Medical mold manufacturing capabilities

FEATURES

• MOULD DESIGN AND SIMULATION
  
  
  

  Ansix Medical has decades of experience in precision medical and life science tooling. Our in-house design team uses Siemens NX 3D CAD to deliver efficient, DFM-led designs, from single-cavity prototypes to 128-cavity moulds for high-volume production. Advanced 3D Moldflow analysis predicts cooling times, shrinkage, and warpage to optimise cycle times and ensure consistent part quality.

• Mold Description
  Product Materials:	PP
  Mold Material:	S136ESR
  Number of Cavities:	128
  Glue Feeding Method:	Hot runner
  Cooling Method:	Water cooling
  Molding Cycle	15s

  
  

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  Designed specifically to extend mold life
  
  

  Ansix Medical has successfully designed and manufactured a range of 16-cavity, 32-cavity, and 128-cavity injection molds for the medical device industry. With a focus on detail during the design phase for ease of maintenance, and utilizing steel and special coatings, these molds achieve a cycle life of 40 million cycles, with each run lasting 3.5 to 5 seconds, and a major refurbishment cycle of 40 million cycles.
  
  
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• UNMATCHED ULTRA-PRECISION MOULD MANUFACTURER
  
  
  

  Ansix Medical’ in-house toolmakers in the UK and Singapore ensure precision mould manufacturing with top-quality processes for unmatched accuracy. Our machining capabilities include:

  
  

  Micro Machining

  Optical Inserts

  Conformal Cooling

  Micro Optics 

  Microfluidics
  
  

  We provide custom complex, precision, multi-cavity mould tooling that meet all of your requirements:

  Single tip to multi-cavity hot runner moulds

  Fast cycling tools

  Complex toolings

  Prototype and Proof of concept toolings

  Extreme level in surface finishes, precision and tolerance levels

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• ULTRA PRECISION MACHINING
  
  

  Ansix Medical produces optical inserts for both conventional and micro moulds, machining mirror finishes directly into hardened steel inserts – no additional operations required.

  MICRO MILLING

  Our KERN Pyramid Nano can machine fully hardened steel using cutters as small as 50 microns in diameter (0.002″), with is advanced 5-axis, and a spindle speed of 55,000 RPM.

  GRINDING

  We can work from small to large workpieces in single, small and large series production, for mould inserts manufactures for 16 and 32-cavity fast cycling ophthalmic and IOL moulds.

  MICRO EDM & WIRE EDM

  We can cut through hardened steel with a wire diameter of 30 microns (0.0013″) and a positional accuracy of 0.001mm (0.00004″).

  
  

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• Medical ultrasound scalpel handle mold

  
  

  Ansix Tech Redefines Medical Molding Precision with Ultrasound Scalpel Handle Project

  Revolutionizing Medical Device Manufacturing Through Integrated Design and Cost-Effective Production

  
  

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• Medical Drainage Bottle Mold

  
  

  Engineering the Pulse of Precision: How Ansix Tech Redefines Value in Medical Drainage Bottle Mold Manufacturing

  In the highly specialized and demanding world of medical device manufacturing, the drainage bottle occupies a unique and critical position. Far from being a simple container, it is a life-critical component used in post-surgical wound care, thoracic drainage, and various fluid management applications. It must maintain absolute structural integrity under constant vacuum pressure, offer flawless clarity for fluid monitoring, and be manufactured from materials that are strictly biocompatible. For medical device OEMs, the margin for error is zero, yet the market pressure to reduce costs is relentless.

  
  

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• Medical measuring cup mold for administering medication to infants

  
  

  Engineering Care: Inside Ansix Tech's Precision Revolution for Medical Measuring Cups

  A Commitment to Infant Healthcare and Manufacturing Excellence

  In a state-of-the-art facility in Jiangsu, engineers at Ansix Tech are engaged in a project that blends high-precision manufacturing with profound social impact: the production of injection molds for medical measuring cups designed to administer medication to infants. In the high-stakes world of medical device manufacturing, where margins of error are microscopic and regulatory bars are exceptionally high, this project exemplifies how advanced engineering and strategic process optimization converge to create reliable, affordable healthcare tools.

  
  

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• 96-well deep-well plate silicone cover mold

  
  

  Ansix Tech Pioneers Cost-Effective Precision: Mastering the 96-Well Deep-Well Plate Silicone Cover Mold

  In the high-stakes world of life sciences manufacturing, where reliability is non-negotiable and cost pressures are immense, a single component's failure can derail millions in research. Ansix Tech’s innovative approach to the silicone cover mold project proves that precision and affordability are not mutually exclusive goals.

  
  

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  TOP-QUALITY IN-HOUSE TOOL-MAKING FACILITIES
  

  
  

  In the UK and Singapore, we invest in cutting-edge technology to deliver top-quality mould tooling efficiently for our customers. Our machines include:

  
  

  Kern Pyramid Nano Micro Milling machines: less than 0.5 micron repeatability, less than 10 nm Ra surface finish

  
  

  EDM machines: 1 micron repeatability, 30 micron diameter wire for hardened steel cutting

  
  

  Cylindrical Grinding machines: for mould inserts manufacture for 16 and 32 cavity fast cycling ophthalmic and IOL moulds 

  
  

  We offer mould maintenance services to maximise the lifespan of our moulds throughout their lifetime.

  
  

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• UNLIMITED INNOVATION
  
  

  Ansix Medical drives innovation with cost-effective tooling solutions to maximise both financial and technical benefits for our customers. For example, our Conformal Cooling channels for medical injection moulds reduce the cycle time of a medical packaging part from 6.5 seconds to 3.5 seconds.
  
  
  

  
  
  
  
  

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  FROM RAPID PROTOTYPING TO MASS MANUFACTURING 
  
  

  Ansix Medical delivers fast, efficient prototypes to help verify your project’s future. Our experienced team supports you through every step of on-demand mould projects to ensure the highest quality standards.

  
  

  
  
  
  
  

• Ansix Medical mold manufacturing capabilities

  
  

  Mastering Medical Injection Molding: How Ansix Tech’s Integrated Manufacturing Ecosystem Redefines Value, Quality, and Cost Efficiency

  In the high-stakes arena of medical device manufacturing, precision is not negotiable—it is a prerequisite for patient safety and regulatory approval. From endoscopic surgical instruments and disposable laryngoscope blades to complex diagnostic instrument housings, every molded component must meet exacting standards of dimensional stability, biocompatibility, and long-term reliability. Amidst this demanding landscape, medical device OEMs increasingly seek manufacturing partners who do more than simply produce parts—they require strategic collaborators capable of delivering end-to-end solutions that reduce costs, accelerate time-to-market, and ensure uncompromising quality.

   

  Standing at the forefront of this specialized field is Ansix Tech Limited, a professional manufacturer with over 28 years of injection molding experience, more than 30,000 completed mold sets delivered globally, 260 injection molding machines ranging from 30 to 2,800 tons, and over 1,200 employees including more than 200 designers. With four production bases strategically located across China and Vietnam, a total building area of approximately 200,000 square meters, and certifications including ISO 13485:2016 for medical devices, ISO 9001, IATF 16949, and ISO 14001, Ansix Tech operates as a strategic co-engineering partner rather than a conventional supplier. This exclusive industry analysis explores how Ansix Tech’s holistic, data-driven approach—from project initiation and design for manufacturability (DFM) to precision tooling, high-volume production, and rapid delivery—delivers unparalleled value by systematically reducing product costs, increasing production capacity, and ensuring rigorous quality assurance for medical OEMs worldwide.

   

  Part I: Strategic Project Initiation – Building Value from the First Engagement

  For Ansix Tech, a medical injection molding project does not begin with a purchase order for steel—it begins with a collaborative partnership. The company’s “co-engineering” philosophy invites clients to engage from the earliest concept stage, ensuring that the final product is both technically robust and economically optimized from the outset. Approximately 70% of a product’s manufacturing cost is locked in during the initial design phase, and Ansix Tech’s front-loaded engineering approach systematically captures cost-saving opportunities before a single line of mold design is drawn.

   

  At project initiation, Ansix Tech engineers conduct a comprehensive analysis of client requirements, market demands, and regulatory standards. For medical applications, this includes detailed analysis of intended use environments, sterilization methods (autoclave, gamma radiation, ethylene oxide, or chemical agents), and the specific regulatory pathway the final product must follow—whether FDA 510(k), CE MDR under the European Medical Device Regulation, or NMPA approval in China. This upfront collaboration is the cornerstone of Ansix Tech’s cost-saving strategy, preventing costly redesigns and delays later in the project lifecycle.

   

  Part II: Design for Manufacturability (DFM) – The Digital Foundation

  The cornerstone of Ansix Tech’s engineering workflow is the Design for Manufacturability (DFM) analysis. For medical components that may feature living hinges, ultra-thin walls, and complex internal channels for steering wires and optical fibers, manufacturability is paramount. Ansix Tech engineers scrutinize part designs for potential production pitfalls, examining wall thickness uniformity to prevent sink marks and differential shrinkage, verifying adequate draft angles to enable clean ejection without damaging delicate features, and identifying opportunities to simplify geometry—consolidating what might be multi-part metal assemblies into single injection-molded components.

   

  Key DFM principles applied by Ansix Tech include:

   

  Uniform Wall Thickness: Ensuring consistent wall thickness (typically ranging from 1mm to 3mm for common medical plastics such as PC or ABS) prevents sink marks and warpage, directly improving yield and reducing scrap.

   

  Proper Draft Angles: Precise draft angles (typically 1-3° or more for textured surfaces) ensure clean part ejection, protecting the mold and preventing damage to precision components.

   

  Strategic Ribs and Gussets: Using reinforcing ribs rather than thicker walls to increase strength saves material weight per part—a cost-saving measure that accumulates over millions of cycles without compromising structural integrity.

   

  Part III: Advanced Mold Flow Analysis – Predicting Perfection Before Steel Is Cut

  Beyond fundamental DFM principles, Ansix Tech employs advanced mold flow simulation software, such as Moldex3D, to digitally simulate the dynamic injection molding process before any physical tooling begins. This virtual prototyping predicts how molten plastic will fill the mold cavity, identifying potential issues including:

   

  Air Traps: Pockets of air that can cause incomplete filling or surface burns

   

  Weld Lines: Where molten plastic fronts meet, potentially creating weak points

   

  Sink Marks: Surface depressions caused by uneven cooling in thick sections

   

  Warpage: Distortion of the final part due to uneven shrinkage

   

  Flow Marks and Internal Stresses: Defects that can scrap entire batches

   

  By optimizing gate locations, wall thickness transitions, and rib geometry in this virtual space, Ansix Tech eliminates guesswork and ensures the physical mold will produce perfect parts from its first test run. For multi-cavity medical molds—such as those for disposable laryngoscope blades—mold flow analysis is essential for optimizing gate locations and venting systems, ensuring consistent product quality across all cavities up to medical validation standards.

   

  “A proactive DFM is where cost savings are born,” explains Li Wei, Senior Project Manager at Ansix Tech. “By optimizing the gate location and cooling layout in the virtual stage, we prevent expensive mold modifications and material waste during trial runs”.

   

  Part IV: Material Selection – The Critical Intersection of Performance and Economy

  Material selection is one of the most critical and cost-sensitive decisions in medical injection molding. The choice of resin directly impacts part performance, regulatory compliance, sterilization compatibility, and total production cost. Ansix Tech’s expertise lies in guiding clients to the optimal balance between performance and economy, matching material grades to specific application requirements.

   

  Common Medical-Grade Plastics and Their Applications:
  
  

  For non-critical housings, standard PP can reduce unit costs by more than 50% compared to engineering polymers, while parts requiring autoclave sterilization demand high-heat materials such as PPS to prevent field failures and costly recalls. Medical-grade materials must meet stringent requirements for biocompatibility (ISO 10993), chemical resistance to disinfectants, and compatibility with various sterilization methods including gamma irradiation, ethylene oxide, and steam autoclave. For applications requiring exceptional transparency, Ansix Tech has successfully utilized materials such as styrene-acrylonitrile copolymer (SAN), selected for its predictable 0.4% shrinkage rate, good impact strength, and high modulus.

   

  Part V: Precision Mold Design – Engineering for High-Volume Production

  The core of Ansix Tech’s success lies in its mold-making prowess. For medical applications demanding micron-level precision and millions of production cycles, mold design must balance performance with practical manufacturability.

   

  Mold Steel Selection

  Steel selection directly impacts mold longevity, part quality, and maintenance intervals. Ansix Tech selects mold steels based on part complexity, production volume, and surface finish requirements. For cavity surfaces requiring mirror-like finishes—critical for transparent medical components—Ansix Tech specifies imported S136 mirror-polish steel for core inserts, heat-treated to 60-65 HRC, achieving surface roughness of Ra 0.4μm to ensure perfectly smooth, defect-free molded parts. For high-volume production molds destined for millions of cycles, H13 tool steel provides unparalleled durability in withstanding constant clamping pressure, abrasive plastic flow, and thermal cycling. For other structural plates, cost-effective pre-hardened steels such as 718 are used, demonstrating a smart allocation of resources.

   

  Cooling System / Water Channel Design

  Consistent cooling is paramount to prevent sink marks, warpage, and excessive cycle times—a direct driver of production efficiency and cost. For complex medical molds, Ansix Tech designs optimized conformal cooling systems that follow the contour of the part, eliminating hot spots that cause defects. A typical approach includes a series of baffle-cooled channels for complex core inserts and a double-layer circulatory system in the cavity plate. This uniform heat extraction minimizes cycle time and reduces warpage, increasing mold productivity significantly. Industry studies demonstrate that conformal cooling can reduce cycle time by up to 40% , increasing mold productivity by nearly 50% while improving part quality and reducing material waste.

   

  Runner and Gating System Design

  The runner and gating system determines how molten plastic is delivered from the injection molding machine nozzle to each cavity. For high-cavitation medical molds producing high volumes of small precision components, efficient runner design is essential to minimize material waste and ensure balanced cavity filling. Ansix Tech employs three-plate mold structures with pinpoint gates or hot runner systems where appropriate. For transparent medical components requiring flawless surfaces, pinpoint gates allow the runner system to be automatically separated, enabling fully automated production and eliminating gate vestige marks.

   

  Ejection System Design

  Clean, damage-free part ejection is critical for medical components where surface integrity cannot be compromised. For transparent parts that cannot bear witness marks from ejector pins, Ansix Tech employs full push-plate ejection systems. The plate contacts the entire underside of the part, distributing force evenly to prevent stress whitening or deformation during demolding. Strategic venting channels are machined around the cavity to allow trapped air to escape, preventing burns and voids.

   

  Mold Manufacturing Process and Machining Challenges

  The transformation of digital designs into hardened steel reality requires a sophisticated manufacturing workflow. Ansix Tech utilizes CNC milling, Electrical Discharge Machining (EDM), precision grinding, and wire EDM to achieve tolerances as tight as ±0.01mm. The typical mold manufacturing process involves:

   

  Soft turning and milling of mold components

   

  Heat treatment to achieve required hardness (typically 48-65 HRC)

   

  Hard milling of cavity and core surfaces

   

  EDM using graphite or copper electrodes for complex geometries and textures that cannot be machined directly

   

  Polishing and surface finishing to achieve required surface roughness for medical applications

   

  Final assembly of all mold components

   

  Key machining challenges in medical mold manufacturing include achieving micron-level tolerances for mating surfaces, maintaining consistent surface finishes across all cavities in multi-cavity molds, and ensuring perfect alignment between core and cavity halves. Ansix Tech’s 70% automated machining ratio and average mold trial of 2 times before production release demonstrate its manufacturing maturity and efficiency.

   

  Part VI: Rigorous Quality Validation – Ensuring Regulatory Compliance and Patient Safety

  For medical injection molding, quality is not an aspiration—it is a regulatory requirement enforced by ISO 13485:2016 and, where applicable, FDA 21 CFR Part 820. Ansix Tech’s complete quality control system, refined over nearly three decades, encompasses every stage from incoming material inspection to final product release.

   

  Process Validation – The IQ/OQ/PQ Framework

  Validation in medical molding is the link between precision engineering and patient safety—a disciplined, data-driven approach that defines quality at its source. Ansix Tech follows the established IQ/OQ/PQ validation framework:

   

  Installation Qualification (IQ): Verifying that the injection molding machine, mold, and auxiliary equipment are installed correctly according to manufacturer specifications

   

  Operational Qualification (OQ): Testing the process across the upper and lower operating limits to define the process window where parts consistently meet specifications

   

  Performance Qualification (PQ): Running the process at normal production parameters over an extended period to demonstrate long-term consistency and capability

   

  Validation provides objective evidence that the molding process is capable of consistently producing parts that meet all predetermined specifications—an essential requirement for medical device regulatory submissions.

   

  In-Process Quality Control

  During high-volume production, Ansix Tech implements real-time monitoring of critical process parameters including injection pressure, melt temperature, mold temperature, cooling time, and cavity pressure. Statistical process control (SPC) techniques are used to detect trends and prevent non-conforming parts. The company’s integrated quality management system provides full traceability from raw material lot to finished part serial number—a mandatory requirement for medical device supply chain compliance.

   

  Prototyping and Design Validation

  Before committing to production-grade tooling, Ansix Tech offers rapid prototyping services using advanced micro-additive manufacturing (Micro-AM) technologies for complex features. These functional prototypes undergo rigorous design validation including assembly tests, fit checks, and functional testing, de-risking projects before significant investment in production mold steel.

   

  Part VII: Injection Molding Process Optimization – Driving Efficiency and Cost Control

  Once the mold is qualified and validated, the focus shifts to optimizing the injection molding process for maximum efficiency and minimum cost per part—all while maintaining unwavering quality.

   

  Addressing Injection Molding Challenges for Medical Components

  Medical injection molding presents unique technical challenges beyond general-purpose molding. Thin-walled components for minimally invasive devices require high injection pressures and precise filling control. Transparent medical parts demand flawless surface finish with no flow marks, weld lines, or internal stresses. Components with living hinges must survive millions of flex cycles without failure. And all medical parts must maintain dimensional stability across different environmental conditions and sterilization methods.

   

  Ansix Tech addresses these challenges through:

   

  Scientific molding principles: Establishing a robust process window where the molding process is insensitive to normal material and environmental variations

   

  Design of Experiments (DoE): Systematically optimizing process parameters to identify the combination that produces the highest-quality parts most efficiently

   

  Advanced process monitoring: Real-time cavity pressure and temperature sensors provide feedback for closed-loop process control, ensuring each shot is consistent with the last

   

  Cycle Time Reduction Strategies

  Cycle time reduction is a primary lever for cost reduction in high-volume medical molding. Each second saved on cycle time multiplies across millions of shots into substantial savings. Ansix Tech’s cycle time optimization strategies include:

   

  Efficient cooling system design: Conformal cooling channels reduce cooling time—typically the longest phase of the injection molding cycle—by up to 40%

   

  Optimized filling and packing profiles: Reducing injection time without causing shear-induced degradation or flow marks

   

  Automated part handling: Robotics and conveyor systems remove parts and runners without operator intervention, reducing mold open time

   

  Hot runner systems: Eliminate runner scrap and reduce material consumption while shortening cycle times

   

  Material and Energy Efficiency

  Material cost typically represents 50-90% of total part cost in injection molding. Ansix Tech’s material optimization strategies include:

   

  Part design optimization: Removing unnecessary material through ribbed structures rather than solid walls, reducing weight per part

   

  Hot runner technology: Eliminating runner scrap entirely for high-volume applications

   

  Regrind strategies: For appropriate applications, recycling runner systems and non-conforming parts reduces raw material consumption

   

  Energy-efficient machinery: Modern servo-driven injection molding machines consume significantly less energy than conventional hydraulic machines

   

  Part VIII: Packaging and Rapid Delivery – Completing the Manufacturing Value Chain

  For medical device OEMs, supply chain reliability is as critical as product quality. Ansix Tech’s end-to-end manufacturing ecosystem includes packaging and logistics as integrated capabilities, not afterthoughts.

   

  Cleanroom-Compatible Packaging

  Medical components require packaging that maintains sterility, prevents damage during transit, and meets regulatory labeling requirements. Ansix Tech works with clients to develop packaging solutions that are:

   

  Cleanroom compatible: Suitable for ISO Class 7 or Class 8 cleanroom environments

   

  Protective: Preventing part damage or contamination during shipping

   

  Traceable: Barcode or RFID-labeled for lot tracking and inventory management

   

  Capacity and Delivery Assurance

  Ansix Tech’s 260 injection molding machines provide flexible capacity to scale from clinical trial quantities to millions of parts per month. For a typical multi-cavity disposable medical device mold, production capacity can reach 50,000+ units per month, with scalability to meet surge demand. The company maintains 99% on-time delivery performance with emergency response protocols for expedited orders.

   

  Global medical device OEMs require reliable, predictable supply chains capable of scaling to meet market demand. With four production bases across China and Vietnam, Ansix Tech offers geographic diversification and supply chain resilience. The company’s integrated model—from design through production and logistics—eliminates the communication gaps and handoff delays common in fragmented supply chains.

   

  Part IX: Delivering Customer Value Through Systematic Cost Reduction

  Across all phases of project execution, Ansix Tech’s primary value proposition is systematic cost reduction—not through corner-cutting, but through intelligent engineering, process optimization, and operational excellence.

  
  

  As Ansix Tech’s engineering philosophy demonstrates, true value in medical device manufacturing is not achieved by cutting corners, but through intelligent upfront engineering and total process integration. The company’s integrated ecosystem—uniting material science, digital engineering, precision tooling, and data-driven production—is fundamentally reshaping what is possible in medical device manufacturing economics.

   

  For non-critical medical housings, standard PP can reduce unit costs by more than 50% compared to engineering polymers, while parts requiring autoclave sterilization demand high-heat materials to prevent field failures and costly recalls. Through multi-cavitation strategies—packing 8, 16, 32, or more cavities into a single mold—Ansix Tech dramatically reduces per-part cycle time and manufacturing cost. Each additional cavity spreads the fixed mold cost across more parts, lowering the tooling cost contribution to each finished component.

   

  Conclusion: The Ansix Tech Advantage in Medical Mold Manufacturing

  Ansix Tech has established itself as a global leader in medical injection molding by delivering end-to-end integrated solutions that systematically reduce costs, accelerate time-to-market, and ensure uncompromising quality. With over 28 years of manufacturing heritage, more than 30,000 mold sets delivered, and a comprehensive ISO 13485-certified quality management system, the company offers medical device OEMs a strategic partnership rather than a transactional supplier relationship.

   

  From DFM analysis that captures 70% of manufacturing costs before tooling begins, to precision mold design featuring optimized cooling systems and ejection mechanisms, from rigorous quality validation meeting global regulatory standards to high-volume production with 99% on-time delivery, Ansix Tech demonstrates that uncompromising quality and significant cost reduction are not mutually exclusive goals—they are dual outcomes of intelligent, integrated manufacturing.

   

  For medical device manufacturers seeking a partner who can navigate the complexities of regulatory compliance, material science, precision engineering, and global supply chain logistics, Ansix Tech stands ready to deliver reliability, value, and performance from concept to delivery.

   

  *About Ansix Tech: Founded in 1998 in Hong Kong, Ansix Tech Limited is a global leader in injection molding solutions, specializing in the design and manufacturing of injection molds and injection-molded components for the medical device, automotive, consumer electronics, and industrial sectors. With four production bases, 260 injection molding machines, and ISO 13485:2016 certification, the company delivers end-to-end manufacturing solutions that drive customer success.

  
  

  Ansix Tech Co Ltd

  If you have any plans related to Medical mold manufacturing capabilities , you can contact us at any time. We will turn your ideas into reality, let you realize your dreams, and obtain large orders from the market. Our contact information is info@ansixtech.com. Or contact our CTO, mail: stephen@ansixtech.com 
  
  
  
  

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• The mold manufacturing process and product material selection
  

  The mold manufacturing process and product material selection of plastic products are key factors to ensure product quality and production efficiency.