Understanding Cleanroom Assembly Services for Medical Device Manufacturing

In medical device and security manufacturing, foreign material can compromise biocompatibility and lead to costly scrap or even recalls. Choosing a manufacturing partner with proven cleanroom capabilities is essential for regulatory compliance and consistent product performance. ProMed’s cleanroom assembly services support precision molding and assembly, ensuring that components meet the strict standards required for medical, pharmaceutical, and security applications.

 

Cleanroom standards: ISO classification and requirements

Cleanroom environments provide the controlled conditions necessary for contamination-sensitive production of medical devices, implantable components, and pharmaceutical products. Understanding these standards helps you evaluate manufacturing partners and ensure regulatory compliance.

 

ISO 14644-1 standards, particle control, and class specifications

The ISO 14644-1 standard sets cleanroom classifications based on allowable particle counts per cubic foot, focusing on particles ≥0.5 microns. These limits directly affect product sterility and overall quality.

Class 7 specifications (formerly Class 10,000):

• Maximum of 10,000 particles per cubic foot
• 60 to 90 air changes per hour
• HEPA filtration with 99.99% efficiency at 0.3 microns
• Suitable for medical component assembly, pharmaceutical packaging, and combination products
• Required for direct patient-contact devices, implantables, and sterile applications

Clean room environments provide contamination control and support production of components where cleanliness and precision are critical.

 

Material selection and design for manufacturability in cleanroom environments

Successful cleanroom production relies on thoughtful material choices and design optimization. ProMed applies 30+ years of experience to guide decisions that ensure manufacturability and regulatory compliance.

 

Biocompatible silicone elastomer selection

LSR (Liquid Silicone Rubber) provides precise flow for complex geometries with durometer ranges of 10 to 80 Shore A. HCR (High Consistency Rubber) suits larger parts and higher-volume runs with similar flexibility.

All materials meet USP Class VI and ISO 10993 standards, with traceability and sterilization compatibility for gamma, EtO, and autoclave methods.

 

Design for manufacturability

Early design review and prototyping validate materials and geometry, reducing iteration and contamination risk. Focus areas include wall thickness uniformity, surface finish for cleanability, and self-locating features that support automated assembly. Dimensional tolerances typically range from ±0.003″ to ±0.005″.  Tighter tolerances are sometimes used, but come with trade offs in production yields, manufacturability, and cost. 

 

Integrated cleanroom molding and assembly processes

ProMed combines high-precision molding and advanced cleanroom assembly in a single facility, reducing vendor handoffs and maintaining strict quality control throughout production.

 

Precision molding, assembly operations, and surface treatment technologies

ProMed’s cleanroom capabilities combine precision molding, multi-material overmolding, assembly, and surface treatments to meet tight tolerances and sterility standards:

• High-precision injection molding: Equipment ranges from 11- to 240-ton presses with shot sizes from 0.5 ccm to 180 ccm. Geometric tolerances, typically from ±0.003″ to ±0.005″, are supported. Statistical process control ensures consistency, and micro-molding produces ultra-small parts for catheters, implantable devices, and ophthalmic implants.
• Multi-component and overmolding: Two-shot molding integrates multiple materials, including silicone over PEEK, polysulfone, stainless steel, nitinol, titanium, and PCBs, reducing post-mold operations.
• Advanced assembly operations: Heat-curable and RTV adhesives secure sensitive substrates. Plasma etching prepares low-energy surfaces, and priming solutions handle challenging combinations. Metal insert welding ensures mechanical strength and electrical reliability.
• Device assembly and packaging: ProMed assembles subassemblies, dosage forms into applicators, and subcutaneous or intrauterine products with precise alignment. Controlled primary packaging maintains sterility. Capabilities cover delicate ophthalmic implants to larger intrauterine devices.
• Quality control: Defined checkpoints and release criteria verify accuracy at every stage. Automated optical inspection and magnification detect defects early, while bond strength and functional testing confirm performance.

 

Quality assurance, metrology, and regulatory compliance

ProMed ensures all parts meet strict standards through robust quality management, advanced metrology, and adherence to regulatory requirements.

 

Advanced metrology, testing, environmental monitoring, and regulatory compliance

We use advanced techniques to verify part quality and regulatory readiness, including:

• Advanced metrology: CT scanning provides non-destructive internal inspection. Chromatic white light inspection measures surfaces, optical 2D inspection captures high-resolution images, and CMM confirms critical dimensions.
• Testing: Dimensional and mechanical testing, electrical validation, and rheometry confirm performance. FTIR and UV/VIS spectrometry verify materials, and pharmaceutical testing covers HPLC, drug elution, residual solvents, and water content.
• Environmental monitoring: Continuous particle counting, temperature and humidity control, and differential pressure monitoring maintain ISO standards. HEPA filter integrity checks and annual third-party certifications confirm compliance.
• Traceability: Material lot tracking links raw materials to finished products. Device History Records (DHR), Certificates of Conformance (CoC), and Certificates of Analysis (COA) support regulatory submissions.
• Sterilization support: Established relationships with gamma, e-beam, and EtO sterilization providers ensure material compatibility and reliable processing.

 

Frequently asked questions:

 

1)  What makes cleanrooms essential for medical device assembly?

Promed’s cleanrooms maintain particle counts at or below 10,000 per cubic foot, providing the contamination control required for implantable devices, patient-contact components, and sterile applications. This level of control ensures regulatory compliance and product safety.

 

2)  What elastomers can you mold in your cleanroom environment?

ProMed molds LSR and HCR elastomers, covering 10–80 Shore A durometers. We can overmold onto PEEK, titanium, polysulfone, stainless steel, nitinol, and PCBs to produce complex, high-performance components.

 

3)  What assembly processes do you perform beyond molding?

Our cleanroom services include adhesive bonding, plasma etching, priming, and metal insert welding. We also handle full product assembly, including applicators and insertion devices, maintaining tight tolerances and contamination control.

 

4)  How does plasma treatment improve bonding?

Plasma etching increases surface energy on low-energy substrates, creating reactive sites that improve adhesive bonding for polymers and metals, resulting in durable connections.

 

5)  What is CT scanning?

CT scanning provides non-destructive internal inspection, revealing hidden features without damaging silicone parts. ProMed uses it to verify complex geometries and dimensional accuracy before assembly or packaging.

 

6)  Can you handle combination drug-device products?

Yes. Our cGMP facilities support API handling, drug-eluting parts, and complete assembly. Pharmaceutical testing includes HPLC, drug elution, and material verification to ensure compliance and performance.

 

7)  What certifications do your facilities maintain?

ProMed is ISO 13485:2016 certified, FDA registered (21 CFR 820, 210/211, Part 4), and cGMP certified with regular third-party audits, supporting regulated production requirements.

 

8)  How do you ensure contamination control in environments?

Continuous particle monitoring, HEPA filtration, gowning protocols, differential pressure monitoring, and validated cleaning procedures maintain cleanroom standards. Regular audits verify compliance with ISO 14644-1 requirements.

 

9)  What experience do you have with miniature medical devices?

Our micro-molding capabilities produce parts barely larger than a human hair, including ophthalmic implants, catheters, and guidewires. We routinely produce parts with shot sizes as small as 1/50 of a gram.  Tight tolerances in controlled cleanrooms ensure precision for the most demanding applications.

 

10)  Can you support projects from prototype through production?

Yes. ProMed’s 134,000+ sq. ft. across five facilities supports scaling from prototype to commercial production, including DFM reviews, process validation, and tech transfer guidance.

 

Conclusion

Cleanroom manufacturing demands precision, regulatory compliance, and technical expertise. ProMed uses over 30 years of experience in LSR and HCR molding combined with cleanroom assembly — adhesive bonding, plasma treatment, and CT scanning — to deliver components that meet strict quality standards for medical, pharmaceutical, and security applications.

Reach out to ProMed at (763) 331-3800 or visit promedmolding.com to discuss your project and explore an integrated molding and assembly solution tailored to your requirements.

 

 

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