Abbott and Johnson & Johnson, have become members of the SPC.

One of the main challenges facing medical device packaging engineers is bringing the packaging system to market quickly. In many cases, there is only a very short time to adjust the packaging system before applying to the US FDA. Therefore, it is crucial for engineers to have a clear and reliable procedure for validating packaging. Part of the 510(k) or premarket approval process involves validating medical device packaging systems to ensure that the safety and efficacy of the device are not affected. For the US FDA, reviewing packaging validation is a documentary process, i.e., providing evidence of long-term compliance with predetermined requirements.

Over the past 20-plus years, medical device packaging professionals have been refining the ISO 11607 standard, which was created in 1997 and revised in 2006, aiming to establish a globally unified standard linking ISO 11607 with EN 868-1 and creating a common platform and language. Ultimately it became a standard applicable to the medical device industry.

Before ISO 11607:2006 certification, every manufacturer wanting to enter the US market had to submit a 510(k) to the US FDA; however, the submission methods of different manufacturers varied. ISO 11607:2006 fills this gap. Therefore, it provides a roadmap for device manufacturers to meet the standard.

The American Association for the Advancement of Medical Instrumentation (AAMI) updated and published a guidance document, Technical Information Report (TIR) 22:2007, as a supplement to the standard. TIR 22:2007 is a practical commentary edition of ISO 11607:2006, providing packaging engineers with practical operational guidance. TIR 22:2007 focuses on describing the specific application details encountered by packaging engineers. It can provide in-depth detail to help engineers responsible for the design and development of packaging systems but who have not been trained in packaging engineering design. In many small and medium-sized device manufacturing companies, product development engineers also need to be responsible for packaging work.

This committee dedicated to the integration of ISO 11607:2006 faced many obstacles, one of which was the clear description of terminology related to medical packaging. To establish a globally widely recognized platform, this work is extremely critical. Thus the following four main term definitions emerged. These definitions can effectively promote the correct use of ISO 11607:2006 and TIR 22:2007, as follows:

1. Packaging system. The combination of the sterile barrier system and protective packaging.
2. Protective packaging. The material structure used to protect the sterile barrier system and its contents from damage from assembly through use.
3. Sterile barrier system. The small packaging structure that prevents the entry of microorganisms and allows the product to remain sterile at the time of use.
4. Preformed sterile barrier system. A partially assembled sterile barrier system used before bagging and final sealing.
5. For specific surgical instruments, a tray placed in a Tyvek pouch may be the packaging method preferred by users.

Most medical device packaging engineers regard ISO 11607:2006 and TIR 22:2007 as the bible of packaging development. Every decision that medical device packaging engineers make regarding design, material selection, sterilization, production, packaging testing, documentation, auditing and supplier certification is benchmarked against ISO 11607.

●Composite products — a new challenge ()

As medical technology continues to advance, packaging technology must also develop accordingly, to protect medical innovations and to meet the new challenges brought by technological progress. Advances in biotechnology, pharmaceuticals, biologics and nanotechnology are causing these fields to continually converge. One of the fastest-growing areas is composite products combining drugs and medical instruments. According to BCC's research, the global market value of drug-and-medical-instrument composite products in 2004 was about US$5.4 billion, and it is expected to keep rising at an average annual growth rate of 13.3%, and is expected to reach US$11.5 billion by 2010. One of the main composite products is the drug-eluting stent, which is expected to grow at 11.5% per year before 2010.

These increases place new requirements on packaging system technology and regulation. To address the regulatory issues of composite products, the US FDA established the Office of Combination Products (OCP) in December 2002. The OCP is responsible for regulating many aspects of the composite product lifecycle, but it will, based on the nature of the individual composite product, assign it to one of the FDA's three product centers to be responsible for the specific primary regulation and oversight work. These three product centers are the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.

●Composite products as defined in 21 CFR 3.2(e) mainly include drug-device, biologic-device or biologic-drug. Generally, they can be divided into the following categories:

1. Physically or chemically combined into a single entity.
2. Co-packaged.
3. Cross-labeled products packaged separately.
4. Investigational drugs packaged separately and recommended for cross-labeling.
5. The packaging of drug-delivery devices such as syringes may require attention to temperature and sterilization issues.

Traditionally, medical devices can be clearly classified according to packaging and sterilization requirements. The main role of medical device packaging is to provide protection during supply and sterilization and ultimately ensure that the device is sterile before use. Composite products increase the complexity of the packaging system and pose new challenges in many respects, such as stability during shelf life, solvent loss, packaging testing, and protection against moisture and oxygen ingress. Pharmaceutical products may also require additional packaging qualification.

For composite products, the barrier protection function is a key factor determining packaging success. When evaluating packaging options for rigid plastic trays, many technologies for moisture protection can be found. A well-known technology is covering PVC or PETG with Aclar film. Generally, the Aclar structure ranges from 0.0006 to 0.003 inches, depending on the moisture vapor transmission rate (MVTR). PVC/Aclar structures are widely used in the pharmaceutical industry. PETG/Aclar is increasingly used in the fields of composite products and biologics. But it also faces many challenges, one of which is the limited draw depth of Aclar film. Thermoformed trays covered with Aclar film are usually no more than one inch deep.

●Technicians evaluate the packaging of specific items through quality inspection.

Another moisture-protection option on the market is co-extruded material of cyclic olefin copolymer (COC). This technology was developed for the composite product market. The co-extruded material is the core of COC, with the surface covered by PETG or polypropylene. Because COC is a co-extruded material with no film covering, one of its advantages is that its draw depth can reach 5 inches. For many rigid trays of a certain depth, elasticity is very important. Depending on the target MVTR, the size of the COC core ranges from 0.005 to 0.040 inches. COC is a non-crystalline material with good transparency, and can be sterilized using ethylene oxide and radiation sterilization.

As competition intensifies, medical device manufacturers need to seize every opportunity to enhance their competitive advantage. Packaging is one of the frequently overlooked areas. Understanding and finding ways to meet customers' needs is crucial. Mastering packaging technology, international packaging standards, green initiatives and designing for user needs can all help device manufacturers expand market share.

As a provider of overall medical packaging services, Shanghai Zhuanjing Company — the ZJ-4200 medical heat-sealing machine — can accompany its partners through the entire product packaging process, from packaging design to confirmation, joining hands to create a common end product and serve common end customers.

——This article is reproduced from China Packaging Network (pack.cn), original link: http://news.pack.cn/show-377861.html