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FDA/EC Compliant Injection Mold Steel
Discover FDA/EC compliant injection mold steel solutions at Zetar Mold, ensuring safety and quality in your manufacturing with reliable materials.
The Complete Guide to FDA/EC Compliant Injection Mold Steel Solutions
Defining FDA/EC Compliant Injection Mold Steel
FDA/EC compliant injection mold steel refers to specific grades of steel, or steels with particular surface treatments, that are deemed safe for use in manufacturing molds that produce parts coming into direct or indirect contact with food, beverages, medical devices, or pharmaceutical products.
1. Core Principles:
① Non-Toxicity: The steel must not release harmful substances into the products it helps create. Its constituents should not migrate into food or medical products in quantities that could endanger human health.
② Corrosion Resistance: High resistance to corrosion is paramount, preventing the formation of rust or other reaction products that could contaminate the molded parts. This is especially important when molding corrosive polymers or when molds are subjected to harsh cleaning agents or humid environments.
③ Inertness: The steel should not cause an unacceptable change in the composition of the food or medical product, nor should it deteriorate its organoleptic characteristics (taste, smell).
④ Cleanability: The mold surface must be capable of being easily and effectively cleaned and, where necessary, sterilized to prevent microbial contamination. This often implies a high-quality polish.
2. Basic Concepts:
① FDA Compliance: In the United States, the FDA regulates materials that come into contact with food under Title 21 of the Code of Federal Regulations (CFR). While the FDA doesn't typically "approve" mold steels directly, materials used must be "Generally Recognized As Safe" (GRAS) or meet specific requirements for food contact substances (FCS). Stainless steels are often preferred due to their inertness and corrosion resistance.
② EC Compliance: In the European Union, Regulation (EC) No 1935/2004 is the framework regulation for food contact materials (FCMs). It stipulates that materials must not transfer their constituents to food in quantities that could endanger human health, change food composition unacceptably, or deteriorate its organoleptic properties. For metals and alloys, specific measures are less harmonized across the EU than for plastics, but general safety requirements apply, and national legislation or industry standards (like those from the Council of Europe) often provide guidance. Good Manufacturing Practice (GMP) as per Regulation (EC) No 2023/2006 is also crucial.
Classification and Types of Compliant Mold Steels
FDA/EC compliant mold steels can be classified based on various criteria, helping manufacturers select the most suitable option for their specific needs.
1. By Material Composition:
① Stainless Steels:
• Austenitic Stainless Steels (e.g., AISI 304, 316, 316L): Offer excellent corrosion resistance and good formability but generally lower hardness unless cold-worked. 316/316L grades are often preferred for higher corrosion resistance, especially against chlorides.
• Martensitic Stainless Steels (e.g., AISI 420, modified 420, 440B/C): Can be heat-treated to achieve high hardness and wear resistance, making them suitable for cutting edges or high-wear areas in molds. They offer good corrosion resistance, though generally less than austenitic grades. Grades like Uddeholm Stavax ESR (modified 420) are specifically designed for molds requiring high polishability and corrosion resistance.
• Precipitation Hardening (PH) Stainless Steels (e.g., 17-4 PH): Combine good corrosion resistance with high strength and hardness, achievable through a single, low-temperature heat treatment.
② Specialty Tool Steels (with compliant characteristics or coatings): Some through-hardened or case-hardened tool steels might be used if their composition is inherently safe or if they are treated with FDA/EC compliant surface coatings (e.g., certain PVD coatings like TiN or CrN if certified). The base material’s leachability is a key factor.
2. By Corrosion Resistance Level:
① General Purpose Corrosion Resistance: Suitable for less aggressive polymers and environments (e.g., some 400-series stainless steels).
② High Corrosion Resistance: Essential for molding aggressive polymers (e.g., PVC, flame-retardant plastics that release corrosive gases) or for molds operating in humid/condensing environments or subject to frequent, aggressive cleaning (e.g., 316L, specialized martensitic grades like Stavax ESR).
3. By Hardness and Wear Resistance:
① Lower Hardness Steels: Easier to machine but may offer shorter mold life for abrasive materials or high-volume production (e.g., annealed austenitic stainless steels).
② High Hardness Steels: Provide excellent wear resistance and mold longevity but can be more challenging to machine and polish (e.g., hardened martensitic stainless steels).
4. By Regulatory Focus (though often overlapping):
① Steels Primarily Meeting FDA Guidelines: Often selected based on historical use, GRAS status, and supplier certifications for food contact.
② Steels Primarily Meeting EC Regulations: Selected based on compliance with (EC) 1935/2004 and relevant specific measures or national guidelines, often requiring a Declaration of Compliance (DoC) from the supplier.
Note: Many high-quality stainless steels will inherently meet the requirements of both FDA and EC guidelines due to their inert nature and corrosion resistance.
Typical Application Scenarios and Use Cases
FDA/EC compliant mold steels are indispensable in industries where product safety and hygiene are non-negotiable.
1. Food and Beverage Packaging:
① Containers and Lids: Injection molds for producing yogurt cups, butter tubs, food trays, caps, and closures. Steel must resist corrosion from food acids and cleaning agents.
② Cutlery and Utensils: Molds for disposable or reusable plastic cutlery.
③ Example: A dairy company requires molds for PP (polypropylene) yogurt cups. A martensitic stainless steel like modified AISI 420 is chosen for its good polishability (for easy part release and hygiene) and corrosion resistance against potential lactic acid residues and cleaning solutions.
2. Medical Devices:
① Surgical Instruments and Components: Molds for disposable surgical tools, diagnostic device components, and drug delivery systems (e.g., inhaler parts, syringe components).
② Implantable Device Molds (indirect): While the final implant might be silicone or PEEK, the molds for these components must meet stringent cleanliness and non-contamination standards.
③ Example: Manufacturing molds for polycarbonate (PC) housings for blood analysis equipment. A high-purity, corrosion-resistant stainless steel like Uddeholm Corrax (a PH stainless steel) might be selected for its excellent dimensional stability, corrosion resistance, and ease of cleaning, critical for preventing cross-contamination.
3. Pharmaceutical Packaging:
① Tablet Blister Pack Molds: Molds for forming cavities in pharmaceutical blister packaging.
② Vial Caps and Closures: Precision molds for ensuring seal integrity and non-contamination of sterile products.
③ Example: Molds for HDPE (high-density polyethylene) caps for medicine bottles. A steel like 316L stainless might be used where resistance to specific chemicals or sterilization methods is paramount.
4. Baby Products:
① Feeding Bottles, Nipples, Pacifiers: Molds for items that come into direct oral contact with infants.
② Toys Intended for Mouthing: Where plastic components are injection molded.
③ Example: Molds for silicone baby bottle nipples. The mold steel must be highly polishable for a smooth surface finish on the silicone part and must not leach any harmful substances. A high-quality stainless steel is essential.
5. Cosmetics Packaging:
Containers for Creams and Lotions: Molds for jars, tubes, and dispensers where product purity is important.
6. Silicone Product Manufacturing:
Many silicone products, especially medical-grade and food-grade (e.g., bakeware, seals, tubing), are injection molded. The mold steel must be compatible with silicone processing (often high temperatures) and ensure the purity of the final silicone part. High polishability is also critical for easy release of silicone parts.
Advantages of FDA/EC Compliant Mold Steels
Using compliant mold steels offers significant benefits beyond just meeting regulations.
1. Enhanced Product Safety: Minimizes the risk of harmful substances migrating from the mold to the product, protecting consumer health.
2. Regulatory Compliance: Ensures adherence to stringent FDA and EC regulations, avoiding legal issues, fines, and product recalls.
3. Brand Protection and Reputation: Demonstrates a commitment to quality and safety, enhancing brand trust and consumer confidence.
4. Improved Product Quality: Corrosion resistance prevents rust and other contaminants from marring the surface of molded parts, leading to higher aesthetic quality and fewer rejects.
5. Extended Mold Life in Specific Environments: Resistant to corrosive polymers (e.g., PVC, some flame retardants) and aggressive cleaning agents, leading to longer operational life for the mold.
6. Reduced Contamination Risk: Smooth, highly polishable surfaces inherent in many compliant steels are easier to clean and less prone to harboring bacteria or residues.
7. Market Access: Compliance is often a prerequisite for selling products in major markets like the USA and Europe.
Disadvantages and Limitations of FDA/EC Compliant Mold Steels
While highly beneficial, these specialized steels also come with certain considerations.
1. Higher Material Cost: Compliant steels, particularly high-chromium stainless steels and specialty grades, are generally more expensive than standard tool steels like P20 or H13.
2. Machinability Challenges: Some stainless steels, especially austenitic grades, can be more difficult to machine (e.g., work hardening, lower thermal conductivity) compared to conventional mold steels, potentially increasing fabrication time and cost.
3. Lower Thermal Conductivity: Many stainless steels have lower thermal conductivity than standard tool steels. This can impact cycle times in injection molding, requiring careful mold design with optimized cooling channels.
4. Hardness Limitations (for some grades): Austenitic stainless steels (e.g., 304, 316) cannot be hardened by heat treatment and offer lower wear resistance than hardened tool steels, making them less suitable for highly abrasive materials unless specific surface treatments are applied. Martensitic grades overcome this but may have slightly lower corrosion resistance than the best austenitic grades.
5. Specific Welding Requirements: Repairing or modifying molds made from stainless steels often requires specialized welding procedures and filler materials to maintain corrosion resistance and structural integrity.
6. Potential for Galling: Some stainless steels are prone to galling (a form of wear caused by adhesion between sliding surfaces) if not properly lubricated or if component design doesn’t account for this.
Brief Comparison with Non-Compliant Steels
Non-Compliant Steels (e.g., P20, H13 – when uncoated and directly contacting food/medical products):
① Advantage: Lower cost, generally better machinability, higher thermal conductivity, good hardness and toughness.
② Disadvantage: Prone to corrosion, potential for leaching of alloying elements (e.g., chromium, molybdenum, vanadium in non-stabilized forms) into products, not suitable for direct food/medical contact without compliant coatings, risk of regulatory non-compliance and product recalls.
Comparison Summary:
The primary driver for choosing FDA/EC compliant steels is safety and regulatory necessity. While they may present cost and manufacturing challenges, these are often outweighed by the imperative to protect consumer health and comply with legal standards in sensitive applications. Non-compliant steels are suitable for many general-purpose molding applications but pose unacceptable risks for food, medical, or pharmaceutical products.
Guide to FDA/EC Compliant Injection Mold Steels
Learn selection, applications, technical specs, and best practices for safe food & medical parts.
The Complete Guide to FDA/EC Compliant Injection Mold Steel Solutions
Key Characteristics and Properties of Compliant Steels
The performance of a compliant mold steel is dictated by several critical characteristics:
1. Corrosion Resistance:
① Mechanism: Primarily achieved through the addition of chromium (typically >12%), which forms a passive, tenacious, and self-repairing chromium oxide (Cr₂O₃) layer on the steel's surface. Molybdenum (Mo) further enhances resistance, especially against pitting and crevice corrosion caused by chlorides.
② Importance: Prevents rust formation that can contaminate parts, alter surface finish, and block cooling channels. Crucial for molding corrosive resins (e.g., PVC, acetals with certain additives) or when molds are exposed to humid environments or sterilizing chemicals.
③ Measurement: Often evaluated by salt spray tests (ASTM B117), resistance to specific chemicals, or electrochemical testing. Pitting Resistance Equivalent Number (PREN = %Cr + 3.3 * %Mo + 16 * %N) is a common indicator for stainless steels.
2. Hardness and Wear Resistance:
① Mechanism: Achieved through alloying elements (like carbon in martensitic stainless steels) and heat treatment (quenching and tempering) or precipitation hardening.
② Importance: Determines the mold's ability to withstand abrasive wear from filled plastics (e.g., glass-filled polymers), sliding action of mold components, and indentations. Directly impacts mold life and maintenance intervals.
③ Typical Values: Martensitic stainless steels (e.g., modified 420) can achieve 48-54 HRC. PH stainless steels can also reach high hardness levels. Austenitic grades are softer (typically <30 HRC in annealed state).
3. Machinability:
① Factors: Influenced by hardness, toughness, work-hardening tendency, and thermal conductivity. Stainless steels, particularly austenitic grades, are known for being "gummy" and having a high work-hardening rate, requiring specific tooling, cutting speeds, and feeds. Resulphurized grades (e.g., 303) offer improved machinability but may have slightly reduced corrosion resistance and are not always preferred for high-purity applications.
② Importance: Impacts the cost and time required for mold fabrication.
4. Polishability:
① Factors: Depends on steel cleanliness (low inclusions), homogeneity, and hardness. Specialized manufacturing processes like Electro-Slag Remelting (ESR) are used to produce cleaner steels (e.g., Stavax ESR) with excellent polishability.
② Importance: Crucial for achieving high-gloss part finishes, ensuring easy part ejection, and enhancing cleanability for hygiene. Medical and optical applications often demand SPI A1 or A2 finishes.
5. Weldability:
① Factors: Varies significantly between steel types. Austenitic stainless steels are generally weldable. Martensitic stainless steels require pre-heating, specific filler materials, and post-weld heat treatment to restore properties and prevent cracking.
② Importance: Essential for mold repair or modification. Improper welding can compromise corrosion resistance and mechanical properties in the heat-affected zone.
6. Thermal Conductivity:
① Values: Stainless steels typically have lower thermal conductivity (e.g., 15-25 W/m·K) compared to common tool steels like P20 (~29-34 W/m·K) or H13 (~25 W/m·K), and significantly lower than copper alloys used for inserts (~200-380 W/m·K).
② Importance: Affects mold heating and cooling efficiency, which can impact cycle times and part quality (e.g., warpage, sink marks). Mold designs may need more extensive or strategically placed cooling channels.
7. Dimensional Stability:
① Factors: Resistance to distortion during heat treatment and under cyclic thermal loading during molding.
② Importance: Critical for maintaining tight tolerances in precision molds over long production runs. PH stainless steels often exhibit good dimensional stability due to lower temperature hardening processes.
8. Purity and Homogeneity:
① Factors: Achieved through advanced steelmaking processes (e.g., ESR, Vacuum Arc Remelting - VAR). Reduces non-metallic inclusions (sulfides, oxides, silicates).
② Importance: Enhances polishability, toughness, fatigue strength, and corrosion resistance. Crucial for high-performance molds.
Core Selection and Validation Process for Compliant Mold Steels
Rather than a “working principle” of the steel itself, the critical process involves selecting and validating the steel for a compliant application.
1. Define Application Requirements:
① Identify the end-product (food container, medical device, etc.).
② Determine the specific regulatory landscape (FDA, EC, specific directives/standards).
③ Specify the polymer to be molded (type, fillers, additives, potential for corrosive outgassing).
④ Define expected production volume, mold life, and required part quality (surface finish, tolerances).
2. Initial Material Screening:
① Consult supplier datasheets and certifications for FDA/EC compliance statements or suitability for food/medical contact.
② Prioritize stainless steel grades known for their inertness and corrosion resistance (e.g., 316L, modified 420 grades, PH stainless steels).
③ Consider the mechanical properties needed (hardness, wear resistance) based on the polymer and production volume.
3. Detailed Evaluation of Steel Properties:
① Corrosion Resistance: Match the steel's corrosion profile to the polymer, cleaning agents, and operating environment.
② Machinability & Polishability: Assess if the required surface finish can be achieved cost-effectively.
③ Wear Resistance: Ensure suitability for abrasive materials, if any.
④ Thermal Properties: Consider impact on cycle time and design cooling accordingly.
4. Supplier Verification and Documentation:
① Request a Declaration of Compliance (DoC) from the steel supplier, especially for EC markets. This document should state conformity with relevant regulations (e.g., (EC) 1935/2004).
② Ensure full material traceability (heat numbers, batch certifications).
③ Verify any claims of FDA compliance (e.g., material listed as GRAS, or meets 21 CFR requirements for specific applications).
5. Mold Design Considerations:
① Design for cleanability: avoid sharp internal corners, dead spots; specify appropriate radii.
② Ensure adequate cooling to compensate for lower thermal conductivity if applicable.
③ Select appropriate surface finish specifications.
6. Mold Manufacturing and Surface Treatment:
① Use appropriate machining techniques for the selected steel.
② If coatings are used, ensure the coating material itself is FDA/EC compliant for the intended application.
③ Achieve the specified polish level meticulously.
7. Validation and Testing (Potentially):
① For critical applications, migration testing on the final molded part may be required to confirm that no unintended substances are leaching from the mold (via the part) in quantities exceeding regulatory limits. This is typically the responsibility of the food/medical device manufacturer, but the mold material is a key input.
② Perform functional mold trials to ensure performance.
8. Establish Cleaning and Maintenance Protocols:
Develop and document procedures for cleaning and maintaining the mold using compliant cleaning agents and methods that do not compromise the steel's surface or compliance.
Key Considerations in Implementation and Use
Several critical factors must be managed when working with FDA/EC compliant mold steels:
1. Regulatory Specifics:
① FDA : Primarily 21 CFR Part 177 (Indirect Food Additives: Polymers) and Part 178 (Indirect Food Additives: Adhesives and Components of Coatings). Stainless steel is generally recognized as safe (GRAS) under 21 CFR 182/184 for many food contact applications if formulated correctly.
② EC : Regulation (EC) No 1935/2004 (Framework), Regulation (EC) No 2023/2006 (Good Manufacturing Practice - GMP). For metals, specific harmonized EU measures are lacking, so national laws (e.g., German BfR recommendations) or Council of Europe guidelines on metals and alloys used in food contact materials are often referenced. A Declaration of Compliance is key.
2. Material Certification and Traceability:
Always demand and retain mill certificates and supplier declarations of compliance. Traceability by heat number is essential for quality control and recall management.
3. Mold Design for Cleanability:
This cannot be overstated. Molds must be designed to be easily and thoroughly cleaned. This includes:
① Generous radii in corners.
② Avoiding undercuts or features that trap material.
③ High-quality surface finishes (SPI A2 or better often preferred).
④ Easy disassembly for cleaning if required.
4. Surface Finish Requirements:
Medical and food applications often require very smooth surfaces (e.g., Ra < 0.4 µm or better) to prevent microbial adhesion and facilitate cleaning. The chosen steel must be capable of achieving and maintaining this finish.
5. Impact of Processing Polymers:
Certain polymers (e.g., PVC, POM, some flame-retardant grades) can release corrosive byproducts (e.g., HCl, formaldehyde) during molding, especially at elevated temperatures or if residence times are too long. The mold steel must be able to withstand these chemicals.
6. Maintenance and Cleaning Protocols:
① Use cleaning agents compatible with the specific grade of stainless steel. Avoid chlorides (unless the steel is highly resistant like 316L or specialized grades) and harsh abrasives that could damage the passive layer or surface finish.
② Regular cleaning schedules are vital to prevent buildup of residues.
③ Passivation (a chemical treatment to enhance the passive layer) may be necessary after machining, welding, or if the surface becomes contaminated.
7. Cost vs. Risk Assessment:
The higher initial cost of compliant steels must be weighed against the significant risks of non-compliance, including product recalls, legal penalties, brand damage, and potential harm to consumers.
Design and Implementation Guide for Compliant Molds
1. Steel Selection Best Practices:
① Prioritize Stainless Steel: For most FDA/EC applications, stainless steel is the default choice.
② Match Corrosion Resistance to Application:
• For general food/medical parts with non-aggressive polymers: Modified 420 stainless (e.g., Stavax ESR, Moldmax HH with appropriate handling) can be excellent.
• For aggressive polymers (PVC, flame retardants) or high humidity/sterilization: Higher alloyed stainless steels like AISI 316L, Uddeholm Corrax, or equivalent grades with superior pitting and crevice corrosion resistance are recommended.
③ Consider Hardness Needs: For abrasive resins or long runs, choose a hardenable grade (martensitic or PH stainless). For simpler parts with non-abrasive resins, austenitic grades might suffice if cycle time isn’t critically impacted by their lower thermal conductivity.
④ Verify Supplier Documentation: Always insist on certificates of conformity and material test reports.
2. Mold Design Best Practices:
① Radii and Draft Angles: Incorporate generous radii in all internal corners (minimum 0.5mm, preferably larger) to facilitate cleaning and reduce stress concentrations. Ensure adequate draft angles for easy part ejection.
② Surface Finish: Specify the highest practical surface polish (e.g., SPI A2/A1, Diamond polish) on cavity surfaces. This aids part release, enhances cleanability, and reduces microbial adhesion.
③ Venting: Ensure adequate venting to prevent gas traps, which can lead to part defects and require aggressive cleaning.
④ Cooling System Design: Account for the lower thermal conductivity of stainless steels. Optimize cooling channel layout, diameter, and proximity to the cavity surface. Consider conformal cooling for complex parts.
⑤ Avoid Dead Spots: Design out areas where material or cleaning fluids can stagnate.
⑥ Material Flow: Ensure smooth material flow paths to prevent degradation and make cleaning easier.
3. Machining and Polishing Techniques:
① Tooling: Use sharp, positive rake cutting tools, preferably coated grades designed for stainless steels.
② Cutting Parameters: Employ appropriate speeds and feeds. Lower speeds and higher feeds are often used for austenitic stainless steels to avoid work hardening. Use ample coolant.
③ Polishing: Use a systematic approach, progressing through finer abrasive grits. Ensure each grit completely removes marks from the previous stage. For high-purity steels (ESR/VAR grades), achieving a mirror finish is easier. Avoid cross-contamination from tools used on carbon steels.
4. Mold Assembly and Handling:
① Maintain cleanliness throughout the assembly process.
② Use appropriate, compliant lubricants for moving parts if necessary, ensuring they are suitable for the application (e.g., food-grade H1 lubricants).
5. Post-Fabrication Treatment:
Passivation: Consider passivating stainless steel molds after all machining, grinding, and polishing operations, especially if any free iron contamination from tooling might have occurred. This chemical process (typically using nitric acid or citric acid solutions) removes free iron and enhances the natural chromium oxide passive layer, maximizing corrosion resistance.
Common Problems and Solutions with Compliant Mold Steels
Even with careful selection, challenges can arise.
1. Unexpected Corrosion or Staining:
Cause: Incorrect steel grade for the polymer/environment, aggressive cleaning agents (especially chloride-containing), contamination from carbon steel tooling, breakdown of passive layer, crevices.
Solution:
① Verify steel grade suitability. Upgrade if necessary.
② Use only recommended, chloride-free cleaning agents.
③ Ensure proper passivation after machining or repair.
④ Thoroughly clean and dry molds after use.
⑤ Redesign to eliminate crevices if they are the source of crevice corrosion.
2. Difficulty Achieving/Maintaining High Polish:
Cause: Steel grade not suitable for high polish (high inclusions), improper polishing technique, surface damage during handling or cleaning.
Solution:
① Select high-purity ESR/VAR grade steels for mirror finishes.
② Train personnel in correct polishing techniques for stainless steel.
③ Implement careful handling procedures. Use soft tools for cleaning.
④ Consider compliant hard coatings (e.g., CrN) to protect the polish on softer stainless grades.
3. Premature Wear with Abrasive Materials:
Cause: Selected steel lacks sufficient hardness/wear resistance for glass-filled or mineral-filled polymers.
Solution:
① Switch to a harder, wear-resistant compliant steel (e.g., hardened martensitic stainless, PH stainless).
② Consider FDA/EC compliant PVD coatings (e.g., specific grades of TiN, CrN, DLC) over a suitable stainless steel substrate.
③ Optimize gate design and flow paths to minimize abrasive wear.
4. Longer Cycle Times
Cause: Lower thermal conductivity of stainless steel compared to standard tool steels.
Solution:
① Optimize cooling channel design (closer to cavity, increased flow, conformal cooling).
② Consider using high-conductivity inserts (e.g., beryllium-free copper alloys, if their surface can be made compliant or if they don’t contact the product) in critical areas, ensuring they are also compliant or isolated.
③ Adjust processing parameters carefully.
5. Galling of Mold Components:
Cause: Common with stainless-on-stainless sliding contact under high load without adequate lubrication.
Solution:
① Use dissimilar stainless steel grades for mating components if possible.
② Apply compliant anti-galling surface treatments or coatings.
③ Ensure proper lubrication with FDA/EC compliant lubricants (e.g., H1 food-grade).
④ Improve surface finish and design for clearances.
6 Issues with Welding/Repair:
Cause: Incorrect welding procedure, wrong filler material, lack of pre/post-heat treatment for martensitic grades.
Solution:
① Follow steel supplier’s welding recommendations strictly.
② Use matching or recommended filler materials.
③ Perform necessary pre-heating and post-weld heat treatment to restore mechanical properties and corrosion resistance.
④ Passivate weld area after repair.
Design Checklist/Decision Aid for Selecting Compliant Steel
This simplified checklist can guide the initial selection process:
1. Application & Regulatory Requirements:
① Food Contact? (Specify type of food, contact duration/temperature).
② Medical Device? (Specify class, contact type – e.g., external, internal).
③ Pharmaceutical? (Specify application).
④ Applicable Regulations: FDA (21 CFR parts?), EC (1935/2004, GMP?), Other (National laws, specific standards)?
⑤ Declaration of Compliance required?
2. Polymer to be Molded:
① Polymer Type (e.g., PP, PE, PC, PET, PVC, POM, Silicone, TPE)?
② Additives (e.g., Glass fibers, flame retardants, colorants)?
③ Corrosive Outgassing Potential? (Yes/No/Potentially)
3. Mold & Production Requirements:
① Expected Production Volume (Low/Medium/High)?
② Required Mold Life?
③ Required Surface Finish (e.g., SPI C1, B2, A2, Optical)?
④ Critical Tolerances?
⑤ Complexity of Mold Design?
4. Steel Property Considerations:
① Corrosion Resistance Level Needed (Standard/High/Very High)?
② Hardness/Wear Resistance Needed (Low/Medium/High)?
③ Machinability Concerns? (Budget/Time constraints).
④ Polishability to required level achievable?
⑤ Thermal Conductivity Impact on Cycle Time (Acceptable/Needs Mitigation)?
5. Supplier & Cost:
① Availability of Certified Compliant Grades?
② Supplier Reliability and Technical Support?
③ Budget Constraints (Balance cost vs. risk and performance)?
④ Traceability Assured?
Decision Tip: When in doubt, err on the side of higher corrosion resistance and consult with reputable steel suppliers who specialize in materials for regulated industries. Always prioritize safety and compliance.
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