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The performance of your product is directly related to the quality and reliability of the seal. Our solutions help companies perform better and reduce warranty risk. Our seals enable market beating performance for some of the world’s most well-known brands. We build value, we ship value, we enable your success.

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Materials are available in most polymer family types formulated to meet regulatory requirements and industry standards including FDA A-F, USP VI, 3A c.1, WRAS, ADI

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  • Note re FDA: Food and Drug Administration
  • US administrative law, Code of Federal Regulations Title 21
  • Note re FDA: Food and Drug Administration
  • Regulation: responsibility for demonstration of compliance with CFR 21.177.2600 lies with the rubber manufacturer
  • Paragraph A-D List the ingredients and quantitative limits (only suitable for Dry Foods)
  • Paragraph A-F Suitable in Dry Aqueous and Fatty
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Checklist

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Checklist

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PPAP 18 Elements

  1. Design Records: A copy of the drawing or model provided by customer.
  2. Engineering Change Documents: Detailed description of changes of parts from previous revisions called Engineering Change Notice.
  3. Customer Engineering Approval: Customer approval of sample production parts.
  4. Design Failure Mode and Effects Analysis (DFMEA): Prediction of a product's potential design failure.
  5. Process Flow Diagrams: All steps in manufacturing process including components, measurement, and inspection.
  6. Process Failure Mode and Effects Analysis (PFMEA): Prediction of a potential process failure that could occur during production.
  7. Control Plan: Details the plan for how quality will be implemented to ensure a stable and reliable process.
  8. Measurement System Analysis (MSA): Conformance to customer’s ISO or TS standard. Usually Gage R&R for critical impact characteristics to control repeatability and reproducibility and confirmation that gages are calibrated to measure these characteristics to control measurement bias.
  9. Dimensional Results: A list of every dimension noted on the ballooned drawing or model with pass/fail assessment.
  10. Material / Performance Test Results: Summary of every test performed on the part, usually in the form of DVP&R (Design Verification Plan and Report).
  11. Initial Process Studies: Shows that critical processes are reliable. Includes SPC (statistical process control) charts.
  12. Qualified Laboratory Documentation: All industry certifications for validation testing.
  13. Appearance Approval Report (AAR): Customer approval on final product appearance including color, texture, fit, and more.
  14. Sample Product: Sample from initial production run.
  15. Master Sample: Sample part signed off by customer and supplier.
  16. Checking Aids: Detailed list of all tools used to inspect and measure parts.
  17. Records of Compliance with Customer-Specific Requirements: List of customer’s specific requirements for PPAP process.
  18. Part Submission Warrant (PSW): Summary of entire PPAP submission.

 

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Purpose of PPAP Summary

  1. Validating supplier’s ability. Ability to meet customer and regulatory requirements.
  2. Understanding customer requirements.
  3. Establishing a reliable and repeatable process that won’t change without further customer approval.
  4. Reducing cost and having faster time to market.
  5. Maintaining expectations & compliance on both sides.

PPAP is typically required when:

  1. A new part or product.
  2. Product changes/corrections: design, materials, supply, and function.
  3. Process changes/corrections: method, tools, location, and inspection criteria.
  4. Inactive tooling for more than one year.

PPAP 5 Levels of Submission:

The PPAP report has 5 levels of submissions with Level 3 as the default level of PPAP submission approval.

  1. Level 1: Part Submission Warrant (PSW) only submitted to the customer.
  2. Level 2: PSW with product samples and limited supporting data.
  3. Level 3: PSW with product samples and complete supporting data.
  4. Level 4: PSW and other requirements as defined by the customer.
  5. Level 5: PSW with product samples and complete supporting data available for review at the supplier’s manufacturing location.

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Certifications

certification
Certificate Title

Darcoid achieved IATF 16949 certification in May 2021. This replaces and supersedes the ISO 9001 registration we have maintained since 2002. Darcoid was an early adopter of the ISO standard. We were quick to realize the benefits of following what has now become a widely adopted standard which places such a strong emphasis on process conformity and continuous improvement.

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aerospace-military

Aerospace / Military

The global Aerospace and Defense market equipment that moves todays industry is more reliable and highly engineered than ever before. This equipment uses technologically advanced sealing devices and materials that can keep pace with extremely high temperatures, and high and low pressures with aggressive chemicals.

We understand the specific needs the Aerospace industry is required to meet and offer a wide range of seals manufactured in a range of compounds that have the necessary industry approvals and ever increasing requirements for certification including - Military Specification MIL, MS, AS9100, AN, MOD, ISO14001, ASTM, SAE.

With our ISO Certified Quality Department and our experienced Supply Chain team you can count on Darcoid to deliver quality product that meet or exceed the Aerospace industries high performance standards.

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life-sciences

Life Sciences

The life science market includes companies with very diverse manufacturing outputs. From biopharma processing to medical devices, we offer products that meet the exacting requirements of both. Darcoid"s focus on sealing products and elastomeric components and with knowledge of MRO spares, we can provide the necessary support to your business. We can support from concept to finished medical device or provide products for planned downtime.

Products for Medical Device OEM’s

Individual components can be produced in a wide variety of thermoplastic resins and elastomeric compounds. Available thermoplastic resins include everything from common plastics (e.g. PVC, ABS) to extreme plastics (e.g. PEEK). Elastomeric compounds include organic compounds such as EPDM, Nitrile & Viton as well as a variety of silicones. Depending on the silicone choice, manufacturing processes include compression, injection, transfer, and liquid injection (aka LIM). Our offering includes materials approved by one or more governing bodies such as UL, FDA Title 21 (Part 177.2600), USP Class VI, USP 87, ISO 10993-5 and ISO10993-10. Both thermoplastic and elastomeric products can be made homogenously or can incorporate inserts of plastic or metal.

Products for Pharma Processing

Our offering includes materials approved by one or more governing bodies such as UL, FDA Title 21 (Part 177.2600), USP Class VI, USP 87, ISO 10993-5 and ISO10993-10.

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(Darcoid) is the gold standard with respect to structuring a supplier/customer partnership. I can’t think of anyone who does it better. (Their) consistent support, honesty, insights, and ethics are all deeply appreciated. (We) need more relationships like this. It’s like having an “Easy Button”.
I’ve worked with Bill (Killian) for almost 10 years now. Bill has every quality you look for .. Honest communication, prompt service, and general availability are at the top of his priorities. Bill has helped us navigate line down situations in a tactical sense as well as strategically plan out next generation products. .. he is always the first call I make
Darcoid has several strong points that I have personally benefitted from and experienced over the years. One of the best technical support of materials and sealing designs. Excellent new product launch and prototype support ... Having local inventory continues to our best defense against purchasing and planning short coming ...no other vendor comes close.
Knowledge of the seal industry is invaluable when … additional supply chains are required to support our growing production … Darcoid (is) clearly committed to …our reputation for performance, innovation, and reliability.
I’m always looking forward to working with Darcoid.  They are extremely responsive, friendly to work with and committed to meeting our sealing requirements no matter how challenging they are.  .. their expertise has been critical to the success of our projects.  They understand and mirror our passion for performance … a key partner for future development.

Testimonials

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FAQ

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